# Wrightmedicaltechnologyinc

- Location (FDA's records): Arlington, TN
- FDA decisions: 303 (1993–2023): 302 510(k) clearances and 1 original PMA approval
- Product codes: HRS (45), HWC (31), MQV (28), KWA (26), HSN (21), JWH (20), LPH (12), MBI (11), KTT (11), JDI (11), LZO (11), MBH (8)
- 510(k) review time since 2016: median 131 days, against 111 for FDA's reviews in the same codes and years (16 of 36 faster)
- Predicates its devices cite: 334 (255 its own); citations of its devices by later devices: 757 (255 its own)
- Recalls linked to its devices: 115 (14 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smith & Nephew, Inc.: 6 (https://510kreport.com/company/smith-nephew)
- Darco International, Inc.: 6 (https://510kreport.com/company/darco-international)
- Topez Orthopedics, Inc.: 5 (https://510kreport.com/company/topez-orthopedics)
- Synthes (Usa): 5 (https://510kreport.com/company/synthes-usa)
- DePuy Orthopaedics, Inc.: 5 (https://510kreport.com/company/depuy-orthopaedics)
- New Deal, S.A.: 5 (https://510kreport.com/company/new-deal)
- Dow Corning Wright: 4 (https://510kreport.com/company/dow-corning-wright)
- Ortho-Pro, LLC: 3 (https://510kreport.com/company/ortho-pro)

## Firms that cite its devices most
- Microport Orthopedics, Inc.: 82 (https://510kreport.com/company/microport-orthopedics)
- Microport Orthopedics Inc. (Mpo): 31 (https://510kreport.com/company/microport-orthopedics-mpo)
- Medline Industries, Inc.: 11 (https://510kreport.com/company/medline-industries)
- Paragon 28, Inc.: 10 (https://510kreport.com/company/paragon-28)
- In2bones USA, LLC: 10 (https://510kreport.com/company/in2bones-usa)
- Arthrex, Inc.: 9 (https://510kreport.com/company/arthrex)
- Newclip Technics: 8 (https://510kreport.com/company/newclip-technics)
- Biomet, Inc.: 8 (https://510kreport.com/company/biomet)

## Its most-cited devices
- K082320: Darco Small Screw (2008), cited by 18
- K093552: Evolution MP Total Knee System (2010), cited by 15
- K101165: Pro-Toe VO Hammertow Implant System (2010), cited by 14
- K121651: Ortholoc 3DI Midfoot/Flatfoot System (2012), cited by 13
- K021346: Stem Hip Replacement System, Model PHA002XX (2002), cited by 11
- K120359: Ortholoc 3DI Hallux System (2012), cited by 11

## Recent decisions
- K222835: Prophecy Preoperative Navigation Alignment System (Jan 27, 2023)
- K213342: PRO-DENSE LoVisc Bone Graft Substitute (Jan 5, 2022)
- K212996: Sterile PHALINX Hammertoe System (Nov 16, 2021)
- K202815: PROPHECY Preoperative Navigation Alignment System (Mar 10, 2021)
- K201259: ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System (Jan 8, 2021)
- K200507: PRO-DENSE LoVisc Bone Graft Substitute (Oct 21, 2020)
- K193067: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System (Jun 8, 2020)
- K191393: INFINITY Total Ankle System, INBONE Total Ankle System (Aug 22, 2019)

Source page: https://510kreport.com/company/wrightmedicaltechnologyinc