510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915596Substantially Equivalent for Some Indications

Biomodular Shoulder Humeral Head W/ Ionguard

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

K915596 is the FDA 510(k) clearance record for BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD, a class II device, cleared for Biomet, Inc. on under FDA product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K915596.

Clearance record

Decision date
Received
(89 days to decision)
Product code
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Regulation
21 CFR 888.3650
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. P.O. Box 587, Warsaw IN
Third party review
No

Clearances, product code KWT

Trailing 12 months
2 clearances under product code KWT in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWT, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260