Search Results

Rx90™ Low Profile Acetabular Shells are intended for cemented or non-cemented total hip replacement 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 using other techniques.
5. Revision of previously failed total hip arthroplasty.

Specific indications for compatible components that can be used with the above acetabular shells include:

Salvage/Oncology Hip and Total Femur System (K002757, K021380, K033871)
9. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis
10. Correction of varus, valgus or post traumatic deformity
11. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
12. Ligament deficiencies
13. Tumor resections
14. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
15. Revision of previously failed total joint replacement
16. Trauma

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. (K990830, K042774)

The Freedom™ Constrained Liners are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high dislocation due to a history of prior dislocation, joint or bone loss, soft laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. (030047)

The Rx90™ Low Profile Acetabular System is a metal backed shell with a polyethylene inner liner intended for cemented or cementless replacement of the acetabular portion of a total hip replacement. The metallic shell is available in diameters of 40mm to 70mm and two different hole configurations. Liners are available with internal diameters of 22mm, 28mm, 32mm and 36mm. Liner styles include Hi-Wall, 10 Degree, MROM, +5mm Hi-Wall, +10 Degree, +5mm Flat Face and Constrained.

The provided 510(k) summary for the Biomet Rx90™ Low Profile Acetabular System indicates that no clinical testing was performed to demonstrate the device meets acceptance criteria. The submission relies solely on non-clinical mechanical testing and substantial equivalence to predicate devices.

Therefore, many of the requested details regarding clinical studies, sample sizes, ground truth establishment, and expert involvement are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Not applicable. No clinical test set was used. Non-clinical mechanical testing implicitly uses test specimens for evaluation, but the sample size and provenance of these materials are not detailed in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. No clinical test set was used requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This device is a medical implant (acetabular system), not an AI-assisted diagnostic or treatment device. No MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a hardware medical device; it does not involve algorithms or AI that would have standalone performance.

7. The Type of Ground Truth Used

• For the non-clinical mechanical testing, the "ground truth" would be established engineering standards or internal specifications for mechanical properties (e.g., strength, durability, wear resistance). The specific standards or methods used are not detailed in this summary, but the general statement is "Mechanical testing has demonstrated the ability of the device to perform as expected."

8. The Sample Size for the Training Set

• Not applicable. No clinical training set was used.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. No clinical training set was used.

Summary of Device Acceptance:

The Biomet Rx90™ Low Profile Acetabular System gained 510(k) clearance based on substantial equivalence to previously marketed predicate devices (K920639, K926107, K030055, K023357) and non-clinical mechanical testing. The summary explicitly states "Clinical Testing: None provided," indicating that the device's acceptance was not based on human clinical trials demonstrating performance against specific disease outcomes or patient data. Instead, the focus was on demonstrating that its technological characteristics (materials, design, function) are similar or identical to predicate devices and that it performs as expected under mechanical stress.

Ask a specific question about this device