Cleared Traditional

TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE

K072575 · Stryker Orthopaedics · Orthopedic

Jan 2008

Decision

116d

Days

Class 2

Risk

About This 510(k) Submission

K072575 is an FDA 510(k) clearance for the TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE, 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 7, 2008, 116 days after receiving the submission on September 13, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K072575 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2007
Decision Date	January 07, 2008
Days to Decision	116 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