FDA Registration Active 🇨🇭 Switzerland

SMITH & NEPHEW ORTHOPAEDICS AG

Reg #: 9613369 · FEI: 3002807893 · Expires 2026
Products
33
Proprietary Names
410
Establishment Types
2
Classifications
33

Registration Details

Registration Name
SMITH & NEPHEW ORTHOPAEDICS AG
Registration Number
9613369
FEI Number
3002807893
Status
Active
Expiry Year
2026
Initial Importer
No
Address
SCHACHENALLEE 29, DAMMWEG 39
City
AARAU Aargau
Country
CH

Regulatory Submissions

510(k) Number
K240381

Owner / Operator

Firm Name
Smith & Nephew, Inc.
Operator Number
1020279
Address
2875 Railroad Street
City
Pittsburgh
State
PA
Postal Code
15222
Country
US
Correspondent
Lisa Ewing

US Agent

Business Name
Smith & Nephew Inc.
Contact Name
Lisa Ewing
Address
2875 Railroad St
City
Pittsburgh
State
PA
ZIP
15222
Country
US
Phone
412 4199765

Products

Device Name Product Code
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
Orthopedic Manual Surgical Instrument LXH
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Chisel, Surgical, Manual FZO
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
Screw, Fixation, Bone HWC
Plate, Fixation, Bone HRS
Clamp HXD
Mesh, Surgical, Acetabular, Hip, Prosthesis JDJ
Tray, Surgical, Instrument FSM
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
Prosthesis, Toe, Constrained, Polymer KWH
Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
Prosthesis, Hip, Hemi-, Femoral, Metal KWL
Cerclage, Fixation JDQ
Washer, Bolt Nut HTN
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
Washer, Bolt, Nut, Non-Spinal, Metallic NDG
Device, Fixation, Proximal Femoral, Implant JDO
Pin, Fixation, Smooth HTY
Impactor HWA

