Cleared Traditional

Triathlon? X3? UHMWPE Tibial Inserts and Patellar Components

K172634 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Orthopedic

Nov 2017

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K172634 is an FDA 510(k) clearance for the Triathlon? X3? UHMWPE Tibial Inserts and Patellar Components, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on November 16, 2017, 76 days after receiving the submission on September 1, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K172634 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 01, 2017
Decision Date	November 16, 2017
Days to Decision	76 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