510(k) Report

FDA applicant

Optimotion Implants, LLC

Orlando, FL3 decisions2020–20240 recalls

FDA records 3 decisions for Optimotion Implants, LLC (Orlando, FL) from 2020 to 2024: 3 510(k) clearances. All are in product code MBH (Prosthesis, Knee, Patello/Femorotibial…). Since 2016 its 510(k)s took a median of 83 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 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 Optimotion Implants, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12022: 12024: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Optimotion Implants, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated…3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 83 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 84 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 20201cites it

What has FDA decided for it lately?

  • K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC · 2024
  • K220049Optimotion Implants Porous Metal-Backed PatellaOptimotion Implants, LLC · 2022
  • K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020

All 3 as Optimotion Implants, LLC →