510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K912369Substantially Equivalent

Hap Bio-Groove Total Hip Prosthesis (Bio-Coat)

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

K912369 is the FDA 510(k) clearance record for HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT), a class II device, cleared for Biomet, Inc. on under FDA product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K912369.

Clearance record

Decision date
Received
(135 days to decision)
Product code
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. P.O. Box 587, Warsaw IN
510(k) summary
Statement
Third party review
No

Clearances, product code MEH

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