510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K955563Substantially Equivalent for Some Indications

Foundation Forged, Textured & Porous Stems W/biolox Ceramic Heads

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

K955563 is the FDA 510(k) clearance record for FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS, a class II device, cleared for Encore Orthopedics, Inc. on under FDA product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented). FDA records list 85 510(k) clearances for Encore Orthopedics, Inc., from to . As of , FDA records show no recalls naming K955563.

Clearance record

Decision date
Received
(247 days to decision)
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation
21 CFR 888.3358
Device class
Class II
Review panel
Orthopedic
Applicant
Encore Orthopedics, Inc. 8900 Shoal Creek Blvd.,, Austin TX
Third party review
No

Clearances, product code LPH

Trailing 12 months
9 clearances under product code LPH in the twelve months to November 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LPH, trailing twelve months
MonthClearances
December 20251
January 20261
February 20261
March 20260
April 20260
May 20261
June 20261
July 20261
August 20262
September 20261
October 20260
November 20260