510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960363Substantially Equivalent

Bipolar Shoulder Prosthesis-Shell(rd-113130/33, Biangular Modular Head(rd-113101/41/42,Biomodular Modular Head(rd-113143

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960363 is the FDA 510(k) clearance record for BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143, a class III device, cleared for Biomet, Inc. on under FDA product code MJT (Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K960363.

Clearance record

Decision date
Received
(390 days to decision)
Product code
MJT Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
Device class
Class III
Review panel
Unknown
Applicant
Biomet, Inc. Airport Industrial Park, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code MJT

Trailing 12 months

FDA records hold no clearances under product code MJT in the trailing twelve months.

FDA records show no clearances under product code MJT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MJT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260