AVENIR MULLER STEM— 510(k) K123392

Clearance details

Applicant

Zimmer GmbH

Product code

Code LZO

Device class

Class 2

Regulation

21 CFR 888.3353

Advisory panel

Orthopedic

Date received

2012-11-02

Decision date

2013-03-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• 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
• 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

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-0644-2019 — Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with an adequate bone stock to support the component. A system consisting of a stem, a ball head and a cup is used for the treatment of degenerative diseases or trauma of the hip. All Avenir Muller Stems are intended to provide connection to articulation with specified ball heads through the 12/14 taper. The stems may be used for total hip and hemi-hip arthroplasty. During total hip arthroplasty, the stems may be combined with constrained or semi-constrained acetabular systems.Class II·Terminated·Zimmer GmbH·20181031
• Z-1524-2018 — Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368Class II·Terminated·Zimmer GmbH·20180228
• Z-1525-2018 — Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496Class II·Terminated·Zimmer GmbH·20180228
• Z-2292-2016 — Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). " Acute traumatic fracture of the femoral head or neck " Avascular necrosis of the femoral head. " Avenir Moller Stems are for cementless use only.Class II·Terminated·Zimmer Gmbh·20160630

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123392.