Cleared Traditional

K201219 - Biocore9 Femoral Head Resurfacing Component

K201219 is an FDA 510(k) clearance for Biocore9 Femoral Head Resurfacing Component, manufactured by Biocore9, LLC. The device is a Class 2 Orthopedic device with product code KXA cleared through the Traditional 510(k) pathway after a 258-day FDA review.

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

K201219 is an FDA 510(k) clearance for the Biocore9 Femoral Head Resurfacing Component. Classified as Prosthesis, Hip, Femoral, Resurfacing (product code KXA), Class II - Special Controls.

Submitted by Biocore9, LLC (Whippany, US). The FDA issued a Cleared decision on January 19, 2021 after a review of 258 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3400 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biocore9, LLC devices

FDA 510(k) Submission Details - K201219

510(k) Number K201219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 122d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXA Device Classification - Class 2, Special Controls

Product Code KXA Prosthesis, Hip, Femoral, Resurfacing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KXA Prosthesis, Hip, Femoral, Resurfacing

All 17
Devices cleared under the same product code (KXA) and FDA review panel - the closest regulatory comparables to K201219.
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