Cleared Traditional

ceramys? femoral head system

K241483 · Encore Medical, L.P. · Orthopedic

Feb 2025

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K241483 is an FDA 510(k) clearance for the ceramys? femoral head system, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on February 7, 2025, 259 days after receiving the submission on May 24, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K241483 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2024
Decision Date	February 07, 2025
Days to Decision	259 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353