Zimmer Hip Joint Replacement— 510(k) K200112

Clearance details

Applicant

Zimmer GmbH

Product code

Code LZO

Device class

Class 2

Regulation

21 CFR 888.3353

Advisory panel

Orthopedic

Date received

2020-01-17

Decision date

2020-04-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Winterthur, CH

• K253948 — Momentum Acetabular Cup System2026-09-02
• K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various)2026-07-06
• K260831 — Z1 Hip System2026-06-16
• K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
• K260037 — implantcast Packaging System Update2026-03-30

• K211047 — CoCr Head2023-01-10
• K200814 — Affixus(R) Natural Nail(R) System Humeral Nail2020-04-28
• K193099 — Anatomical Shoulder System2020-01-29
• K193050 — Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem2019-12-26
• K193030 — Avenir Muller Stem, Avenir Cemented Hip Stem2019-12-06

Death

17

Injury

12,942

Malfunction

1,756

Total

14,715

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-0569-2024 — Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01Class II·Ongoing·Biomet, Inc.·20231102
• Z-0570-2024 — Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02Class II·Ongoing·Biomet, Inc.·20231102

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200112.