Cleared Traditional

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem

K220731 · Stryker · Orthopedic

Aug 2022

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K220731 is an FDA 510(k) clearance for the Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Stryker (Malwah, US). The FDA issued a Cleared decision on August 11, 2022, 150 days after receiving the submission on March 14, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K220731 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2022
Decision Date	August 11, 2022
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353