Proprietary Names

CATALYSTEM Femoral Stems JOURNEY GENESIS ACCURIS Closed Tendon Harvester ACL Closed Curette Elevator Rasp Bone Tap Point to Point, ACL Arm Swordfish Meniscal Rasp N8TIVE ACL Disposables Kit Multi-Sizing Block ACL Bullet Hammerhead Rotary Punch Meniscal Lift Piranha Junior ACL Disposables Guidewire Kit Passing Pin Puller Titan Removal Tool Capture Sleeve Graft, Base Lock Blunt Nose Junior Cannulated Switching Stick Graft, Suture Clamp N8TIVE ACL Tunnel Rasp Clearcut Suture Cutter Hammerhead Rotary Scissor ACL Disposables Kit Suture Clamp Tension meter N8TIVE ACL Tibial Dilator Suture Hook Bilok ST Graft Expander N8TIVE ACL Curette N8TIVE ACL Femoral Drill Guide Trocar Tunnel Expander Manta Piranha Arthroscopic Rongeur N8TIVE ACL Tibial Sheath Inserter Universal Rachet Handle ACL Open Curette N8TIVE ACL Tibial Button Impactor Beluga Retro Titan Bone Punch Crochet Hook N8TIVE ACL Depth Gage Jaws Retro Toothed Grasper N8TIVE ACL Graft Sizing Block Femoral Aimer MegaMouth Grasper Jaws Retro Junior Grasper Guidewire Aimer Chondral Pick Wissinger Rod Jaws Great White Grasper A-Tech Femoral Locator Handle N8TIVE ACL Tendon Harvester Radial Clamp Tunnel Notcher Tibial Tunnel Plug Toothless Shark Atraumatic Grasper Graft, Tissue Clamp Transverse Arm Ankle Distractor Small Joint Probe Point to Elbow, ACL Arm Transverse Bullet Marlin Long Probe ACL Tunnel Rasp Single Hole Knot Pusher Graft Board Hook A-Tech Controlled Flexion Guidewire Metal Screw Driver Shaft Probe Femoral Locator Lobster Claw Suture Retriever Cuff Elevator Removal Tool Driver; MTO DRIVER 3.5MM 1.5MM CANN W/HUD ADAP; MTO DRIVER BIORCI W/HUDSON ADAPTOR Graft Bar Holder Jaws Tigar Shark Grasper Cannula Driver Ankle Distractor Strap Graft Assist, Board TRIGEN Slap Hammer Tapered Tap Depth Probe Slotted Tendon Harvester REFLECTION EMPERION Adaptor Inserter Tip Rotation Medical Mini-Open Instrument Kit PERI-LOC Rotation Medical Arthroscopic Instrument Kit TANDEM Integra Glenoid Holder Integra Surgical Instrument - Driver LARGE QWIX QWIX Biosure Guide Wire, 1.2mm x 9 inch, Box of 5, Sterile PANTA 1.5mm Guidewire, 12", 72202189 Cannuflex 9" Blunt Guidewire, 72202807 Integra Surgical Instrument Set Awl straight 3.8mm, 72202986 Accu-Pass Suture Shuttle, Monoflement Size No. 1, Single Pack, Sterile - 72201361 Accu-pass suture shuttle, crescent, 7210427 Wire and pin pac (C) Integra Pin Puller Accu-pass suture shuttle, Big Curve Accu-pass suture shuttle left 45 degree, 7210423 Integra Surgical Instrument - Planer Accu-pass suture shuttle 45 degree up, 7210425 LABELS FOR RING MODULE TIBIAXYS Guidewire 1.5mm x 229mm Suretac 6mm Guidewire, 72202809 Accu-pass suture shuttle, straight, 7210426 Twinfix AB 5mm threaded dilator, 72200819 Endobutton Pin Passing 2.4mm Trocar Round Oval Sizing Guide Wire and pin pac (B) Beath pin 2.4mm, 72202815 Biosure 1.2mm x 18", 72201201 Guide wire 2mm, 15", 7207222 Wire and pin pac, 7207738 Guidewire 2.4mm Drill Tip, guide wire, 12", 7207221 