GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID— 510(k) K092122

Name: FDA 510(k) clearance K092122
Creator: U.S. Food and Drug Administration
Published: 2009-07-27

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K092122 for GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID, Substantially Equivalent on 2009-07-27. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code KWS
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2009-07-14
Decision date: 2009-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K241292 — MyShoulder Planner (5.3SSWPL)2025-01-30

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K210167 — DELTA XTEND Reverse Shoulder System2021-02-19
K203167 — DePuy Corail AMT Hip Prosthesis2020-11-19

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.