Cleared Traditional

TRIATHLON TRITANIUM METAL-BACKED PATELLA

K132624 · Stryker Orthopaedics · Orthopedic

Nov 2013

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K132624 is an FDA 510(k) clearance for the TRIATHLON TRITANIUM METAL-BACKED PATELLA, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on November 26, 2013, 96 days after receiving the submission on August 22, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K132624 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 2013
Decision Date	November 26, 2013
Days to Decision	96 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