# Smith and Nephew, Inc.

- Location (FDA's records): Andover, MA
- FDA decisions: 8 (2016–2023): 7 510(k) clearances and 1 original PMA approval
- Product codes: MAI (2), GCJ (2), QRU (1), HTN (1), MBI (1), OWY (1)
- 510(k) review time since 2016: median 111 days, against 106 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 12 (2 its own); citations of its devices by later devices: 7 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- Smith & Nephew Inc., Endoscopy Division: 2 (https://510kreport.com/company/smith-nephew-endoscopy-division)
- Smith & Nephew Endoscopy, Inc.: 2 (https://510kreport.com/company/smith-nephew-endoscopy)
- Pivot Medical: 1 (https://510kreport.com/company/pivot-medical)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- Rotation Medical, Inc.: 1 (https://510kreport.com/company/rotation-medical)

## Firms that cite its devices most
- Arthrex, Inc.: 3 (https://510kreport.com/company/arthrex)
- Smith & Nephew Inc., Endoscopy Div.: 1 (https://510kreport.com/company/smith-nephew-endoscopy-div)
- Conmed Corporation: 1 (https://510kreport.com/company/conmed)

## Its most-cited devices
- K222501: Regeneten Bioinductive Implant (2023), cited by 2
- K181746: MICRORAPTOR Knotless Suture Anchor (2018), cited by 2
- K180361: MICRORAPTOR REGENESORB Suture Anchor (2018), cited by 1
- K191177: LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head (2019), cited by 1
- K183232: Double ENDOBUTTON Fixation Device (2019), cited by 1

## Recent decisions
- K222501: Regeneten Bioinductive Implant (May 11, 2023)
- K221740: Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith & Nephew Intellio 4K Camera Control Unit, Non-Network Enabled (72205448) (Oct 20, 2022)
- P210034: Agili-C (Mar 29, 2022)
- K191177: LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head (Aug 23, 2019)
- K183232: Double ENDOBUTTON Fixation Device (Mar 12, 2019)
- K181746: MICRORAPTOR Knotless Suture Anchor (Sep 28, 2018)
- K180361: MICRORAPTOR REGENESORB Suture Anchor (May 30, 2018)
- K163034: SUTUREFIX Curved Suture Anchor (Dec 7, 2016)

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