Product Code: MBI FDA class 2 21 CFR 888.3040

Fastener, Fixation, Nondegradable, Soft Tissue

Orthopedic

The nondegradable soft tissue fixation fastener is a permanent orthopedic implant used to anchor soft tissue structures such as ligaments or tendons to bone, remaining in place indefinitely after implantation. It is classified as FDA Class II under 21 CFR 888.3040 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MBI and it carries an implant flag. Full GMP quality system requirements apply and it does not sustain life.

510(k)s
565
FEI Numbers
263
Registration Numbers
263
Unique Applicants
195
Years Active
30

Basic Information

Product Code
MBI
Device Class
FDA class 2
Regulation Number
888.3040
Medical Specialty
Orthopedic
Review Panel
OR
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 565 510(k) clearances via K numbers.

K Number Device Name
K251145 Arthrex PushLock Suture Anchors
K251933 SnugFit ASA Extension
K251627 BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)
K251530 CONMED Argo Knotless® Anchor
K250844 PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop
K242477 Shoulder Soft Tissue Anchors
K250596 Arthrex FiberTak Suture Anchor
K243988 RootMend MRR
K250424 Arthrex TightRope Soft Button, RT
K250238 WasherCap™ Fixation System
K244015 SuperBall-RC™
K243665 Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)
K243726 Osprey Suture Anchor
K243712 WasherCap™ Mini Fixation System (Model 45)
K244025 Argo Knotless GENESYS Anchor
K241234 OTS 25-L (100-5)
K242529 Tigon Medical All-Suture Anchors (ASA)
K243470 Fix2Lock (PEEK Self Punching)
K242494 OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct
K243323 Iconix Knotless Anchor
K243203 OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor
K241695 Extremity All Suture System
K242296 VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)
K233601 Fixone Meniscal Repair
K241864 Grappler Interference Screw System
K240835 Suture Button Repair System
K241577 Iconix® Anchor
K241435 Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue
K241235 Arthrex TightRope II
K232941 Megaloop Button System
K240719 OC JuggerKnot Soft Anchor
K240594 Grappler Suture Anchor R3FLEX IOL System
K240407 ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor
K240213 Iconix Knotless Anchor
K240194 ProCinch, QuadCinch
K233893 AlphaVent Knotless SP PEEK Anchor
K233730 Footprint Mini PK, 3.5mm Suture Anchor
K231033 CEPTRE® Knotted UHMWPE Suture PEEK Anchor
K230891 SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant
K233659 Suture Wing
K233429 OTS 25 (100-1)
K233552 IDEAL Ziploop
K232973 Arthrex Knee FiberTak® Button Suture Anchor
K233468 Iconix Anchor
K232886 INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
K232742 Arthrex FiberTak Suture Anchor
K232725 Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
K232683 Knotilus+ PEEK Knotless Anchor
K233258 Shadow Knotless All-Suture Anchors
K232492 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor
K232411 JuggerKnot Soft Anchor OC
K231078 All-Suture Anchor
K232592 CITRELOCK® DUO
K230517 Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)
K232457 Q-FIX ULTRA All-Suture Anchor
K232340 Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor
K231093 AlphaVent Suture Anchors
K230094 Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
K231867 Grappler Suture Anchor System
K231376 Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)
K231857 Arthrex TightRope II
K232005 HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)
K231404 T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button
K223114 Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
K231278 Knotless Suture Anchor
K231322 Fix2Lock(PEEK Self Punching)
K231002 Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)
K231330 FiberTak® Suture Anchor
K230874 Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
K223860 Integrity™ Bone Staple Fixation System
K231113 Arthrex FiberTak Suture Anchor
K231128 JuggerKnot Soft Anchor
K230655 PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw
K230123 Apollo Knotless Suture Anchor
K230544 SnugFit All-Suture Anchor extension
K230568 FiberTak Suture Anchor
