Cleared Traditional

DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE

K122015 · Howmedica Osteonics Corp. · Orthopedic
Feb 2013
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K122015 is an FDA 510(k) clearance for the DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on February 22, 2013, 227 days after receiving the submission on July 10, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K122015 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2012
Decision Date February 22, 2013
Days to Decision 227 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3510

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