510(k) Report

FDA applicant

Limacorporate

Villanova Di San Daniele Del Friuli, IT4 decisions2019–20250 recalls

FDA records 4 decisions for Limacorporate (Villanova Di San Daniele Del Friuli, IT) from 2019 to 2025: 4 510(k) clearances. 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 121 days from receipt to decision, against 126 for FDA’s reviews in the same codes and years. Its devices cite 10 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 Limacorporate’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12021: 12022: 12025: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Limacorporate 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?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…1decision
  • KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 121 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 126 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 20191cites it

What has FDA decided for it lately?

  • K243809Biolox® Delta Revision headsLimacorporate · 2025
  • K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate · 2022
  • K211938Physica LMC Knee SystemLimacorporate · 2021
  • K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019

All 4 as Limacorporate →