Cleared Traditional

HIPSTAR FEMORAL STEM

K051223 · Stryker Orthopaedics · Orthopedic

May 2006

Decision

363d

Days

Class 2

Risk

About This 510(k) Submission

K051223 is an FDA 510(k) clearance for the HIPSTAR FEMORAL STEM, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on May 10, 2006, 363 days after receiving the submission on May 12, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K051223 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2005
Decision Date	May 10, 2006
Days to Decision	363 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