DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT— 510(k) K061144

Clearance details

Applicant

DePuy Orthopaedics, Inc.

Product code

Code MBB

Device class

Class 2

Regulation

21 CFR 888.3027

Advisory panel

Orthopedic

Date received

2006-04-25

Decision date

2006-06-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

• 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

Death

27

Injury

1,412

Malfunction

551

Total

1,990

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 →