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510(k) Data Aggregation
(259 days)
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Painful hip arthritis refractory to medical management resulting from post-traumatic arthritis, osteoarthritis, or rheumatoid arthritis.
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Painful femoral head. cup arthroplasty, or bi-polar or universal type femoral head replacement.
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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:
This document is a 510(k) premarket notification for a medical device called the "Biocore9 Acetabular Cup System." As such, it does not contain the type of detailed study data and acceptance criteria information (such as AI model performance, expert ground truth establishment, or mMRMC studies) that would be found in a submission for an AI-powered device or diagnostic tool.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing of the physical components (e.g., material strength, wear simulation, screw testing). It does not describe an AI/ML component or a study to prove AI model performance.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device, as those details are not present in the provided text.
The information provided is relevant to the safety and effectiveness of the physical hip implant components, not to the performance of an algorithm or AI model.
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