Biocore9 Femoral Head Resurfacing Component

FDA 510(k) K201219 · Biocore9, LLC

Substantially Equivalent

510(k) numberK201219

Submission

Device name
Biocore9 Femoral Head Resurfacing Component
Applicant
Biocore9, LLC
Whippany, NJ, US
Received
May 6, 2020
Decision date
January 19, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KXA – Prosthesis, Hip, Femoral, Resurfacing
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3400
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code KXA

510(k)DeviceApplicantDecision
K092198Cormet Cementless Resurfacing Femoral HeadKXA · Traditional Corin USA04/15/2010SE
K082673Conserve Pressfit Femoral ComponentKXA · Traditional Wrightmedicaltechnologyinc12/12/2008SE
K071053Recap Ha Press-Fit Femoral Resurfacing HeadKXA · Special Biomet, Inc.06/29/2007SE
K070292Durom Hip Resurfacing System, Femoral ComponentsKXA · Traditional Zimmer GmbH04/26/2007SE
K062960Conserve Femoral Resurfacing ComponentKXA · Special Wrightmedicaltechnologyinc12/01/2006SE
K043542Biopro Tara Femoral Resurfacing ComponentKXA · Traditional Biopro, Inc.05/18/2005SE
K032659Depuy Asr Resurfacing Femoral HeadsKXA · Traditional DePuy Orthopaedics, Inc.12/04/2003SE
K023188Press-Fit Head Resurfacing DeviceKXA · Traditional Biomet Orthopedics, Inc.12/11/2002SE
K021549Contoured Articular Prosthesis (Cap) Femoral Head Resurfacing SystemKXA · Traditional Std Mfg., Inc.08/01/2002SE
K021799Cemented Femoral Head Resurfing DeviceKXA · Special Biomet Orthopedics, Inc.06/26/2002SE

More from Biomet Orthopedics, Inc.

510(k)DeviceDecision
K212761Biocore9 Acetabular Cup SystemLPH · Traditional 05/17/2022SE
K193122Biocore9 Humeral Resurfacing SystemHSD · Traditional 05/15/2020SE

Questions and answers

When was Biocore9 Femoral Head Resurfacing Component cleared by the FDA?

Biocore9 Femoral Head Resurfacing Component (K201219) received a 510(k) decision of Substantially Equivalent on January 19, 2021, 258 days after the submission was received.

What is the product code of K201219?

The FDA product code is KXA – Prosthesis, Hip, Femoral, Resurfacing, a Class II (moderate risk) device regulated under 21 CFR 888.3400.