Cleared Traditional

TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS

K141056 · Stryker Orthopaedics · Orthopedic

Aug 2014

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K141056 is an FDA 510(k) clearance for the TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS, 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 August 5, 2014, 103 days after receiving the submission on April 24, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K141056 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2014
Decision Date	August 05, 2014
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