Search Results

1. Noninflammatory 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.

The Echo™ Bi-Metric® Press-Fit Stems are intended for uncemented use only.

The Echo™ Bi-Metric® Press-Fit Stems are hip stems made from Ti-6Al-4V conforming to ASTM F-136. Portions of the devices are coated with Porous Plasma Spray conforming to ASTM F-1580.

This document is a 510(k) summary for the Biomet Echo™ Bi-Metric® Press-Fit Stems, a hip stem device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria.

Therefore, the information requested regarding acceptance criteria and performance study details is not available in the provided text.

The document explicitly states:

• Non-Clinical Testing: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use." This suggests fundamental functional checks, but not a detailed performance study with explicit acceptance criteria against a specific target.
• Clinical Testing: "Clinical testing was not required for the predicate devices. Therefore, this submission contains no clinical testing." This confirms no clinical trial was conducted for this device to prove its performance.

The submission is based on demonstrating that the Echo™ Bi-Metric® Press-Fit Stems have "a similar design with similar technological features" and "the same intended use, indications for use, and utilize the same Biomet Type I Taper" as the predicate device (Altra Press-Fit Hip Stem K063002). This is a common pathway for medical device approval where a new device is shown to be substantially equivalent to an already legally marketed device, and extensive new performance studies (especially clinical ones) are not always required.

In summary, the provided document does not contain the information required to populate the table or answer the questions about acceptance criteria and a performance study.

Ask a specific question about this device