KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM— 510(k) K894068

Clearance details

Applicant

Kirschner Medical Corp.

Product code

Code HSX

Device class

Class 2

Regulation

21 CFR 888.3520

Advisory panel

Orthopedic

Date received

1989-06-08

Decision date

1989-12-08

Decision

Substantially Equivalent for Some Indications

Clearance type

Traditional

Location

Timonium, MD, US

• K261609 — Freedom Partial Knee System2026-08-04
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• K251771 — Cambridge Partial Knee2025-12-16
• K251834 — Persona Partial Knee2025-08-15
• K251618 — MOTO Partial Knee System Extension2025-07-24

• K940537 — KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM1995-08-29
• K936274 — KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM1995-01-18
• K942891 — SUMMIT TOTAL HIP SYSTEM1994-11-02
• K941486 — INTEGRITY TOTAL HIP SYSTEM, NON-POROUS1994-09-20
• K933843 — LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED1994-08-05

Injury

1,003

Other

1

Total

1,004

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →