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510(k) K940537

KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM by Kirschner Medical Corp. — Product Code KWT

K940537 is an FDA 510(k) premarket notification submitted by Kirschner Medical Corp. for the device "KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM". The FDA issued a decision of Substantially Equivalent on August 29, 1995. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Kirschner Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1995
Date Received
February 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3650
Review Panel
OR
Submission Type

Other clearances by Kirschner Medical Corp.

  • K936274 — KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM (January 18, 1995)
  • K942891 — SUMMIT TOTAL HIP SYSTEM (November 2, 1994)
  • K941486 — INTEGRITY TOTAL HIP SYSTEM, NON-POROUS (September 20, 1994)
  • K933843 — LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED (August 5, 1994)
  • K935951 — KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM (July 18, 1994)
  • K934589 — KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED (July 13, 1994)
  • K935206 — KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION (July 13, 1994)
  • K934694 — KIRSCHNER ZIRCONIA FEMORAL HEAD (May 18, 1994)
  • K920188 — THREADED PINS (May 12, 1993)
  • K921837 — MEDICAM 900 INSUFFLATOR WITH ACCESSORIES (February 5, 1993)

Other clearances for product code KWT

  • K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implant (December 1, 2025)
  • K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max) (October 30, 2025)
  • K241944 — AGILON® XO Shoulder Replacement System (March 10, 2025)
  • K241817 — InSet Total Shoulder System (February 11, 2025)
  • K231657 — AGILON® XO Shoulder Replacement System (February 16, 2024)
  • K223631 — Comprehensive Segmental Revision System(SRS) (July 12, 2023)
  • K222482 — AGILON XO Shoulder System (September 28, 2022)
  • K210899 — LINK Embrace Shoulder System- Anatomical Configuration (June 21, 2021)
  • K191698 — TiN Coated Humeral Head (July 16, 2020)
  • K192365 — Shoulder Innovations Total Shoulder System (November 29, 2019)

FDA data resources