Cleared Traditional

STRYKER PATIENT SPECIFIC CUTTING GUIDE

K110533 · Stryker Corp. · Orthopedic

May 2011

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K110533 is an FDA 510(k) clearance for the STRYKER PATIENT SPECIFIC 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. (Malwah, US). The FDA issued a Cleared decision on May 19, 2011, 84 days after receiving the submission on February 24, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K110533 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2011
Decision Date	May 19, 2011
Days to Decision	84 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