K222423 Fixone All Suture Anchor
K223889 Stativ® Knotted UHMWPE Suture Anchor
K220464 Tigon Medical Gryphon Anchor Line
K223878 Aevumed RAPID Suture Anchors
K230433 Arthrex Knotless FiberTak Suture Anchor
K220966 SINEFIX
K223589 Grappler Suture Anchor R3FLEX IOL System
K223582 MectaLock TI Triple Loaded Suture Anchor
K230212 OrthoButton AL
K222971 ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device
K222574 Simparo Anchor Line Fixation System
K223284 SutureLoc™ Implant
K222589 Flexible Suturing System with Anchors (FSSA)
K223795 FairFix QT Adjustable Button
K221396 Arthrex FiberTak Suture Anchor
K213110 AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor
K222363 Aevumed PHANTOM™-LP Suture Anchors
K213018 Auxilock GFS Mini, GFS II Large, and GFS Ultimate
K222763 Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors
K212197 WasherCap Fixation System
K222091 Grappler Suture Anchor System
K221731 FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
K213109 Auxilock Draw Tight Suture-Based Anchor
K222169 FairFix Adjustable Button System
K222161 Arthrex Knotless FiberTak Biceps Suture Anchor
K220901 S-Core Implant System
K213104 Auxilock Titanium Screw-In Suture Anchor
K221502 Parcus Synd-EZ SS
K221364 Mitek TIGHT-N Anchor
K221389 FairFix AM Adjustable Button FairFix PSP Adjustable Button
K221135 X-Twist PEEK Suture Anchor
K220757 Argo Knotless SP Anchor
K220797 FootHold System
K212381 VersaTap, VersaLat, DueLock, VersaTi, MiniTi
K212739 ActiFlip
K211322 Paratrooper Plantar Plate Repair System
K211502 Alpha Vent PEEK Suture Anchor
K211049 Tigon Medical Button System
K211002 Grappler Suture Anchor System
K202663 Suture Wing
K202763 Fix2Lock (PEEK Self Punching)
K203121 Responsive Arthroscopy Thunderbolt System
K203259 FairFix Adjustable Button System
K210498 Betta Link Knotless Implant System
K210078 Stryker ProCinch Adjustable Loop Device
K202662 Parcus Titanium Interference Screws
K203740 JuggerKnot Soft Anchor
K203385 TenoTac Soft Tissue Fixation System
K203794 HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture
K203485 SnugFit All-Suture Anchor
K202291 Button Loop
K192709 Fixone All Suture Anchor
K203268 Arthrex FiberTak Suture Anchor
K202883 Sterile bone screw (PEEK ACL screw)
K193377 TopLock Anchor System
K202444 Knotless TensionTight Button Implant System
K202355 Stryker Omega PEEK Knotless Anchor System
K202178 VersaLoop Anchor System
K200428 Multi-Drive Interference Screw System
K193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws
K202581 Arthrex TightRope II
K202259 Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip
K202193 PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction
K192949 Flower Suture Anchor Set
K202399 OrthoButton FL
K202153 Responsive Arthroscopy Suture Anchor System
K200503 ATL Anchors
K201636 Hercules Suture Anchor System
K201883 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor
K201083 Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors
K200949 HEALIX ADVANCE Anchor with DYNATAPE Suture
K193108 Bonecam Suture Anchor
K200341 Arthrex FiberTak Suture Anchor
K192810 Apollo Suture Anchor System
K193402 ALLthread PEEK Suture Anchor
K200028 Coronet Soft Tissue Fixation System
K193245 Dunamis PunchTac Suture Anchors
K193165 MectaFix CL Fixation Button with Continuous Loop
K193461 MectaLock All-Suture Anchors
K191677 MectaTap TI Suture Anchor
K191227 Paratrooper Plantar Plate Repair System
K193295 Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor
K193606 Y-Knot OneStep Anchor
K192942 ALLthread Titanium Suture Anchor
K192750 AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip
K193092 TunneLoc Tibial Fixation Device
K191426 FiberTak Button
K192964 Parcus Synd-EZ SS
K191783 Parcus Synd-EZ Ti
K192428 AFX Femoral Implant with Inserter
K191459 JuggerStitch Meniscal Repair Device
K190288 Arthrex Tenodesis Button
K191300 MectaLock Ti Suture Anchor
K191319 Dunamis Fixation Button System
K190774 RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant
K191053 Xtreme-Loop
K191204 Infinity Fixation System
K190915 OsteoFab Suture Anchors
K191483 HEALIX ADVANCE Anchor with DYNA+TAPE Sutures
K190892 MectaScrew PEEK Interference Screw
