# Exactech, Inc.

- Location (FDA's records): Gainesville, FL
- FDA decisions: 187 (1986–2026): 186 510(k) clearances and 1 original PMA approval
- Product codes: JWH (32), LZO (21), PHX (21), LPH (19), JDI (12), MEH (8), KWS (8), LOD (5), MBH (5), HSD (4), KWT (4), HSN (4)
- 510(k) review time since 2016: median 159 days, against 121 for FDA's reviews in the same codes and years (13 of 36 faster)
- Predicates its devices cite: 406 (241 its own); citations of its devices by later devices: 354 (241 its own)
- Recalls linked to its devices: 182 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tornier, Inc.: 17 (https://510kreport.com/company/tornier)
- DePuy Orthopaedics, Inc.: 15 (https://510kreport.com/company/depuy-orthopaedics)
- Zimmer, Inc.: 9 (https://510kreport.com/company/zimmer)
- Biomet, Inc.: 8 (https://510kreport.com/company/biomet)
- Musculoskeletal Transplant Foundation: 8 (https://510kreport.com/company/musculoskeletal-transplant-foundation)
- Biomet Manufacturing Corp: 5 (https://510kreport.com/company/biomet-manufacturing)
- Wrightmedicaltechnologyinc: 4 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Ldr Spine USA: 4 (https://510kreport.com/company/ldr-spine-usa)

## Firms that cite its devices most
- Encore Medical L.P.: 9 (https://510kreport.com/company/encore-medical)
- Fournitures Hospitalieres Industrie: 8 (https://510kreport.com/company/fournitures-hospitalieres-industrie)
- Biomet, Inc.: 7 (https://510kreport.com/company/biomet)
- Tecres S.P.A.: 7 (https://510kreport.com/company/tecres)
- Choice Spine, LLC: 6 (https://510kreport.com/company/choice-spine)
- Medacta International S.A.: 4 (https://510kreport.com/company/medacta-international)
- Biomet Manufacturing Corp: 4 (https://510kreport.com/company/biomet-manufacturing)
- Osteotech, Inc.: 4 (https://510kreport.com/company/osteotech)

## Its most-cited devices
- K063569: Equinoxe Reverse Shoulder System (2007), cited by 16
- K042021: Exactech Equinoxe Shoulder System (2004), cited by 14
- K933610: Exactech Cemented Total Knee System, Tibial Components (1995), cited by 10
- K993082: Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component (1999), cited by 9
- K020078: Exactech Resorbable Bone Paste (2004), cited by 8
- K041906: Exactech 12/14 Total Hip System (2004), cited by 7

## Recent decisions
- K260583: Equinoxe® Shoulder System (Apr 14, 2026)
- K250713: Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants (Dec 1, 2025)
- K243448: Equinoxe® Shoulder System (Aug 1, 2025)
- K243275: Equinoxe® Scapula Fracture System (Jun 26, 2025)
- K243839: Alteon® HA Femoral Stems (Mar 10, 2025)
- K240393: Exactech® TRULIANT® Knee System (Oct 3, 2024)
- K233482: Equinoxe® Central Screw Baseplate System (Jul 18, 2024)
- K230717: Exactech® Vantage® Total Ankle System (Oct 12, 2023)

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