510(k) Report

FDA applicant

Overture Resurfacing, Inc.

New York, NY2 decisions2023–20230 recalls

FDA records 2 decisions for Overture Resurfacing, Inc. (New York, NY) in 2023: 2 510(k) clearances. Most are in product codes KRR (Prosthesis, Knee, Patello/Femoral…) and HSX (Prosthesis, Knee, Femorotibial…). 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 Overture Resurfacing, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2023: 2
2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Overture Resurfacing, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Overture”

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