# Biopro, Inc.

- Location (FDA's records): Port Huron, MI
- FDA decisions: 41 (1987–2017): 41 510(k) clearances
- Product codes: JDI (7), HWC (3), KWD (3), LZO (3), HRS (3), JDR (2), KXA (2), HSB (2), KYI (2), KWY (2), JWH (2), KWL (2)
- Predicates its devices cite: 48 (3 its own); citations of its devices by later devices: 51 (3 its own)
- Recalls linked to its devices: 33 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 8 (https://510kreport.com/company/synthes-usa)
- Medartis AG: 3 (https://510kreport.com/company/medartis)
- Wrightmedicaltechnologyinc: 3 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Millennium Medical Technologies, Inc.: 2 (https://510kreport.com/company/millennium-medical-technologies)
- Kinetikos Medical, Inc.: 2 (https://510kreport.com/company/kinetikos-medical)
- Ortho Solutions Limited: 2 (https://510kreport.com/company/ortho-solutions)
- Stryker Trauma AG: 2 (https://510kreport.com/company/stryker-trauma)
- DePuy Orthopaedics, Inc.: 1 (https://510kreport.com/company/depuy-orthopaedics)

## Firms that cite its devices most
- Theken Companies, LLC: 4 (https://510kreport.com/company/theken-companies)
- Biomet, Inc.: 4 (https://510kreport.com/company/biomet)
- Tyber Medical, LLC: 4 (https://510kreport.com/company/tyber-medical)
- Nvision Biomedical Technologies, Inc.: 2 (https://510kreport.com/company/nvision-biomedical-technologies)
- Osteomed LP: 2 (https://510kreport.com/company/osteomed)
- Wishbone Medical, Inc.: 2 (https://510kreport.com/company/wishbone-medical)
- Ortho Solutions Limited: 2 (https://510kreport.com/company/ortho-solutions)
- Agent Medical, LLC: 2 (https://510kreport.com/company/agent-medical)

## Its most-cited devices
- K041595: Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 (2004), cited by 7
- K904448: Townley Total Knee (TTK) (1991), cited by 6
- K911378: Townley Great Toe Joint (1991), cited by 5
- K081149: Biopro GO-EZ Screw (2008), cited by 5
- K061798: Biopro Memory Staple (2006), cited by 4
- K082705: Biopro Bipolar Head, Models 18130-18152 (2008), cited by 4

## Recent decisions
- K163627: Shotel Ankle Arthrodesis Nail System (Sep 14, 2017)
- K162674: BioPro Foot Plating Systems (Jun 16, 2017)
- K132510: Biopro - Infinity Plate Anchor System (Oct 24, 2013)
- K130298: Biopro Kwick-Wire Universal Screw System (Jun 18, 2013)
- K121973: Biopro Hemi-Edge Toe System (Oct 30, 2012)
- K100761: Biopro Polar Head (Dec 3, 2010)
- K101030: Modification to HBS Headless Bone Screw (Jun 3, 2010)
- K090208: Biopro Femoral Heads (May 22, 2009)

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