Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613369

FEI Number

3002807893

Entity Name

SMITH & NEPHEW ORTHOPAEDICS AG

City/State/Country

AARAU Aargau, CH

Establishment Address

SCHACHENALLEE 29, DAMMWEG 39, AARAU Aargau CH-5001, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Smith & Nephew, Inc. (Owner Number: 1020279)

Owner / Operator Contact Address

2875 Railroad Street, Pittsburgh, PA 15222, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K933958

PMA Number

N/A

All Registered Proprietary Names

CATALYSTEM Femoral Stems JOURNEY GENESIS ACCURIS CATALYSTEM Femoral Stems 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 JOURNEY Inserter Tip Rotation Medical Mini-Open Instrument Kit PERI-LOC Rotation Medical Arthroscopic Instrument Kit TANDEM Integra Glenoid Holder GENESIS 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 SL-PLUS MIA POLARCUP TC-PLUS OR30 TANDEM Smith & Nephew Hip Systems REFLECTION PLUS EVOS JOURNEY POLARSTEM GENESIS II PERI-LOC Clamp SURFIX SPIN FOREFOOT IPP-ON TIBIAXYS ENGAGE POLARSTEM SL-PLUS SLR-PLUS POLARCUP POLARSTEM 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 GENESIS VLP TANDEM INTERTAN EMPERION PROFIX Tip Pointer VISIONAIRE PERI-LOC REFLECTION D-RAD Registration Pointer SPECTRON HEX-FIX JET-X TRIGEN HALLU-REAM SURFIX OSTEOTOME IPP-ON LARGE QWIX Integra I.CO.S. ADVANSYS TTC DPR SYSTEM UNI-CP HALLU-FIX I.CO.S. XL QWIX TIBIAXYS PANTA NAIL ADVANSYS NEWDEAL HALLU-LOCK FOREFOOT 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 MAVERICK MINI 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 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 GENESIS LEGION POLARSTEM BIOLOX DELTA CONTOUR ECHELON CPCS SMF SYNERGY ACCORD R3 SPECTRON MDF SL PLUS ANTHOLOGY EMPERION REFLECTION MIA PROFIX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-06-28
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-06-28
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-06-28
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-06-28
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2013-01-07
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2013-01-07
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-11-17
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-11-17
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-11-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2006-10-05
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2015-07-07
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2015-07-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-07-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-02-22
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1992-03-17
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-12-26
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2012-12-26
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2012-12-26
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-02-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-02-22
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2013-02-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-04-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-11-13
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2008-02-09
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-08-03
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2022-08-03
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2022-08-03
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-08-03
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-08-03
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2022-08-03
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2022-08-03
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-01-11
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-01-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-02-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-11-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-11-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-14
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2013-11-14
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-11-14
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-11-14
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2013-11-14
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	1978-02-22
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2015-05-22
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2015-05-22
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2015-05-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-05-22
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-02-22
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2013-02-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-02-22
JDJ	Mesh, Surgical, Acetabular, Hip, Prosthesis	General, Plastic Surgery	Class 2	878.3300	2013-02-22
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-02-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-02-22
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2013-02-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-02-22
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-02-22
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2014-05-19
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2014-05-19
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2014-05-19
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-05-19
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2014-05-19
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2014-05-19
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2014-05-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-06-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-06-12
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2006-10-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-08-10
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-10-25
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2023-06-01
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2023-06-01
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-06-01
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2023-06-01
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2023-06-01
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2023-06-01
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	Class 2	888.3720	2023-06-01
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-02-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-08-05
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-02-22
JDG	Prosthesis, Hip, Femoral Component, Cemented, Metal	Orthopedic	Class 2	888.3360	2013-08-09
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-08-09
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2013-08-09
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-08-09
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-08-09
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2013-08-09
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Orthopedic	Class 2	888.3360	2013-08-09
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2013-08-09
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-08-09
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-08-09
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2013-08-09
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2013-08-09
JDJ	Mesh, Surgical, Acetabular, Hip, Prosthesis	General, Plastic Surgery	Class 2	878.3300	2013-08-09
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-04-01

Official Correspondent

Lisa Ewing

US Agent Details

Lisa Ewing Business: Smith & Nephew Inc. Email: lisa.ewing@smith-nephew.com Phone: (412) 4199765

Related Public Records

Same Entity

Smith & Nephew, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223112	Smith & Nephew, Inc.	MAVERICK Mini External Fixation System	2022-12-08
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613369. Last updated year: 2026. Please use registration number 9613369 when referencing this establishment in official correspondence.