# Paragon 28, Inc.

- Location (FDA's records): Englewood, CO
- FDA decisions: 61 (2014–2026): 61 510(k) clearances
- Names in FDA's records: Paragon 28, Inc. (54); Paragon 28 (7)
- Product codes: MBI (13), HSB (8), HSN (8), HWC (8), HRS (8), KTT (6), JDR (4), HTY (3), PLF (2), KTW (1)
- 510(k) review time since 2016: median 72 days, against 94 for FDA's reviews in the same codes and years (31 of 51 faster)
- Predicates its devices cite: 126 (60 its own); citations of its devices by later devices: 94 (60 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wrightmedicaltechnologyinc: 10 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Arthrex, Inc.: 9 (https://510kreport.com/company/arthrex)
- Osteomedics, Inc.: 3 (https://510kreport.com/company/osteomedics)
- Orthohelix Surgical Designs, Inc.: 3 (https://510kreport.com/company/orthohelix-surgical-designs)
- Vilex, LLC: 2 (https://510kreport.com/company/vilex)
- Orthofix, Inc.: 2 (https://510kreport.com/company/orthofix)
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- Apogee Orthosolutions: 2 (https://510kreport.com/company/apogee-orthosolutions)

## Firms that cite its devices most
- Extremity Medical, LLC: 5 (https://510kreport.com/company/extremity-medical)
- Vilex, LLC: 4 (https://510kreport.com/company/vilex)
- Pace Surgical: 3 (https://510kreport.com/company/pace-surgical)
- Nvision Biomedical Technologies, Inc.: 2 (https://510kreport.com/company/nvision-biomedical-technologies)
- Armis Biopharma, Inc.: 1 (https://510kreport.com/company/armis-biopharma)
- Newclip Technics: 1 (https://510kreport.com/company/newclip-technics)
- Nextremity Solutions, Inc.: 1 (https://510kreport.com/company/nextremity-solutions)
- Additive Orthopaedics, LLC: 1 (https://510kreport.com/company/additive-orthopaedics)

## Its most-cited devices
- K140397: Paralock Plating System / Tuffnek Screw (2014), cited by 7
- K211002: Grappler Suture Anchor System (2021), cited by 6
- K203011: Monster Screw System (2020), cited by 6
- K190365: Baby Gorilla/Gorilla Plating System (2019), cited by 6
- K190586: Monster® Screw System (2019), cited by 6
- K203511: Baby Gorilla/Gorilla Plating System (2020), cited by 6

## Recent decisions
- K261120: APEX 3D S Diamond Tibia (Oct 7, 2026)
- K262722: Primal K-Wire (P99-193-1410) (Aug 28, 2026)
- K261121: Megalodon Dynamic Compression System (Aug 6, 2026)
- K262047: Grappler Suture Anchor System (Aug 3, 2026)
- K253886: Grappler Suture Anchor PCFD Tether System (Mar 17, 2026)
- K253591: Phantom® Hindfoot TTC/TC Nail System (Mar 5, 2026)
- K253613: Monkey Rings External Ring Fixation System (Dec 19, 2025)
- K252106: External Fixation Mini Rail System (Sep 30, 2025)

Source page: https://510kreport.com/company/paragon-28