(63 days)
The Exactech Total Hip System: 22mm Femoral Head is indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis and/or posttraumatic degenerative problems. It is also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present.
The Exactech 22mm Femoral Head is sized in three neck lengths: short (-3mm), standard (+2mm), long (+8mm). It is available in 22mm diameter. The femoral head is made of cobalt chromium alloy, a preferred metal alloy for bearing with The Ultra High Molecular Weight Polyethylene (UHMWPE), found in the acetabular components. The femoral head mates with the femoral stem by its precise internal taper lock. In addition, its overall design is similar to those used by Charnley and others since the early introduction of Total Hip Arthroplasty and assures adequate component thickness as put forth by Bartel for such components.
The provided text describes a 510(k) premarket notification for a medical device, the Exactech Total Hip System: 22mm Femoral Head. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical trials to establish de novo acceptance criteria and performance.
Therefore, the document does not contain the information requested regarding acceptance criteria and the results of a study designed to prove the device meets those criteria, as typically found in clinical trials for novel devices.
Here's why and what information is present:
- No Acceptance Criteria or Reported Device Performance: The document doesn't define specific performance metrics (e.g., failure rates, wear rates, clinical scores) that the device is "accepted" against, nor does it present data from a study directly measuring those metrics for the Exactech 22mm Femoral Head.
- Study Type: This is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a predicate device. It is not a clinical study designed to test novel acceptance criteria.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: All these categories are related to a clinical study or a study validating an AI/diagnostic device. Since this is a submission for substantial equivalence of an orthopedic implant, these concepts are not applicable or addressed in the provided text.
What the document does provide in lieu of a de novo study:
- Similarity to Predicate Devices: The core of the submission is to assert that the Exactech 22mm Femoral Head is "of similar design to prostheses that were on the market before May 28, 1976" and "of similar design to other components on the market that have been determined to be equivalent to devices on the market prior to May 28, 1976."
- Predicate Devices Listed: Orthomet, Zimmer-Charnley Type Total Hip, Exactech® Femoral Heads.
- Material Equivalence: The material (cobalt chromium alloy, ASTM F90-87) is stated to have a "long history of use in orthopaedic applications" and its biocompatibility is "well characterized by a history of clinical studies" and laboratory studies. References are cited (Charnley, Halley & Charnley, Mirra et al., Turner et al.). These references are likely studies on the material itself, not specifically on the Exactech 22mm Femoral Head.
- Design Considerations: The document describes the design (sizing, material, mating mechanism) as "similar to those used by Charnley and others since the early introduction of Total Hip Arthroplasty."
- Sterilization: Method and Sterility Assurance Level (SAL) are described, referencing AAMI Guidelines.
In summary, this document is a regulatory submission for device clearance based on equivalence, not a report of a study establishing and meeting new performance acceptance criteria for a novel device.
§ 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.