DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS— 510(k) K053536

Clearance details

Applicant

Zimmer GmbH

Product code

Code KWA

Device class

Class 3

Regulation

21 CFR 888.3330

Advisory panel

Orthopedic

Date received

2005-12-19

Decision date

2006-03-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K122778 — PROFEMUR Z REVISION HIP STEM2012-10-11
• K121544 — DYNASTY BIOFOAM SHELL2012-07-30
• K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS2012-05-18
• K113322 — CONSERVE THIN SHELL2012-02-03
• K112080 — PRESERVE HIP STEM2011-12-28

• K211047 — CoCr Head2023-01-10
• K200814 — Affixus(R) Natural Nail(R) System Humeral Nail2020-04-28
• K200112 — Zimmer Hip Joint Replacement2020-04-10
• K193099 — Anatomical Shoulder System2020-01-29
• K193050 — Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem2019-12-26

Death

38

Injury

10,439

Malfunction

1,862

Total

12,339

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-0248-2013 — Kopf Adapter S Sterile, RxClass II·Terminated·Zimmer, Inc.·20120904

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053536.