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510(k) Data Aggregation
K Number
K201219Device Name
Biocore9 Femoral Head Resurfacing Component
Manufacturer
BioCore9 LLC
Date Cleared
2021-01-19
(258 days)
Product Code
KXA
Regulation Number
888.3400Why did this record match?
Applicant Name (Manufacturer) :
BioCore9 LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biocore9 Femoral Resurfacing Head Component, is indicated for the treatment of painful hip arthritis due to post-traumatic arthritis, or rheumatoid arthritis, as well as painful hip arthroplasty when sufficient femoral head and neck stock exist to stabilize a resurfacing femoral head. The Biocore9 Femoral Resurfacing Head Component is intended for cemented use only. This device is intended for hemi-arthroplasty only.
Device Description
The Biocore9 Femoral Resurfacing Head component is a non-constrained orthopedic implant intended to replace the articular surface of the existing femoral head in the patient's hip joint. The Biocore9 Femoral Resurfacing Head Component is intended for in the reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis. Sufficient bone stock on the femoral head and neck is necessary to stabilize a resurfacing femoral component. This device is intended for cemented use only. Components are available in thirteen sizes with available outside diameters 39.5, 41, 42.5, 47, 49, 51, and 52.5 mm.
The Biocore9 Femoral Resurfacing Head Component is manufactured from Ti-6Al-4V alloy (ASTM F136-13) with a Titanium Nitride (TiN) thin film ceramic coating. The titanium nitride coating is an inert, highly adherent, near diamond-hard surface coating.
The Femoral Resurfacing component is axisymmetric with a truncated spherical shell and a tapered central alignment stem. The component consists of a thin-walled spherical shell. The internal surface of the spherical shell is covered with a porous coating consisting of titanium beads. The stem is not porous coated.
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