# Smith & Nephew Inc., Endoscopy Div.

- Location (FDA's records): Andover, MA
- FDA decisions: 10 (2007–2024): 10 510(k) clearances
- Product codes: MBI (3), KCT (3), OWY (1), HWC (1), HRS (1), OLO (1)
- Predicates its devices cite: 19 (1 its own); citations of its devices by later devices: 23 (1 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smith & Nephew, Inc.: 10 (https://510kreport.com/company/smith-nephew)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- Symmetry Medical: 1 (https://510kreport.com/company/symmetry-medical)
- Riley Medical, Inc.: 1 (https://510kreport.com/company/riley-medical)
- Smith and Nephew, Inc.: 1 (https://510kreport.com/company/smith-and-nephew)
- Orthopaedic Biosystems, Ltd.: 1 (https://510kreport.com/company/orthopaedic-biosystems)
- Smith & Nephew Endoscopy, Inc.: 1 (https://510kreport.com/company/smith-nephew-endoscopy)
- Innovasive Devices, Inc.: 1 (https://510kreport.com/company/innovasive-devices)

## Firms that cite its devices most
- Smith & Nephew, Inc.: 8 (https://510kreport.com/company/smith-nephew)
- Suzhou Endophix Co., Ltd.: 3 (https://510kreport.com/company/suzhou-endophix)
- Cayenne Medical, Inc.: 3 (https://510kreport.com/company/cayenne-medical)
- Smith & Nephew Endoscopy, Inc.: 1 (https://510kreport.com/company/smith-nephew-endoscopy)
- Iconn Orthopedics, LLC: 1 (https://510kreport.com/company/iconn-orthopedics)
- Synovis Orthopedic & Woundcare: 1 (https://510kreport.com/company/synovis-orthopedic-woundcare)
- Smith & Nephew Inc., Endoscopy Division: 1 (https://510kreport.com/company/smith-nephew-endoscopy-division)
- Mortise Medical, LLC: 1 (https://510kreport.com/company/mortise-medical)

## Its most-cited devices
- K093897: Smith & Nephew Footprint Ultra PK Suture Anchor (2010), cited by 10
- K073551: Smith & Nephew Instrument Trays (2008), cited by 5
- K100159: Smith and Nephew Twinfix Ultra TI Suture Anchor (2010), cited by 4
- K080358: Plla, HA Screw (2008), cited by 2
- K063726: PLC Suture Anchor (2007), cited by 1
- K093943: Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MM (2010), cited by 1

## Recent decisions
- K242631: REGENETEN™ Bioinductive Implant (Nov 26, 2024)
- K111843: Acufex Director Application Anatomic Guide System (Nov 14, 2011)
- K102544: Smith & Nephew Hip Arthroscopy Repair Instrument Tray (Jan 5, 2011)
- K092551: Smith & Nephew Instrument Trays (Sep 14, 2010)
- K100159: Smith and Nephew Twinfix Ultra TI Suture Anchor (Apr 19, 2010)
- K093943: Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MM (Mar 5, 2010)
- K093897: Smith & Nephew Footprint Ultra PK Suture Anchor (Mar 4, 2010)
- K073551: Smith & Nephew Instrument Trays (May 21, 2008)

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