510(k) Report

FDA applicant

Exactech, Inc.

Gainesville, FL187 decisions1986–2026182 recalls

FDA records 187 decisions for Exactech, Inc. (Gainesville, FL) from 1986 to 2026: 186 510(k) clearances and 1 original PMA approval. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and LZO (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 159 days from receipt to decision, against 121 for FDA’s reviews in the same codes and years. Its devices cite 406 predicates, 241 of them its own earlier devices. 182 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Exactech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2007: 62008: 52009: 12010: 142011: 102012: 82013: 82014: 82015: 92016: 62017: 62018: 82019: 42020: 22022: 12023: 62024: 22025: 42026 (partial year): 1
2007high 14 (2010) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

5in 2025

2007: 12011: 32012: 82013: 22014: 22015: 42016: 122017: 402018: 42019: 32020: 92021: 302022: 102023: 112024: 322025: 5
2007high 40 (2017) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Exactech, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Exactech, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer32decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…21decisions
  • PHXShoulder Prosthesis, Reverse Configuration21decisions
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented19decisions
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented12decisions
  • MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium…8decisions

Also: KWS (8), LOD (5), MBH (5), HSD (4), KWT (4), HSN (4).

How long do its 510(k) reviews take?

Since 2016, its 36 510(k)s took a median of 159 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 121 days; 13 of its 36 were faster than that.

Whose devices does it build on?

Its devices cite 406 predicates; 241 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 354 times; 241 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K063569Equinoxe Reverse Shoulder SystemExactech, Inc. · 200716cite it
  • K042021Exactech Equinoxe Shoulder SystemExactech, Inc. · 200414cite it
  • K933610Exactech Cemented Total Knee System, Tibial ComponentsExactech, Inc. · 199510cite it
  • K993082Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentExactech, Inc. · 19999cite it
  • K020078Exactech Resorbable Bone PasteExactech, Inc. · 20048cite it
  • K041906Exactech 12/14 Total Hip SystemExactech, Inc. · 20047cite it

What has FDA decided for it lately?

  • K260583Equinoxe® Shoulder SystemExactech, Inc. · 2026
  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K243448Equinoxe® Shoulder SystemExactech, Inc. · 2025
  • K243275Equinoxe® Scapula Fracture SystemExactech, Inc. · 2025
  • K243839Alteon® HA Femoral StemsExactech, Inc. · 2025
  • K240393Exactech® TRULIANT® Knee SystemExactech, Inc. · 2024
  • K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc. · 2024
  • K230717Exactech® Vantage® Total Ankle SystemExactech, Inc. · 2023

All 187 as Exactech, Inc. →

What has been recalled?

182 recalls linked to its devices; the latest:

  • K042021Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog…Sep 5, 2025Class II
  • K042021Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog…Sep 5, 2025Class II
  • K042021Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog…Sep 5, 2025Class II
  • K223833Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER…Aug 15, 2025Class II
  • K063569Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM…Aug 15, 2025Class II
  • K173583Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM…Dec 31, 2024Class II

Other applicant names beginning “Exactech”

FDA records each applicant name separately; these may or may not be the same firm.

Exactech Sarasota 2