Cleared Traditional

Triathlon Tritanium Cone Augments

K143393 · Stryker Orthopaedics · Orthopedic

Jan 2015

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K143393 is an FDA 510(k) clearance for the Triathlon Tritanium Cone Augments, 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 January 13, 2015, 48 days after receiving the submission on November 26, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K143393 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 2014
Decision Date	January 13, 2015
Days to Decision	48 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