BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS— 510(k) K043100

Clearance details

Applicant

Biomet, Inc.

Product code

Code MBF

Device class

Class 2

Regulation

21 CFR 888.3670

Advisory panel

Orthopedic

Date received

2004-11-09

Decision date

2005-02-17

Decision

Substantially Equivalent

Clearance type

Special

Location

Warsaw, IN, US

• K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)2026-04-13
• K251098 — Identity Revision Humeral Stems2025-08-11
• K250848 — Identity Shoulder System2025-07-02
• K240876 — Identity Shoulder System2024-06-12
• K233712 — PRIMA Humeral System; PRIMA TT Glenoid2024-01-11

• K253434 — OSSTM Orthopedic Salvage System2026-07-01
• K251270 — Taperloc® Complete Hip Stem2026-05-19
• K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
• K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
• K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

Injury

597

Total

597

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-0533-2020 — BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder ReplacementClass II·Terminated·Zimmer Biomet, Inc.·20190821

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043100.