(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.
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DEC 27 1996
510(K) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION IN THE PREMARKET NOTIFICATION FOR THE EXACTECH TOTAL HIP SYSTEM: 22mm FEMORAL HEAD
Exactech, Inc.
Establishment Registration Number 1038671
The Exactech 22mm Femoral Head is made of similar materials and is of a similar design to prostheses that were on the market before May 28, 1976. Additionally, the 22mm Femoral Head is 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. These predicates include, but are not limited to:
- Orthomet
- Zimmer-Charnley Type Total Hip
- Exactech® Femoral Heads .
In addition, Exactech provided to the FDA, design drawings, and material specifications characterizing the 22mm Femoral Head
The Food and Drug Administration, in rules listed in the Federal Register. Friday. September 4, 1987, as Hip Joint Metal/Polymer Semi-Constrained Prosthesis, Section 888.3350 and Docket No. 78N3075, as a class II Device.
Design Considerations
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.
Design Parameters
The Exactech Total Hip System: 22mm Femoral Head consists of various neck lengths and is made from forged high strength cobalt chromium. The components are available in a range of sizes to fit varying anatomical requirements. The device is designed for use with all Exactech femoral components. A complete trial set and instrumentation is available to assist in accurate implantation of the prosthetic components. Design drawings are typical for such components that have been used in the industry since their introduction by Charnley in the late '60's.
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Material Specifications
The Exactech 22mm Femoral Head is manufactured from wrought high strength cobalt chromium corresponding with ASTM F90-87.
Biocompatibility
Cobalt Chromium has a long history of use in orthopaedic applications. Its biological response has been well characterized by a history of clinical studies (Chamley, J., Cupiz, A., "The Nine and Ten Year Results of the Low Friction Arthroplasty of the Hip", Clinical Orthopaedics, Vol 95, No. 9, 1973 .; Halley, D., Charnley, J. "Results of Low Friction Arthroplasty in Patients 30 Years of Age and Younger", Clinical Orthopaedics, No. 112, October, 1975 and Mirra, J., Amstutz, H., Matos, M., and Gold, R., "The Pathology of Joint Tissues and Its Clinical Relevance in Prosthesis Failure". Clinical Orthopaedics, No. 117, June, 1976) and by laboratory studies (Turner, J., Lawrence, W., and Autian, J., "Subacute Toxicity Testing of Biomaterials Using Histopathologic Evaluation of Rabbit Muscle Tissue," Journal of Biomedical Materials Research, Vol 7, 1973. Compatibility of Biocompatibility of Materials for Total Joint Replacement". Journal of Biomed. Mater. Research, Vol 10, No.2, 1976.). These tests include data on human and animal performance and show that the tissue exhibits excellent biocompatibility.
See Volume II for References
Sterilization
The Exactech 22mm Femoral Head will be sterilized by gamma irradiation. The Sterility Assurance Level (SAL) is 10th Exactech utilizes Method 3, Protocol B from the "AAMI Guideline for gamma radiation sterilization" for the sterility dose setting and validation procedure.
Utilization and Implantation
Selection of the Exactech Total Hip System: 22mm Femoral Head depends on the judgement of the surgeon in relationship to the requirements of the patient. The surgeon should become thoroughly familiar with the technique of implantation by appropriate reading of the literature, and training in the operative skills and techniques required for total hip arthroplasty surgery.
Indications
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.
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Contraindications
Use of the Exactech 22mm Femoral Head is contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure to the system.
:
§ 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.