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1. Painful hip arthritis refractory to medical management resulting from post-traumatic arthritis, osteoarthritis, or rheumatoid arthritis. 2. Painful femoral head. cup arthroplasty, or bi-polar or universal type femoral head replacement. 3. Cases where more conventional arthroplasty techniques or arthrodesis are contraindicated because of a difficult clinical management problem, age, sex, occupation, or height of the patient The Biocore9 Acetabular Cup System components are intended for use in total hip arthroplasty in primary or revision surgery of skeletally mature patients. The Biocore9 Acetabular Cup System shells and liners are single use implants intended for cemented or cementless arthroplasty.

The subject Biocore9 Acetabular Cup System includes acetabular shells, liners, and acetabular bone screws. Components are intended to replace the articular surface of the acetabular socket in the patient's hip joint. It is intended for the reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis or rheumatoid arthritis for patients who would be candidates for total hip procedure, whose acetabular socket has not been excessively damaged by disease or trauma and where damage is primarily associated with the articular surface damage. Acetabular components are available in nine sizes with available outside diameters from 50 mm to 66 mm in 2 mm increments. Bearing components are available in fourteen sizes from 39 mm to 52 mm ID in 1 mm increments. Screw components are available in 6.5 mm diameter in five sizes from 15 mm to 50 mm lengths. Biocore9 Cancellous Bone screws are manufactured from Ti6A14V alloy (ASTM F136) with low profile screw heads designed to fit the Acetabular shells with nominal diameter of 6.5 mm. The acetabular shell components are manufactured from Ti-6A1-4V alloy (ASTM F136) with a single radius spherical outer geometry coated with three layers of Commercially Pure (CP)-Ti (ASTM F67) spherical bead porous coating allowing for cemented or cementless fixation and an anatomical shaped rim to limit impingement with the femoral side of the joint or the psoas muscle. A crescent peripheral groove provides for assembly interlock and three rim tabs provide anti rotational interlock with the bearing liner. The acetabular shells are available in two configurations: one with no screw holes and a second with five screw holes for supplemental bone screw fixation. All surfaces are coated with Titanium Nitride (TiN) thin film ceramic coating. Porous structured acetabular shells are intended for cemented fixation. The acetabular cup bearing liner components are manufactured from UHMWPe (ASTM F648), GUR 1020 Highly cross linked UHMWPe (75KGy MRad /post irradiation annealed) which locks into the acetabular cup shell with ten flexible lip tabs and has three rotation resisting tabs. The liners have inner diameters (ID) intended for use with modular, unipolar, self-centering (bipolar), metallic or ceramic femoral heads within the 39-52 mm OD range and articulate with a femoral head of an appropriate corresponding diameter. The components of the subject device are compatible with the BioPro PSL Hip System femoral head and stems. The 510k numbers for the compatible BioPro devices are listed below: - BioPro PC Femoral Hip Component (K882146), O - O BioPro Hemi-Endo Modular Head (K895886), - BioPro Ziralloy Modular Femoral Head (K912641 & K925682), O - BioPro PSL Total Hip Replacement System (K922500), O - BioPro Hemi-Endo Modular Ceramic Head (K954768), O - BioPro BiPolar Head (K100761) O

The Biocore9 Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Porous-coated components are intended for cemented use only. This device is indicated for hemi-arthroplasty only. The Biocore9 Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder ioints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Porous-coated components are intended for cemented use only. This device is indicated for hemi-arthroplasty only.

The Biocore9 Humeral Head Resurfacing component is a non-constrained orthopedic implant intended to replace the articular surface of the existing humeral head in the patient's shoulder joint. It is intended for the reconstruction of painful and or severely disabled shoulder joints resulting from osteoarthritis or rheumatoid arthritis for patients who would be candidates for total shoulder procedure, whose proximal humerus has not been excessively damaged by disease or trauma and where damage is primarily associated with the articular surface of the humeral head. It is primarily intended to articulate with intact, natural, glenoid. Components are available in five sizes with available outside diameters from 40 mm to 56 mm in 4 mm increments. The Biocore9 Humeral Resurfacing Head Component is manufactured from Ti-6Al-4V alloy (ASTM F136-13) with a Titanium Nitride (TiN) thin film ceramic coating. The Humeral Resurfacing component is axisymmetric with a truncated shell and a tapered central stem. The component consists of a thin walled spherical shell. The Humeral resurfacing Component's rim is anatomical with a rounded relief. The exterior of the spherical surface is intended to articulate with the Glenoid. The internal surface of the spherical shell is covered with a porous coating consisting of titanium beads. The stem is not porous coated.