FDA applicant

Unik Orthopedics, Inc.

San Jose, CA2 decisions2020–20240 recalls

FDA records 2 decisions for Unik Orthopedics, Inc. (San Jose, CA) from 2020 to 2024: 2 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and MBH (Prosthesis, Knee, Patello/Femorotibial…). Its devices cite 4 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 Unik Orthopedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

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

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

See the 510(k) Report

Other applicant names beginning “Unik”

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

Unik Products, Inc. 1

Unik Orthopedics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Unik”