510(k) Report

FDA applicant

Kirschner Medical Corp.

Timonium, MD76 decisions1983–199515 recalls

FDA records 76 decisions for Kirschner Medical Corp. (Timonium, MD) from 1983 to 1995: 76 510(k) clearances. Most are in product codes JDI (Prosthesis, Hip, Semi-Constrained…) and JWH (Prosthesis, Knee, Patellofemorotibial…). 15 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 Kirschner Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kirschner Medical Corp. since 2007.

Recalls per year

13in 2018

2016: 22018: 13
2007high 13 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Kirschner Medical Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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