(64 days)
- Noninflammatory 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.
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.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.