K190474 MectaLock PEEK Suture Anchor
K190125 FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
K190375 Parcus ATLAS
K190728 Arthrex SwiveLock Anchors
K190446 Responsive Arthroscopy Wedge Push-In Suture Anchors
K190333 Paradigm All-Suture Anchor 1.8mm, White/Black #2
K183690 Tenodesis Screw System
K182941 HEALIX ADVANCE SP PEEK Anchor
K183279 HEALIX Ti ANCHOR with DYNACORD
K183331 Parcus GFS BTB
K182507 Tigon Medical Tissue Anchors
K181076 Responsive Arthroscopy Wedge Push-In Suture Anchors
K182898 TenoTac Soft Tissue Fixation System
K181086 Cortical Fixation Systems
K182439 TruShot with Y-Knot Shallow All-Suture Anchor
K182621 CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver
K180951 Responsive Arthroscopy Suture Anchor System
K182736 OIC Suture Anchor System
K181120 2.8 mm/3.3 mm PopLok Suture Anchors
K182446 TruShot with Y-Knot All-Suture Anchor
K182264 ICONN Revolution Knotless Suture Anchor
K181769 Arthrex FiberTak Suture Anchor
K181513 Arthrex PushLock Tenodesis Anchor
K181680 ICONN Answer II Suture Anchor
K180759 SECULOK™ Suture Anchor
K173845 Arthrex SwiveLock
K181083 Stryker All-PEEK Knotless Anchor System
K180464 AEVUMED PHANTOM Suture Anchors
K173269 KATOR Suture Anchor
K173074 ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor
K180274 Ventix Link Knotless Anchor with Inserter
K180118 Arthrex NanoSuture Anchor
K173278 ToggleLoc System
K172491 ICONN Square 2.5MM Suture Anchor
K172921 Stryker Self-Punching ICONIX
K171640 M-ARS ACL: Anatomic Ribbon Surgery System
K172186 BioWick X Implant with Driver
K172612 FiberTak DX
K171964 LigaMetrics Suture Anchors
K171725 CuffLink Implant System
K171465 Stryker Self-Punching ICONIX
K172165 Q-Fix Suture Anchor
K170388 ANCHORMAN Tibial Ligament Fixation Device
K171060 OrthoButton AL
K170877 Parcus SLiK Fix Screw
K171020 Arthrex Knotless SutureTak Anchor
K170098 ICONIX TT All Suture Anchor
K170327 Parcus SLiK Anchors
K170265 GRAVITYTM PEEK-OPTIMA Suture Anchor
K163258 CrossFT Knotless Suture Anchor with Disposable Driver
K163034 SUTUREFIX Curved Suture Anchor
K162198 GFS Ultimate
K162386 KATOR Suture Anchor
K161033 AFX™ Femoral Implant With Inserter
K160996 Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
K161001 MILAGRO ADVANCE PEEK Interference Screw
K160655 OrthoButton CL
K160319 FiberTak DR
K153585 Flip Button Suture Anchor
K160118 STROPP (Single Tunnel Repair of Plantar Plate)
K153558 Ventix Suture Anchor
K160500 Elite SPK, Compasso, Elite SPK Kit
K153667 TRUESPAN Meniscal Repair System
K152262 Ventix Knotless Anchors
K151092 Arthrex Short Suture Anchors
K153186 Adjustable Fixation Device
K153669 MultiFIX S Ultra Knotless Fixation System
K153313 SpeedLock Knotless Fixation System
K152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors
K152711 Parcus GFS Naked
K151004 PULLUP® Adjustable Juxtacortical Fixation Device
K152255 BoneCam Suture Anchors
K152236 KATOR Suture Anchor
K151220 Dunamis Interference Screw
K151601 SECURE-LOOP
K150768 JuggerKnot Soft Anchors
K150648 Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm
K151897 MultiFIX® P Knotless Fixation Device
K150715 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors
K151068 SureLock W Suture Anchor
K151314 CinchLock Flex Knotless Suture Anchor
K151660 MultiFIX S Knotless Fixation System
K151037 GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle
K143745 Arthrex Corkscrew and SwiveLock Suture Anchors
K151201 Stryker ICONIX with Needles
K151230 Arthrex FiberTak Anchors
K150424 JuggerStitch Meniscal Repair Device
K143473 Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles
K150166 Extremity Medical Suture Anchor
K143392 Quattro Bolt Tenodesis Screw
K142643 Stabilynx PEEK Suture Anchor
K142574 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,
K142653 G-Lok and G-Lok XL Extender
K142230 Apollo Suture Anchor System and Titan Screws
K140476 ARTHREX FIBERTAK SUTURE ANCHOR
K141011 G-FORCE GEN 2 SUTURE ANCHOR SYSTEM
K141711 PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE
K140879 BIOSURE HEALICOIL PK INTERFERENCE SCREW
K140324 RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
K133579 MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS
K140925 ACUMED SUTURE ANCHOR SYSTEM
