(85 days)
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
Biomet Manufacturing Corp. is modifying the manufacturing process of ultrahigh molecular weight polyethylene (UHMWPE) used in the fabrication of polyethylene acetabular components. The modified manufacturing process results in a higher cross-linked polyethylene. The highly cross-linked UHMWPE is infused with medical grade Vitamin E.
This document, K070364, is a 510(k) summary for Biomet Manufacturing Corp.'s "100 kGy E-Poly™ MaxRom™ Acetabular Liners." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this document.
Explanation:
- 510(k) Submissions: These submissions primarily focus on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (the predicate device). This often involves non-clinical testing (e.g., material properties, mechanical testing) and comparison of indications for use, technological characteristics, and safety/effectiveness profiles.
- Lack of Clinical Data: The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This means no human clinical trials were conducted or provided in this submission to evaluate the device's performance against clinical acceptance criteria.
- Focus on Manufacturing Modification: The core of this 510(k) is a modification to the manufacturing process of existing UHMWPE liners to create a higher cross-linked polyethylene infused with Vitamin E. The safety and effectiveness are supported by "substantial equivalence information, materials data, and testing results," which typically refers to non-clinical, benchtop, or in-vitro testing, not human clinical studies with patients.
In summary, as this is a 510(k) submission based on substantial equivalence and explicitly states no clinical testing was provided, the detailed information requested about acceptance criteria, clinical performance, and associated study methodology is not present.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.