# Smith & Nephew, Inc.

- Location (FDA's records): Memphis, TN
- FDA decisions: 556 (1980–2026): 550 510(k) clearances, 1 De Novo grant and 5 original PMA approvals
- Names in FDA's records: Smith & Nephew, Inc. (538); Smith & Nephew (16); Smith+Nephew (1); Smith+Nephew, Inc. (1)
- Product codes: JWH (49), HRS (37), LPH (32), HWC (27), LZO (24), MBI (23), HRX (19), KTT (16), GCJ (15), OMP (14), MEH (13), HSX (13)
- 510(k) review time since 2016: median 86 days, against 106 for FDA's reviews in the same codes and years (58 of 101 faster)
- Predicates its devices cite: 1,509 (919 its own); citations of its devices by later devices: 1,447 (919 its own)
- Recalls linked to its devices: 416 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smith & Nephew Richards, Inc.: 119 (https://510kreport.com/company/smith-nephew-richards)
- Plus Orthopedics: 47 (https://510kreport.com/company/plus-orthopedics)
- Synthes (Usa): 29 (https://510kreport.com/company/synthes-usa)
- Richards Medical Co., Inc.: 26 (https://510kreport.com/company/richards-medical)
- Smith & Nephew, Inc., Orthopaedic Div.: 22 (https://510kreport.com/company/smith-nephew-orthopaedic-div)
- Acufex Microsurgical, Inc.: 16 (https://510kreport.com/company/acufex-microsurgical)
- Richard'S Medical Equip., Inc.: 16 (https://510kreport.com/company/richard-s-medical-equip)
- Zimmer, Inc.: 15 (https://510kreport.com/company/zimmer)

## Firms that cite its devices most
- Medacta International S.A.: 18 (https://510kreport.com/company/medacta-international)
- United Orthopedic Corporation: 16 (https://510kreport.com/company/united-orthopedic)
- Arthrex, Inc.: 16 (https://510kreport.com/company/arthrex)
- OrthoPediatrics Corp.: 14 (https://510kreport.com/company/orthopediatrics)
- Lima Corporate S.P.A.: 13 (https://510kreport.com/company/lima-corporate)
- Globus Medical, Inc.: 12 (https://510kreport.com/company/globus-medical)
- Stryker Corp.: 11 (https://510kreport.com/company/stryker)
- Smith & Nephew Medical Limited: 11 (https://510kreport.com/company/smith-nephew-medical)

## Its most-cited devices
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) (1999), cited by 36
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) (2003), cited by 28
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories (2009), cited by 23
- K052792: Anthology Hip Stem (2005), cited by 19
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories] (2000), cited by 19
- K983942: Intramedullary Nail System, Locking Screw, Nail Cap (1998), cited by 18

## Recent decisions
- K263348: Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Black knotless and one Blue MINITAPE Suture; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Blue knotless and one Black MINIT (Oct 23, 2026)
- K261462: LANDMARK Total Knee System (Sep 8, 2026)
- K261968: Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) (Jul 9, 2026)
- DEN250037: TESSA Spatial Surgery System; INTELLIO Tablet (72205455) (Jul 6, 2026)
- K254084: AETOS Shoulder System - CONCELOC Glenoids (Apr 6, 2026)
- K252416: AETOS Shoulder System Meta Humeral Prosthesis Size 0 (Oct 29, 2025)
- K252129: AETOS Shoulder System Stemless Humeral Prosthesis (Oct 3, 2025)
- 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) (Jun 25, 2025)

Source page: https://510kreport.com/company/smith-nephew