510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K926395Substantially Equivalent for Some Indications

Elite(tm) Zirconia Total Hip Ball Head System

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

K926395 is the FDA 510(k) clearance record for ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM, a class II device, cleared for Depuy, Inc. on under FDA product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented). FDA records list 220 510(k) clearances for Depuy, Inc., from to . As of , FDA records show no recalls naming K926395.

Clearance record

Decision date
Received
(444 days to decision)
Product code
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
Depuy, Inc. P.O. Box 988, Warsaw IN
Third party review
No

Clearances, product code LZO

Trailing 12 months
9 clearances under product code LZO in the twelve months to November 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LZO, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20262
April 20261
May 20260
June 20261
July 20261
August 20260
September 20262
October 20261
November 20260