Guidewire, Nitinol 1.2mm x 45cm Accu-pass suture shuttle 70 degree, Upbend, 72200419 Passing pin Spade tip 3mm, 72202814 guide wire 2mm Accu-pass suture shuttle right 45 degree Awl tapered 3.8mm Twinfix AB 6.5mm threaded dilator, 72200820 Pliers, Compaction, 9MM PCL Guidewire, 7207284 Arthroscopic needle, 72202825 Awl, tap, driver, dilator MAVERICK MINI Extremities Guide, Universal TWINFIX 3.8 MM STRAIGHT AWL, REUSABLE RCI 7.5 MM TIBIAL STEPPED ROUTER SWISS RAIL CLAMP (LATERAL DSTRCTR SYS) RCI 7.5 MM FEMORAL STEPPED ROUTER 8MM TENDON FORK KNEE HOLDER CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 15 INCH 38 CM, BLUNT TIP, STERILE SMALL INSERTER DSP MTO GUIDEWIRE THREADED 1.5MM X 45CM SUTURE NEEDLE SHUTTLE STERILE 3.5 MM DILATOR GUIDEWIRE CANNFLEX 9 BLUNT TIP EUR/UK LATERAL RAIL CLAMPS 2 0.394 INCH X 0.984 INCH US LATERAL RAIL CLAMP 2 RCI 7 MM FEMORAL STEPPED ROUTER OPEN CURETTE 6MM REVERSE CUT XL 6.5MM DILATOR US SUPINE RAIL CLAMPS 2, 0.375 INCH X 1.125 INCH 1 CM X 2.9 CM WHIPKNOT SOFT TISSUE CINCH 5 SUTURE 2.7 MM DILATOR DENYER RAIL CLAMP (LATERL DSTRCTR SYS) Rotation Tendon Marker AWL STRAIGHT 3.8MM DISPOSABLE TruKor Gauge LOCKING WRENCH 8MM BICEPTOR TAP MANUAL INSTRUMENT TRAY OPEN CURETTE 4.5MM XL Tendon Stabilizing Guide 7MM DILATOR MTO AWL-DILATOR TF ULTRA 4.5 CORTICAL BIORAPTOR KNOTLESS INLINE DRILL GUIDE, SPIKE TIP 5 MM ANTI-IMPINGEMENT DEVICE, USED WITH 9 MM AND 10 MM GRAFTS RCI 8.5 MM FEMORAL STEPPED ROUTER RCI 6.5 MM FEMORAL STEPPED ROUTER BI-GRIP PIN PULLER GUIDE WIRE BEATH PIN 2.4 MM STERILE 7MM TENDON FORK SWISS RAIL CLAMP (SUPINE DSTRCTR SYS) PASSING PIN, 3 MM, SPADE TIP RCI 6.5 MM TIBIAL STEPPED ROUTER WELL LEG HOLDER WITH LEATHER BOOT TWINFIX AB 6.5 THREADED DILATOR TROCAR-TIP PASSING PIN, 2.4 MM X 17 INCH, STERILE STITCHER 9MM TENDON FORK ARTHROSCOPIC NEEDLE STERILE REPLACEMENT LEATHER BOOT 1 TWINFIX AB 5 THREADED DILATOR SCREW GUIDE WIRE, 2 MM X 12 INCH 30CM, BLUNT TIP, STERILE 6 PER PACKAGE STYLET FOR STITCHER 6.5 MM DILATOR RCI 8.5 MM TIBIAL STEPPED ROUTER LOOP TIP GUIDEWIRE MTO TWINFIX ULTRA 5.5 FOR 5.5 CANNULA UNIVERSAL HIP DISTRACTOR WITH LEATHER BOOT ACCU-PASS STR SHTL BIG C STERILE BOX 1 7.5MM DILATOR MTO,SCRW DRVR,LOCKING, 2.5MM HEX, CANN GUIDE WIRE 1.2MM X 9 BOX OF 5 STERILE HAMMER SLAP DILATOR SYSTEM 4.5 MM DILATOR 7MM BICEPTOR TAP GUIDE WIRE PCL 2.4MM X10 KNOT PUSHER XL 12MM DILATOR MTO GUIDE WIRE AC JOINT 2.4 MM PLIERS, COMPACTION, 9mm ACCUPASS STR SHUTL MONOFIL -SEE72201361 1.5 MM TENDON DRILL PIN LARGE TENDON STRIPPER, CLOSED, 7.4 MM I.D. X 13.5 INCH WORKING LENGTH RCI 8 MM TIBIAL STEPPED ROUTER PERINEAL POST ARTHROPIERCE XL STRAIGHT RCI 7 MM TIBIAL STEPPED ROUTER EUR/UK RAIL CLAMP (LATERL DSTRCTR SYS) LARGE INSERTER DSP RCI 8 MM FEMORAL STEPPED ROUTER GUIDE WR 1.2MM X 12 BOX OF 5 STERILE 8.5 MM DILATOR 2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE DIRECTOR PCL ELEVATOR WITH WIRE CATCHER GD WIRE NITINOL 1.2 X 45CM 8MM DILATOR Drill for Q-FIX with Needles 9MM DILATOR ACCU-PASS SUTURE SHUTTLE 70 DEGREE 