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Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision procedures where other treatment or devices have failed.

Specific indications for compatible components that can be used with the above modular heads include:
Salvage/Oncology Hip and Total Femur System components also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis.
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis.

The 100 kGy E-Poly™ Acetabular Liners are intended for cemented and uncemented applications with the following indications for use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision of previously failed total hip arthroplasty.

Biolox® delta Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Biomet Type I taper.

The 100 kGy E-Poly™ acetabular liners for the Biolox® delta Ceramic Heads are a larger size of the previously cleared 100 kGy E-Poly™ liners, K070364 and K070399.

This document is a 510(k) summary for a medical device (Biolox® delta Ceramic Heads with 100kGy E-Poly™ Acetabular Liners) and does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical studies of AI/software devices.

Instead, this document describes:

• Device Description and Indications for Use: The purpose and intended applications of the hip replacement components.
• Substantial Equivalence Claim: The device's technological similarity to previously cleared predicate devices (K042091, K051411, K061312 for ceramic heads; K070364, K070399 for acetabular liners).
• Non-Clinical Testing Confirmation: It states that all parameters of the "Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems" were met. This is a crucial point regarding "acceptance criteria" in this context; however, the specific acceptance criteria (e.g., mechanical strength thresholds, wear rates, biocompatibility standards) and the detailed results of the non-clinical tests are not provided in this summary.

Therefore, I cannot provide a response filling in the requested table and study details (sample size, experts, adjudication, MRMC, standalone performance, ground truth, training set) because the provided text does not contain this information.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and established non-clinical testing guidelines, rather than presenting a clinical study with new performance metrics against specific acceptance criteria for a novel AI/software device.

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