510(k) Report

FDA applicant

Exactech Sarasota

Gainesville, FL2 decisions2011–20140 recalls

FDA records 2 decisions for Exactech Sarasota (Gainesville, FL) from 2011 to 2014: 2 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and KWP (Appliance, Fixation, Spinal Interlaminal). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is 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 Sarasota’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12014: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Exactech Sarasota by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1decision
  • KWPAppliance, Fixation, Spinal Interlaminal1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K110547Optertrak Logic PSC Tibial InsertExactech Sarasota · 20112cite it
  • K140645Gibralt Rod-to-Rod Cross ConnectorsExactech Sarasota · 20141cites it

What has FDA decided for it lately?

  • K140645Gibralt Rod-to-Rod Cross ConnectorsExactech Sarasota · 2014
  • K110547Optertrak Logic PSC Tibial InsertExactech Sarasota · 2011

All 2 as Exactech Sarasota →

Other applicant names beginning “Exactech”

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

Exactech, Inc. 187