KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM— 510(k) K940537

Clearance details

Applicant

Kirschner Medical Corp.

Product code

Code KWT

Device class

Class 2

Regulation

21 CFR 888.3650

Advisory panel

Orthopedic

Date received

1994-02-07

Decision date

1995-08-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fair Lawn, NJ, US

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• K241944 — AGILON® XO Shoulder Replacement System2025-03-10
• K241817 — InSet Total Shoulder System2025-02-11

• 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
• K935951 — KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM1994-07-18

Injury

2,467

Other

2

Total

2,469

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 →