FDA Registration Active 🇺🇸 United States

ARTHREX, INC.

Reg #: 1220246 · FEI: 1220246 · Expires 2026
Products
120
Proprietary Names
198
Establishment Types
2
Classifications
120

Registration Details

Registration Name
ARTHREX, INC.
Registration Number
1220246
FEI Number
1220246
Status
Active
Expiry Year
2026
Initial Importer
No
Address
1370 Creekside Blvd
City
Naples
State
FL
ZIP
34108
Country
US

Regulatory Submissions

510(k) Number
K112237

Owner / Operator

Firm Name
ARTHREX, INC.
Operator Number
1220287
Address
1370 CREEKSIDE BLVD., --
City
Naples
State
FL
Postal Code
34108
Country
US
Correspondent
Barry Dietz

Products

Device Name Product Code
Screw, Fixation, Bone HWC
Fastener, Fixation, Biodegradable, Soft Tissue MAI
Fastener, Fixation, Nondegradable, Soft Tissue MBI
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Cerclage, Fixation JDQ
Tray, Surgical, Instrument FSM
Shoulder Prosthesis, Reverse Configuration PHX
Pin, Fixation, Smooth HTY
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
Software For Diagnosis/Treatment OSN
Probe HXB
Staple, Fixation, Bone JDR
Dressing, Compression MHW
Syringe, Piston FMF
Plate, Fixation, Bone HRS
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
Bur, Surgical, General & Plastic Surgery GFF
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon OWY
Electrosurgical, Cutting & Coagulation & Accessories GEI
Operating Room Accessories Table Tray FWZ
System, Suction, Lipoplasty For Removal QPB
Camera, Television, Surgical, Without Audio FWB
Mallet HXL
Arthroscope HRX
Rod, Fixation, Intramedullary And Accessories HSB
Blade, Scalpel GES
Suture, Nonabsorbable, Silk GAP
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
Washer, Bolt Nut HTN
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Protector, Skin Pressure FMP
System, External Fixator (With Metallic Invasive Components) NDK
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
Instrument, Special Lens, For Endoscope FEI
Platelet And Plasma Separator For Bone Graft Handling ORG
Instrument, Biopsy KNW
System, Image Processing, Radiological LLZ
Punch, Surgical LRY
Gauge, Depth HTJ
Expander, Surgical, Skin Graft FZW
Pin, Fixation, Threaded JDW
Adaptor, Holder, Syringe IQG
Saw, Powered, And Accessories HAB
Wrap, Sterilization FRG
Goniometer, Ac-Powered KQX
Forceps, General & Plastic Surgery GEN
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
System, X-Ray, Angiographic IZI
Laparoscope, General & Plastic Surgery GCJ
Confocal Optical Imaging OWN
Light, Surgical, Fiberoptic FST
Filler, Bone Void, Calcium Compound MQV
Bit, Drill HTW
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
Total Shoulder Arthroplasty System QHQ
Blade, Saw, General & Plastic Surgery, Surgical GFA
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Display, Cathode-Ray Tube, Medical DXJ
Insufflator, Endoscopic Vessel Harvesting OSV
Insufflator, Laparoscopic HIF
Tubing, Noninvasive GAZ
Apparatus, Traction, Non-Powered HST
Passer HWQ
Bone Wedge PLF
Support, Patient Position CCX
Forceps HTD
Wrench HXC
Staple Driver HXJ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
Dressing, Wound, Drug FRO
Reamer HTO
Dilator, Lachrymal HNW
Instrument, Cutting, Orthopedic HTZ
Holder, Camera, Surgical FXR
Template HWT
Driver, Prosthesis HWR
Twister, Wire HXS
Pliers, Surgical HTC
Component, Traction, Invasive JEC
Suture, Nonabsorbable, Synthetic, Polyester GAS
Retention Device, Suture KGS
Instrument, Manual, Surgical, General Use MDM
Bender HXW
Catheter, Irrigation GBX
Handle, Scalpel GDZ
Orthopedic Manual Surgical Instrument LXH
Accessories, Arthroscopic NBH
Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
Shoulder Arthroplasty Implantation System QHE
Forceps, Rongeur, Surgical EMH
Prosthesis, Toe, Hemi-, Phalangeal KWD
Guide, Drill, Ligament LXI
Clamp HXD
Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
Staple, Absorbable MNU
Medical Device Data System OUG
Table And Attachments, Operating-Room BWN
System, Facet Screw Spinal Device MRW
Needle, Suturing, Disposable GAB
Hook, Bone KIK
Mesh, Surgical, Polymeric FTL
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon OWX
Loop, Wire JYQ
Finger Cot LZB
Component, Traction, Non-Invasive KQZ
Balance, Analytical JQO
System, Digital Image Communications, Radiological LMD
Sterilizer, Steam FLE
Drape, Surgical, Exempt PUI
Dressing, Wound, Hydrophilic NAC
Camera, Surgical And Accessories KQM
Source, Carrier, Fiberoptic Light EQH

Proprietary Names

Arthrex MicroSuture Anchors orthopedic manual instrument Pin, Fixation, Smooth BIOCOMPOSITE Dressing, Compression Elastic bandage DOUBLE SYRINGE (ACP) SYSTEM Arthrex PushLock VARIOUS BURS Arthrex PCL TightRope FIBERTAPE smooth or threaded metallic bone fixation fastener Arthrex FiberTak Suture Anchors OPES ELECTRODES AND ACCESSORIES RF device, blade, hook ARTHROSCOPY LEG HOLDER Arthrex SwiveLock Anchors Suction Lipoplasty Accessories Camera, Television, Surgical, Without Audio Mallet ARTHROSCOPY PUMP Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System Manual surgical instrument for general use. ACL TightRope Double Bundle ACCIN Uni-Knee System BIO-PIN Arthrex Tibial GraftBolt WASHER SHAVER SYSTEM General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure BIO-CORKSCREW FT EXTERNAL FIXATOR SYSTEM COBE Angel Whole Blood Separation System Instrument, Special Lens, For Endoscope ACCIN Total Knee System FiberTak DR iBalance Syringe, piston BI-CORTICAL BIO-POST AND WASHER Arthrex Low Profile Screws single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes Arthrex Small External Fixation System Adaptor, Holder, Syringe saw blade AESCULAP STERILCONTAINER SYSTEM Arthrex Fracture System FiberTape Fiberstick FiberWire AOS HUMERAL NAI Graft Delivery Device with Integrated Stylet BIOCOMPOSITE SUTURE ANCHORS Arthrex Univers II Glenoid Components Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener Forceps, General & Plastic Surgery ACCIN Patellofemoral System SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) Arthroscope Sheath DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER PUSHLOCK HATRIC CONTINUOUS WAVE III drill bit ACL TightRope SHAVER BLADES ACCIN Bipolar Head System BIO-COMPRESSION SCREW display, cathode-ray tube, medical Arthrex Graft-Anchor Laproscopes UNIVERS SHOULDER Insufflator 50L FM134 TRIM-IT FAMILY Arthrex BioSuture Nonabsorbable poly(ethylene terephthalate) Surgical Suture Sutter CURIS RF Generator fixation plate SHOULDER HOLDER Apparatus, Traction, Non-Powered Orthopedic manual surgical instrument, Passer Arthrex Univers Apex Metallic Bone Fixation Biosync Bone wedge Biosync Fastener, Fixation, nondegradable, soft tissue Fracture Plates & Screws SUPPORT, PATIENT POSITION APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Arthrex Suture MINI TIGHTROPE Wrench Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories LATERAL SUPERIOR CLAVICLE PLATE LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE LEFT AND RIGHT; ANTERIOR CLAVICLE PLA ARTHROERESIS IMPLANT Arrowhead Mini-Rail Fixator INTERFERENCE SCREWS Arthrex Univers II Shoulder Prosthesis Arthroscope Bio-Composite SutureTak Thrombinator System for use with the Arthrex Angel Concentrated Platelet Rich Plasma (PRP)System cart, emergency, cardiopulmonary Stimublast Arthrex Pushlock SUTTER ELECTROSURGICAL CABLES INTERFERENCE SCREW TENODESIS FAMILY Arthrex Biocomposite Transfix elevator, surgical, general & plastic surgery Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi HUMERAL FRACTURE PLATE COMPRESSION STAPLE BIOCOMPOSITE INTERFERENCE SCREW Arthrex iBalance BiCompartmental Arthroplasty System Arthrex Plates, Screws, and Staples Holder, Camera, Surgical Arthrex iBalance TKA System Knee Joint Patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Arthrex Fracture Plates Orthopedic Template RETROBUTTON Driver, Prosthesis TAK FAMILY FIBERWIRE BUTTON REPAIR KIT UNIVERS FRACTURE BIO-FASTAK SUTURE ANCHOR DOLPHIX EXTERNAL FIXATION SYSTEM TWISTER, WIRE Arthrex Tibial GraftBolt Pliers, Surgical EXTERNAL FIXATION CLAMP 5 MM PIN X9.5MM ROD MODEL 1151-100 EXTERNAL FIXATON CLAMP 9.5MM ROD 40 L HIGH FLOW INSUFFLATOR F108 Viscogel/Viscospray BIO-BUTTON Instrument, manual, surgical, general use Procellera Composite Antibacterial Wound Dressing Accessories for the SixFix® Hexapod Fixator BENDER Arthrex Ankle Fusion Plating System Catheter, Irrigation handle, scalpel knee joint patellofemorotibial polymer/metal/polymer semi-constrained Arthrex iBalance Patella Implant, Dome OSTEOTOMY SYSTEM ORTHOPEDIC MANUAL INSTRUMENTS VARIOUS INSTRUMENTS Arthrex Minimally Invasive Ankle Fusion Plate Arthrex Compression Plates DISCOSCOPES, CERVICAL ENDOSCOPES LOW PROFILE PLATE AND SCREW SYSTEM Univers II Forceps, Rongeur, Surgical EXTERNAL FIXATOR ST.A R 90 F4 ANATOEMIC PROSTHESIS ARTHREX ANATOEMIC P Arthrex Distal Extremity Plate System Clamp Dual Wave Pump FASTAK SUTURE ANCHOR MINI BIO-ANCHOR Accessories, Photographic, For Endoscope (Exclude Light Sources) UNIVERS II CORKSCREW ANCHORS Arthrex BioComposite SutureTak BIO-POST AND WASHER fixation pin Table Attachments, Operating-Room OSTEOTOMY PLATE PARS Needle Mini TightRope CMC hook, bone PROSTOP PLUS Arthrex Knotless SutureTak Anchor Loop, wire FINGERSHIELD Component, Traction, Non-Invasive MENISCAL DART, DARTSTICK, CHONDRAL DART PROWICK VARIOUS IMPLANTS Balance, Analytical Arthroscopes System, Digital Image Communications, Radiological INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT CONTAINER SYSTEM Arthrex PushLock Tenodesis Anchor Drape, Surgical, Exempt MENISCAL CINCH Arthrex Univers CA Heads Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis Camera Heads SHORT LATERAL SUPERIOR CLAVICLE PLATE LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT Source, Carrier, Fiberoptic Light BIO-ABSORBABLE CORKSCREW

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device