GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00— 510(k) K043346

Name: FDA 510(k) clearance K043346
Creator: U.S. Food and Drug Administration
Published: 2005-01-31

Substantially Equivalent

Genesis Medical LLC

FDA 510(k) clearance K043346 for GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00, Substantially Equivalent on 2005-01-31. Applicant: Genesis Medical LLC. Device class: 2.

Clearance details

Applicant: Genesis Medical LLC
Product code: Code KWS
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2004-12-06
Decision date: 2005-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWS

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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

Adverse events under product code KWS

product code KWS

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.