Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System— 510(k) K142403

Clearance details

Applicant

Zimmer GmbH

Product code

Code KWS

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2014-08-27

Decision date

2014-11-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Winterthur, CH

• K260721 — Tornier Perform Advanced Glenoid2026-07-22
• K254084 — AETOS Shoulder System - CONCELOC Glenoids2026-04-06
• K252418 — Catalyst F1x Shoulder System2025-11-06
• K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 02025-10-29
• K241292 — MyShoulder Planner (5.3SSWPL)2025-01-30

• K211047 — CoCr Head2023-01-10
• K200814 — Affixus(R) Natural Nail(R) System Humeral Nail2020-04-28
• K200112 — Zimmer Hip Joint Replacement2020-04-10
• K193099 — Anatomical Shoulder System2020-01-29
• K193050 — Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem2019-12-26

Death

6

Injury

9,652

Malfunction

1,385

Other

1

Total

11,044

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 →

• Z-2003-2016 — Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.Class II·Terminated·Zimmer Gmbh·20160517

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142403.