K140604 MULTIFIX S KNOTLESS FIXATION SYSTEM
K132724 ICONN ANSWER SUTURE ANCHOR
K133235 THREADED PEEK K-WIRE
K133777 TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
K133606 N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL
K133469 ACUMED SUTURE ANCHOR SYSTEM
K133036 APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
K133671 ICONIX ALL SUTURE ANCHORS
K133757 GFS II STANDARD, GFS II LARGE, GFS MIMI
K133229 TITANIUM SUTURE ANCHOR
K133727 Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU
K133224 Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES
K132867 SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM
K132783 EXOSHAPE DUO SOFT TISSUE FASTENER
K130467 POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE
K122437 NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
K132461 A.I.M. SUTURE ANCHOR
K131769 CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM
K132632 TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
K132513 Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER
K132590 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA
K131635 ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
K131325 QUATTRO GL SUTURE ANCHOR
K130814 RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM
K130033 TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO
K131182 MULTIFIX S KNOTLESS FIXATION DEVICE
K131035 Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
K131683 HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
K130217 ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
K130539 HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)
K130458 KNOTLESS FIBERTAK SUTURE ANCHOR
K123485 JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
K122059 ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
K130351 NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER
K123350 ECLIPSE SOFT TISSUE FASTENER
K120740 COLS® FIXATION SYSTEM
K130196 SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR
K123651 CINCHLOCK KNOTLESS SUTURE ANCHOR
K123425 TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
K123240 SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
K122805 PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
K123579 FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
K122336 Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM
K123341 ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON
K122954 CINCHER-2.6 SUTURE ANCHOR MODEL FG-001
K120356 NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD
K121356 MICRO/MINI N-PK(H) BONE ANCHOR
K121354 MICRO/MINI N-PK(F) BONE ANCHOR
K122314 QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY
K122463 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W
K122123 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED
K120943 SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER
K120509 STRYKER ALL SUTURE ANCHORS
K120824 3.9MM REELX STT SUTURE ANCHOR SYSTEM
K121018 BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
K120841 APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR
K120942 PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC
K120096 MULTIFIX P KNOTLESS FIXATION DEVICE
K113274 FOOTPRINT ULTRA PK SUTURE ANCHOR
K113297 KNOTILUS ANCHOR SYSTEM
K120155 ARTHREX KNOTLESS SUTURETAK ANCHOR
K112526 TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
K113294 SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
K113730 PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS
K112814 CUFFINK
K112417 VARIOUS
K112960 LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE
K113299 ROG SUTURE ANCHOR
K112876 CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5
K112991 MODIFIED ROG SUTURE ANCHOR
K112296 LATERAL BUTTON
K111716 KNOTLESS SUTURE FIXATION SYSTEM
K112965 NANO SUTURE ANCHOR
K110800 META-LOCK SUTURE ANCHOR SYSTEM
K111661 ARTHREX SCAPHOLUNATE ANCHOR
K110879 BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
K111044 SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE
K111779 Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
K111590 ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR
K111631 GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..
K111399 SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75
K111397 TITAN TI SUTURE ANCHOR SYSTEM
K110545 SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
K111564 MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
K111471 EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
K110773 TORNIER INSITE FT SUTURE ANCHOR
K110781 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP
K110473 NANOTACK SUTURE ANCHOR 1.4MM
K110230 ROG KNOTLESS SUTURE ANCHOR
K110229 ROG SUTURE ANCHOR 5.5MM, 2.9MM
K103262 QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
K110145 BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR
K102539 ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM
K103145 HAMMERLOC TM TIBIAL FIXATION DEVICE
K110164 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
K101616 THE GRAPPLR AND GRAPPLR EXTENDER
K103060 ARTHREX TIBIAL GRAFTBOLT
K102660 BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS
K101126 PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS
K101437 SPEEDFIX SUTURE SYSTEM
K102262 ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL
K102443 INTRAFIX TIBIAL SHEATH
K101063 SLEEVE WITH ZIPLOOP FIXATION DEVICES
K101448 OPUS SPEEDSCREW SYSTEM
K100630 G-FORCE PEEK SUTURE ANCHOR SYSTEM
K101175 KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER
K101184 TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006
K100159 SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR
K093935 SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR
K100579 G-FORCE TI SUTURE ANCHOR SYSTEM
K093912 ARTHREX TIBIAL GRAFTBOLT
K093943 BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM
K093897 SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR
K092836 OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141
K092998 CONMED LINVATEC INTERCEPT IMPLANT
K093428 SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR
K093228 SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR
K092914 WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES
K091094 PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264
K091870 TORNIER, PITON FIXATION IMPLANT SYSTEM
K090923 PARCUS GRAFT FIXATION SYSTEM
K091549 CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM
K091503 MAGNUM MP FIXATION DEVICE
K090615 OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE
K090530 SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01
K090380 MAGNUM M FIXATION DEVICE
K090075 PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258
K083609 KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE
K083635 SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW
K083226 SMITH & NEPHEW PEEK INTERFERENCE SCREW
K083151 EXTREMITY MEDICAL SUTURE ANCHOR
K083150 G-FORCE TENODESIS SCREW
K083240 OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES
K082729 RIMCLOSE BONE ANCHOR
K083070 TOGGLELOC SYSTEM
K081348 TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD
K081511 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S
K081497 OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)
K081598 SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE
K080447 SURGICRAFT SCREW FIXATION SYSTEM
K080335 TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM
K080229 5.5 MM SUTURE LOCK BONE SCREW ANCHOR
K073481 THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES
K073226 CINCH KNOTLESS FIXATION IMPLANT SYSTEM
K072063 KFX TISSUE FIXATION SYSTEM AND ACCESSORIES
K070773 AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR
K071704 SLEEVE AND BUTTON SOFT TISSUE DEVICES
K070780 CONMED LINVATEC XO BUTTON
K071586 BIORAPTOR 2.3 PK SUTURE ANCHOR
K071520 RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X
K071374 OPUS TWINLOCK KNOTLESS FIXATION DEVICE
K070882 STRYKER PEEK TWINLOOP TAC
K071569 ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER
K070908 SMITH & NEPHEW KINSA RC SUTURE ANCHOR
K070758 STRYKER PEEK ZIP SUTURE ANCHOR
K070227 OPUS MAGNUM PI KNOTLESS FIXATION DEVICE
K070167 ENDOBUTTON DIRECT
K062739 CINCH BONE ANCHOR SYSTEM
K063577 FEMORAL INTRAFIX SCREW AND SHEATH
K063499 MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K061294 KFX KNOTLESS FIXATION SYSTEM
K061349 OPUS LABRALOCK P KNOTLESS FIXATION DEVICE
K061154 KINSA SUTURE ANCHOR
K053461 EZLOC FEMORAL FIXATION DEVICE
K052810 SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K052572 ANSPACH KNOTLESS ANCHOR
K052491 AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
K051069 NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER
K050227 THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER
K042914 OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
K042460 TI - SCREW ANCHOR SP
K041713 SUPER REVO HERCULINE SUTURE ANCHOR
K041440 OPUS MAGNUM ANCHOR WITH INSERTER
K041310 STRYKER WEDGE SUTURE ANCHOR SYSTEM
K041261 FEMORAL HOOK
K033838 TITANIUM TOGGLE BUTTON(S)
K023963 ADHOC CLAW
K022853 ENDOTACK
K022827 ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
K022207 AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
