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510(k) K201219

Biocore9 Femoral Head Resurfacing Component by Biocore9, LLC — Product Code KXA

K201219 is an FDA 510(k) premarket notification submitted by Biocore9, LLC for the device "Biocore9 Femoral Head Resurfacing Component". The FDA issued a decision of Substantially Equivalent on January 19, 2021. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Biocore9, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2021
Date Received
May 6, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral, Resurfacing
Device Class
Class II
Regulation Number
888.3400
Review Panel
OR
Submission Type

Other clearances by Biocore9, LLC

  • K212761 — Biocore9 Acetabular Cup System (May 17, 2022)
  • K193122 — Biocore9 Humeral Resurfacing System (May 15, 2020)

Other clearances for product code KXA

  • K092198 — CORMET CEMENTLESS RESURFACING FEMORAL HEAD (April 15, 2010)
  • K082673 — CONSERVE PRESSFIT FEMORAL COMPONENT (December 12, 2008)
  • K071053 — RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD (June 29, 2007)
  • K070292 — DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS (April 26, 2007)
  • K062960 — CONSERVE FEMORAL RESURFACING COMPONENT (December 1, 2006)
  • K043542 — BIOPRO TARA FEMORAL RESURFACING COMPONENT (May 18, 2005)
  • K032659 — DEPUY ASR RESURFACING FEMORAL HEADS (December 4, 2003)
  • K023188 — PRESS-FIT HEAD RESURFACING DEVICE (December 11, 2002)
  • K021549 — CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM (August 1, 2002)
  • K021799 — CEMENTED FEMORAL HEAD RESURFING DEVICE (June 26, 2002)

FDA data resources