Cleared Traditional

Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite

K200782 · Howmedica Osteonics Corp. · Orthopedic

May 2020

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K200782 is an FDA 510(k) clearance for the Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite, 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. (Malwah, US). The FDA issued a Cleared decision on May 13, 2020, 48 days after receiving the submission on March 26, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K200782 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 2020
Decision Date	May 13, 2020
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