Cleared Traditional

PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD

K061564 · Portland Orthopaedics Pty. , Ltd. · Orthopedic

Sep 2006

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K061564 is an FDA 510(k) clearance for the PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Portland Orthopaedics Pty. , Ltd. (Stillwater, US). The FDA issued a Cleared decision on September 1, 2006, 88 days after receiving the submission on June 5, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K061564 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 2006
Decision Date	September 01, 2006
Days to Decision	88 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