510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965002Substantially Equivalent

Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous Stems, the Encore Vitality Stems and Sl and

Encore Orthopedics, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965002 is the FDA 510(k) clearance record for ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND, a class II device, cleared for Encore Orthopedics, Inc. on under FDA product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented). FDA records list 85 510(k) clearances for Encore Orthopedics, Inc., from to . As of , FDA records show no recalls naming K965002.

Clearance record

Decision date
Received
(193 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
Encore Orthopedics, Inc. 8900 Shoal Creek Blvd.,, Austin TX
510(k) summary
Summary
Third party review
No

Clearances, product code LZO

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