510(k) Report

FDA applicant

Engage Uni, LLC

Winter Park, FL1 decision2019–20194 recalls

FDA records 1 decision for Engage Uni, LLC (Winter Park, FL) in 2019: 1 510(k) clearance. All are in product code NJD (Prosthesis, Knee, Femorotibial…). Its devices cite 1 predicate, 0 of them its own earlier devices. 4 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 Engage Uni, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

4in 2023

2023: 4
2019high 4 (2023) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Engage Uni, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated…1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K190439Engage™ Partial Knee SystemEngage Uni, LLC · 20192cite it

What has FDA decided for it lately?

  • K190439Engage™ Partial Knee SystemEngage Uni, LLC · 20194 recalls

The one decision as Engage Uni, LLC →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K190439Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a)…May 2, 2023Class II
  • K190439Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a)…May 2, 2023Class II
  • K190439Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part…May 2, 2023Class II
  • K190439Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers…May 2, 2023Class II