4 MM ANTI-IMINGEMENT DEVICE, USED WITH 7 MM AND 8 MM GRAFTS 6MM DILATOR TENDON STRIPPER CLOSED TENDON STRIPPER, SLOTTED, 5 MM I.D. X 12 INCH WORKING LENGTH MTO AWL-DIL TF ULTRA 5.5/6.5 CORTICAL 9.5MM DILATOR SUPINE TABLE ATTACHMENT PAD SCREW GUIDE WIRE, 1.5 MM X 12 INCH 30 CM, BLUNT TIP, STERILE BOARD, PATIENT TRANSFER ACCU-PASS SUTURE SHUTTLE, MONOFILAMENT SIZE No.1, SINGLE PACK, STERILE DENYER SUPINE RAIL CLAMPS 2 8.5MM DILATOR 10MM DILATOR GUIDE WIRE 1.2MM X18 BX OF 5 STER. 11MM DILATOR rail clamp, passing pin SL-PLUS MIA BIOLOX DELTA Chisel RENOVATION POLARCUP TC-PLUS OR30 Smith & Nephew Hip Systems PLUS EVOS POLARSTEM GENESIS II Clamp SURFIX SPIN FOREFOOT IPP-ON ENGAGE SL-PLUS SLR-PLUS Global Femoral Head Trial D-RAD SMART PACK Transverse Fixation Sterilization Tray Bilok Instrument Sterilization Tray Handheld Instrument Sterilization Tray, Small Anatomic ACL Tray Chondral Pick Sterilization Tray Graftologer Tray Large Sterilization Tray HIP Tray A-Tech ACL Sterilization Tray LEGION VLP INTERTAN PROFIX Tip Pointer VISIONAIRE D-RAD Registration Pointer SPECTRON HEX-FIX JET-X HALLU-REAM SURFIX OSTEOTOME Integra I.CO.S. ADVANSYS TTC DPR SYSTEM UNI-CP HALLU-FIX I.CO.S. XL PANTA NAIL ADVANSYS NEWDEAL HALLU-LOCK LINEAR INSTRUMENTS 15-UNIT STERILIZATION TRAY GUHL NON-INVASIVE ANKLE DISTRACTOR STERILIZATION TRAY SMALL JOINT ARTHROSCOPY SYSTEM TRAY, SURGICAL MINI-OPEN ARTHRO ASSIST LATARJET BB TRAY MOSAICPLASTY COMPLETE SYSTEM 19 INCH LENGTH X 9 INCH WIDTH X 2 INCH HEIGHT HYSTEROSCOPE SET STERILIZATION TRAY. INCLUDES SILICONE MAT, COVER, 12 POSTS, 12 TIE-DOWNS, POST REMOVAL TOOL STERILIZATION TRAY FOR FIXATION POST INSTRUMENT SYSTEM 9 INCH LENGTH X 9 INCH WIDTH X 1.5 INCH HEIGHT TRAY LARGE MULTI-PURPOSE GRAFTMASTER II SYSTEN TRAY TRAY ACL REDUX STERILIZATION STERILIZATION TRAY FOR RCI SCREW SYSTEM MINI-OPEN ARTHRO ASSIST LATARJET BB LID STERILIZATION TRAY FOR MENISCAL STICHER SET TRAY,W/LID,INNER MAT,CRUCIATE,DIL,SYS SMALL STERILIZATION TRAY WITH MAT 9.25 INCH WIDTH X 3 INCH LENGHT X 1.5 INCH HEIGHT AUTOCLAVABLE ARTHROSCOPE STERILIZATION TRAY 9.5 INCH LENGTH X 3 INCH WIDTH X 1.25 INCH HEIGHT TRAY PINPOINT AACL GUIDE SYSTEM TRAY MEDIUM MULTI-PURPOSE HYSTEROSCOPE SET STERILIZATION TRAY. INCLUDES SILICONE MAT, COVER, 12 POSTS, 12 TIE-DOWNS, POST REMOVAL TOO ARTHROSCOPIC LATARJET/BONE BLOCK TRAY ECTRA HAND HOLDER/STERILIZATION TRAY WITH COVER ARTHROSCOPIC LATARJET/BONE BLOCK LID EVOS 1.8MM X 10MM LOCKING PEG T7 EVOS DISTAL RADIUS VOLAR PLATE 7H WIDE TITANIUM 105MM EVOS DISTAL RADIUS DORSAL PLATE 3H WIDE TITANIUM 58MM EVOS DISTAL RADIUS DORSAL PLATE 3H STANDARD TITANIUM 56MM EVOS DISTAL RADIUS RADIAL COLUMN PLATE 4H TITANIUM 57MM EVOS TITANIUM 3.5MM X 10MM CORTEX SCREW T15 SELF-TAPPING EVOS DISTAL RADIUS VOLAR PLATE 4H STANDARD TITANIUM 56MM EVOS DISTAL RADIUS VOLAR PLATE 4H WIDE TITANIUM 56MM EVOS DISTAL RADIUS VOLAR PLATE 7H WIDE 100MM EVOS DISTAL RADIUS VOLAR PLATE 7H STANDARD TITANIUM 105MM EVOS DISTAL RADIUS VOLAR PLATE 7H STANDARD 100MM EVOS