DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES— 510(k) K063633

Clearance details

Applicant

DePuy Orthopaedics, Inc.

Product code

Code JWH

Device class

Class 2

Regulation

21 CFR 888.3560

Advisory panel

Orthopedic

Date received

2006-12-06

Decision date

2007-03-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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

Death

26

Injury

51,564

Malfunction

9,725

Other

9

Total

61,324

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-1103-2021 — Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.Class II·Terminated·DePuy Orthopaedics, Inc.·20210108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063633.