Cleared Traditional

SHAPEMATCH CUTTING GUIDE

K122053 · Stryker Corp. · Orthopedic

Oct 2012

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K122053 is an FDA 510(k) clearance for the SHAPEMATCH CUTTING GUIDE, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Stryker Corp. (Alameda, US). The FDA issued a Cleared decision on October 24, 2012, 103 days after receiving the submission on July 13, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K122053 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2012
Decision Date	October 24, 2012
Days to Decision	103 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565