K020172 OPUS MAGNUM ANCHOR & INSTRUMENT SET
K013553 PRE-LOADED ULTRAFIX RC
K013334 ENDOFLIP
K013557 LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
K012503 METAL SCREW ANCHOR
K011912 MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
K011007 TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
K011390 BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K010457 ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
K002829 DJ ORTHOPEDICS FEMORAL ANCHOR
K003971 AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR
K003960 DJ ORTHOPEDICS TIBIAL ANCHOR
K003648 FREEDLAND TENSION SYSTEM
K010121 STERILE BUTTON PLATE
K002600 LITWIN CRUICATE ANCHOR
K994364 SYNTHES BUTTON PLATE
K000279 STAPLETAC2 BONE ANCHOR SYSTEM
K993657 ACUMED SUTURE ANCHOR
K993261 TALON ANCHOR SNAP-PAK
K992458 RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454
K992377 RC TACK
K990295 BONE ANCHOR SYSTEM III (BAS III)
K990156 MULTITAK SS BUTTONS
K990160 MICROTAC-BONE ANCHOR SYSTEM
K990095 STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K982751 IMPLEX SCREW AND WASHER SYSTEM
K983560 INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER
K984200 STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE
K983557 STRYKER WEDGE SUTURE ANCHOR
K983169 POLYMER THREADED ANCHOR
K983818 MITEK FASTIN RC ANCHOR
K983056 INNOVASIVE TIBIAL FASTENER
K982571 KSEA FLIPPTACK
K982169 SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)
K982155 SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K974847 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235
K981692 MENISCAL REPAIR DEVICE
K981967 WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE
K981764 LM ANCHOR
K981755 LM ANCHOR
K981688 ANSPACH SUTURE ANCHOR
K981193 INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER
K980595 DEPUY ORTHOTECH CATERA SUTURE ANCHOR
K980491 INNOVASIVE LINX TIBIAL LIGAMENT FASTENER
K980334 INNOVASIVE 10MM LINX HT LIGAMENT FASTENER
K973874 ACL CLIP-IN PLATE
K973775 HARPOON SUTURE ANCHORS
K980103 ACUMED SUTURE ANCHOR
K974049 INNOVASIVE LINX BT 10MM LIGAMENT FASTENER
K974345 MITEK KNOTLESS ANCHOR
K972326 PEBA ANCHOR/SUTURE COMBINATION
K974136 CRANIOFACIAL ANCHORS
K970119 MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX
K973323 ACL CLIP-IN
K973009 MITEK NON ABSORBABLE POLYPROPYLENE H FIX
K963502 CSCO FOREHEAD FIXATION SYSTEM
K973015 MULTITAK SS SUTURE SYSTEM
K972622 STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K972438 INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER
K972356 INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER
K971922 INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER
K971802 VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
K971791 VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION
K971723 FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)
K971332 AMS MAINSTAY UROLOGIC BONE ANCHOR
K971282 ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K971144 MULTITAK SS SUTURE SYSTEM
K971139 BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
K963932 PRELOADED SOFT TISSUE ANCHOR
K970423 INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE
K970292 IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW
K970316 INNOVASIVE 8MM LIGAMENT FASTENER
K970089 INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER
K964945 INNOVASIVE DEVICES ROTATOR CUFF FASTNER
K965111 STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008
K965069 ANSPACH SUTURE ANCHOR
K964927 STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8
K964786 ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K964532 MULTITAK SS SUTURE SYSTEM
K964324 MULTITAK SS SUTURE SYSTEM
K963686 ANSPACH SUTURE ANCHOR (MODIFIED)
K963288 LM BONE ANCHOR
K963812 LM BONE ANCHOR (ORTHOPEDICS)
K962511 MITEK MICRO ANCHOR
K963402 INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER
K961094 MITEK THREADED ANCHOR (MODIFICATION)
K963217 ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM
K963200 QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K962397 STATAK SOFT TISSUE ATTACHMENT DEVICE
K962194 MLI SOFT TISSUE SCREW & WASHER SYSTEM
K960825 LM ANCHOR OR OTHER PROPRIETARY NAME
K954683 QUESTLOCK ACL FIXATOR
K960516 FASTAK SUTURE ANCHOR
K960439 LM BONE ANCHOR
K960448 LM ANCHOR
K934183 BONUTTI ANCHOR
K954338 INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER
K953954 PRELOADED SOFT TISSUE ANCHOR
K953560 MITEK THREADED ANCHOR (FASTIN)
K953877 MITEK GII ANCHOR
K952237 INNOVASICE 2.8MM & 3.5MM ROC SUTURE BONE FASTENER
K951451 PEBA ANCHOR (MULTIPLE SIZES)
K953702 WASHER
K953264 QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K934327 ARTHREX SUTURE ANCHOR SCREW SYSTEM
K951565 INNOVASIVE DEVICES ROTATOR CUFF FASTENER
K953459 ACUFEX TAG ANCHOR
K944831 INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER

FEI Numbers

This FDA classification entry is associated with 263 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 263 registration numbers. Click on an entry to view related FDA registrations.