Cleared Traditional

K212187 - Restoration? Modular Hip System
(FDA 510(k) Clearance)

K212187 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic

Mar 2022

Decision

231d

Days

Class 2

Risk

K212187 is an FDA 510(k) clearance for the Restoration? Modular Hip System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on March 1, 2022, 231 days after receiving the submission on July 13, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K212187 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2021
Decision Date	March 01, 2022
Days to Decision	231 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