MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM— 510(k) K081620

Name: FDA 510(k) clearance K081620
Creator: U.S. Food and Drug Administration
Published: 2008-06-30

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K081620 for MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM, Substantially Equivalent on 2008-06-30. 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: 2008-06-09
Decision date: 2008-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWS

view all

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

More clearances from DePuy Orthopaedics, Inc.

view all

K252887 — DePuy ATTUNE Knee System2026-05-22
K231503 — CUPTIMIZE Advanced2023-08-22
K213839 — DePuy Corail AMT Hip Prosthesis2022-01-06
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.