510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K043100Substantially Equivalent

Bio-Modular Shoulder System with Hydroxyapatite (Ha) Coated Glenoid Components

Zimmer GmbH, Warsaw IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043100 is the FDA 510(k) clearance record for BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS, a class II device, cleared for Biomet, Inc. on under FDA product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show one recall naming K043100.

Clearance record

Decision date
Received
(100 days to decision)
Product code
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Regulation
21 CFR 888.3670
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. 56 E. Bell Dr., Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBF

Trailing 12 months
1 clearance under product code MBF in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MBF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260