510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921139Substantially Equivalent

Healey Revision Component System

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

K921139 is the FDA 510(k) clearance record for HEALEY REVISION COMPONENT SYSTEM, a class III device, cleared for Biomet, Inc. on under FDA product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K921139.

Clearance record

Decision date
Received
(113 days to decision)
Product code
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Regulation
21 CFR 888.3320
Device class
Class III
Review panel
Orthopedic
Applicant
Biomet, Inc. P.O. Box 587, Warsaw IN
510(k) summary
Statement
Third party review
No

Clearances, product code JDL

Trailing 12 months

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

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