Cleared Traditional

TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE

K101072 · Howmedica Osteonics Corp. · Orthopedic

Apr 2011

Decision

357d

Days

Class 2

Risk

About This 510(k) Submission

K101072 is an FDA 510(k) clearance for the TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on April 11, 2011, 357 days after receiving the submission on April 19, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K101072 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2010
Decision Date	April 11, 2011
Days to Decision	357 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358