# Fusion Orthopedics, LLC

- Location (FDA's records): Mesa, AZ
- FDA decisions: 13 (2016–2024): 13 510(k) clearances
- Names in FDA's records: Fusion Orthopedics, LLC (11); Fusion Orthopedics (2)
- Product codes: HWC (6), HRS (3), KWH (1), JDR (1), MBI (1), HTN (1)
- 510(k) review time since 2016: median 161 days, against 107 for FDA's reviews in the same codes and years (4 of 12 faster)
- Predicates its devices cite: 35 (5 its own); citations of its devices by later devices: 6 (5 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
- Trilliant Surgical, Ltd.: 5 (https://510kreport.com/company/trilliant-surgical)
- Wrightmedicaltechnologyinc: 3 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Arthrex, Inc.: 3 (https://510kreport.com/company/arthrex)
- Ortho-Pro, LLC: 2 (https://510kreport.com/company/ortho-pro)
- Osteomed LP: 2 (https://510kreport.com/company/osteomed)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Paragon 28, Inc.: 1 (https://510kreport.com/company/paragon-28)
- Extremity Medical, LLC: 1 (https://510kreport.com/company/extremity-medical)

## Firms that cite its devices most
- Nvision Biomedical Technologies, Inc.: 1 (https://510kreport.com/company/nvision-biomedical-technologies)

## Its most-cited devices
- K161449: HammerTech Fixation System (2016), cited by 2
- K202959: PolyLock Plating System (2020), cited by 1
- K192323: PolyLock Small Bone Plating System (2019), cited by 1
- K170038: FuzeFix Screw System (2017), cited by 1
- K182342: IntraLock Lapidus System (2019), cited by 1

## Recent decisions
- K242091: Bolo Button System (Dec 23, 2024)
- K211843: PolyLock Plating System (Mar 4, 2022)
- K210159: IntraLock System (Jul 23, 2021)
- K193377: TopLock Anchor System (Nov 25, 2020)
- K202959: PolyLock Plating System (Nov 24, 2020)
- K192323: PolyLock Small Bone Plating System (Nov 18, 2019)
- K190136: Fusion Silastic System (Oct 21, 2019)
- K182342: IntraLock Lapidus System (May 21, 2019)

Source page: https://510kreport.com/company/fusion-orthopedics