Cleared Traditional

Restoration Anatomic Shell

K151264 · Stryker Orthopaedics · Orthopedic

Aug 2015

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K151264 is an FDA 510(k) clearance for the Restoration Anatomic Shell, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on August 10, 2015, 89 days after receiving the submission on May 13, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K151264 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 2015
Decision Date	August 10, 2015
Days to Decision	89 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