Cleared Traditional

Biocore9 Femoral Head Resurfacing Component

K201219 · Biocore9, LLC · Orthopedic
Jan 2021
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K201219 is an FDA 510(k) clearance for the Biocore9 Femoral Head Resurfacing Component, a Prosthesis, Hip, Femoral, Resurfacing (Class II — Special Controls, product code KXA), submitted by Biocore9, LLC (Whippany, US). The FDA issued a Cleared decision on January 19, 2021, 258 days after receiving the submission on May 6, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3400.

Submission Details

510(k) Number K201219 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2020
Decision Date January 19, 2021
Days to Decision 258 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KXA — Prosthesis, Hip, Femoral, Resurfacing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3400

Similar Devices — KXA Prosthesis, Hip, Femoral, Resurfacing

All 22
CORMET CEMENTLESS RESURFACING FEMORAL HEAD
K092198 · Corin USA · Apr 2010
CONSERVE PRESSFIT FEMORAL COMPONENT
K082673 · Wrightmedicaltechnologyinc · Dec 2008
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
K071053 · Biomet, Inc. · Jun 2007
DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
K070292 · Zimmer GmbH · Apr 2007
CONSERVE FEMORAL RESURFACING COMPONENT
K062960 · Wrightmedicaltechnologyinc · Dec 2006
BIOPRO TARA FEMORAL RESURFACING COMPONENT
K043542 · Biopro, Inc. · May 2005