PROXIMAL RADIAL SHAFT PLATE 5H L 95MM EVOS TITANIUM 1.8MM X 10MM LOCKING PEG T7 EVOS DISTAL RADIUS VOLAR PLATE 5H STANDARD 76MM EVOS RADIAL SHAFT PLATE 8H 98MM EVOS DISTAL RADIUS VOLAR PLATE 5H STANDARD TITANIUM 81MM EVOS DISTAL RADIUS VOLAR PLATE 4H WIDE 56MM EVOS DISTAL RADIUS VOLAR PLATE 3H STANDARD TITANIUM 48MM EVOS DISTAL RADIUS VOLAR PLATE 5H WIDE TITANIUM 83MM EVOS DISTAL ULNA PLATE 7H TITANIUM 34MM EVOS DISTAL RADIUS INTERMEDIATE COLUMN PLATE 4H TITANIUM 54MM EVOS DISTAL RADIUS VOLAR PLATE 10H STANDARD TITANIUM 141MM EVOS DISTAL RADIUS VOLAR PLATE 5H WIDE 78MM EVOS DISTAL RADIUS VOLAR PLATE 3H STANDARD 48MM EVOS DISTAL RADIUS VOLAR PLATE 4H STANDARD 56MM EVOS DISTAL RADIUS VOLAR PLATE 3H WIDE TITANIUM 48MM EVOS DISTAL RADIUS VOLAR PLATE 3H WIDE 48MM EVOS TITANIUM 3.5MM X 10MM LOCKING SCREW T15 SELF TAPPING EVOS DISTAL RADIUS VOLAR PLATE 10H RIGHT STANDARD 138MM OR3O Dual Mobility System Genesis Uni Knee System JOURNEY Uni Knee System JOURNEY II XR Bi-Cruciate Retaining Knee System JOURNEY II Uni Knee System JOURNEY PFJ System JOURNEY II CR Knee System JOURNEY BCS and II Knee Systems Legion Hinge Total ANTHEM Total Knee System Journey II UK Knee System CONTOUR ECHELON CPCS SMF SYNERGY ACCORD R3 MDF SL PLUS ANTHOLOGY MIA TANDEM Hip System INTERFIT TC-100 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 42MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 40MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 48MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 42MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 32MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 38MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 38MM 4MM CANNULATED CAPTURED SCREW 34MM Stainless Stee 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 44MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 48MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 34MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 46MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 46MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 44MM 4MM CANNULATED CAPTURED SCREW 38MM Stainless Steel 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 36MM 4MM CANNULATED CAPTURED SCREW 32MM Stainless Steel 4MM CANNULATED CAPTURED SCREW 42MM Stainless Steel 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 36MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 30MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 32MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 34MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 50MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 50MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 40MM 4MM CANNULATED CAPTURED SCREW 44MM Stainless Steel 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 30MM Impactor SOLUSTAPLE BIRMINGHAM HIP Dual Mobility Insert GENESIS II KNEE SYSTEM LEGION KNEE SYSTEM PROFIX KNEE SYSTEM

Establishment Types

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