(49 days)
No
The summary describes a mechanical implant (endoprosthesis) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is an endoprosthesis used for hip replacement due to medical conditions, which directly addresses a health problem.
No
Explanation: The provided text describes the OPTEON Unipolar Endoprosthesis as an implant used in hip replacement surgery. Its intended use is for actual replacement of the femoral head, not for diagnosing conditions.
No
The device description explicitly states it is a physical implant made of cast cobalt chrome, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The OPTEON Unipolar Endoprosthesis is a physical implant designed to replace the femoral head in hip surgery. It is used in vivo (within the body) during a surgical procedure.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The OPTEON Unipolar Endoprosthesis is for use with a modular femoral stem when hemiarthroplasty is indicated. The change to a total hip replacement can then be accomplished in the future without removing the femoral stem.
The OPTEON Unipolar is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis. osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for use in replacement of the femoral head following femoral neck fracture .
Product codes
87LZY
Device Description
The OPTEON Unipolar Endoprosthesis is a polished, truncated sphere made of cast cobalt chrome, ASTM F75. The high tolerance taper connection machined at the base of each unipolar component will mate with all Exactech femoral hip stems.
The external geometry approximates the shape of the normal femoral head and is intended for use in hemiatthroplasty. The modular system allows for future total hip arthroplasty without removal of the femoral stem.
The cast cobalt chrome geometry of the Exactech unipolar prosthesis has had many predecessors since the use of the Moore prosthesis over 50 years ago. The manufacturing advances in casting and materials technology has led to devices which exhibit increased structural strength and highly polished surfaces for decreased surface friction. The OPTEON Unipolar is pattemed after other clinically successful unipolar designs. Clinical results of the Unipolar device has been reported to be effective.
The OPTEON Unipolar is similar to the Corin Unipolar and the Howmedica Unipolar in material, finish, and spherical design. Both the Opteon and the Corin Unipolar have a taper machined into it that will mate directly to the femoral components. Both outside geometries are essentially truncated spheres. Both are manufactured from ASTM F-75 Cobalt Chrome.
The Exactech Opteon Unipolar device is similar to the Howmedica design in that both utilize metal spheres. The Exactech Unipolar is dissimilar from the Howmedica Unitrax® Unipolar System in the way the Unitrax component connects to the femoral stem. The inner portion of Howmedica's Unipolar contains a polyethylene insert which allows the intraoperative press fit assembly of a metal, tapered neck sleeve. Howmedica's Unipolar also offers various sizes of tapered neck sleeve choices.
A complete instrumentation and trial system is available to assist in accurate implantation of the Exactech OPTEON Unipolar Endoprosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
K960538 MAR 27 1996 001
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION FOR THE PREMARKET NOTIFICATION FOR THE OPTEON® Unipolar Endoprosthesis
Exactech®, Inc.
Establishment Registration Number 1038671
The Opteon® Unipolar Endoprosthesis is made of similar materials and is of a similar design to prostheses that were on the market before May 28, 1976. Additionally, the Opteon® Unipolar is of a 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:
Exactech, Inc. has supplied advertisements, brochures and/or catalog information from these companies to the FDA as evidence of equivalency. This literature is in the public domain. In addition, Exactech has provided the FDA design drawings, material specifications and photos of the Opteon Unipolar Endoprosthesis.
This device is appropriately placed in FDA classification:
Prosthesis, Hip, Hemi, Femoral, Metal Ball. Number 87LZY, Class II device, under 21 CFR 888.3560.
Device Description 1.
The OPTEON Unipolar Endoprosthesis is a polished, truncated sphere made of cast cobalt chrome, ASTM F75. The high tolerance taper connection machined at the base of each unipolar component will mate with all Exactech femoral hip stems.
The external geometry approximates the shape of the normal femoral head and is intended for use in hemiatthroplasty. The modular system allows for future total hip arthroplasty without removal of the femoral stem.
The cast cobalt chrome geometry of the Exactech unipolar prosthesis has had many predecessors since the use of the Moore prosthesis over 50 years ago. The manufacturing advances in casting and materials technology has led to devices which exhibit increased structural strength and highly polished surfaces for decreased surface friction. The OPTEON Unipolar is pattemed after other clinically successful unipolar designs. Clinical results of the Unipolar device has been reported to be effective.
1
The OPTEON Unipolar is similar to the Corin Unipolar and the Howmedica Unipolar in material, finish, and spherical design. Both the Opteon and the Corin Unipolar have a taper machined into it that will mate directly to the femoral components. Both outside geometries are essentially truncated spheres. Both are manufactured from ASTM F-75 Cobalt Chrome.
The Exactech Opteon Unipolar device is similar to the Howmedica design in that both utilize metal spheres. The Exactech Unipolar is dissimilar from the Howmedica Unitrax® Unipolar System in the way the Unitrax component connects to the femoral stem. The inner portion of Howmedica's Unipolar contains a polyethylene insert which allows the intraoperative press fit assembly of a metal, tapered neck sleeve. Howmedica's Unipolar also offers various sizes of tapered neck sleeve choices.
A complete instrumentation and trial system is available to assist in accurate implantation of the Exactech OPTEON Unipolar Endoprosthesis.
2. Material Specifications
The OPTEON Unipolar component is made from cast cobalt chrome which meets ASTM specification F75-87. The material chemical composition of cast cobalt chrome is based on ASTM F75-87.
- ന് Mechanical Testing
The cast cobalt chromium alloy exhibits mechanical properties in excess of 95,000 psi tensile strength, 65,000 psi yield strength, 8% elongation, and 8% reduction of area.
র্ব Range of Motion and Constraint
The Exactech OPTEON Unipolar Endoprosthesis is designed to mate with the appropriate femoral stem size dictated by the patient's anatomy. Likewise, the patient's range of motion and constraint is limited by the anatomy.
ട. Biocompatibility
According to ASTM F75-87, the material in this specification has been evaluated for biocompatibility. The results of these studies and the clinical history indicate a well-characterized level of local biological response.
2
Sterilization 6.
The OPTEON Unipolar Endoprostheses will be supplied sterile. They will be sterilized in their final, sealed packages by gamma irradiation at a contract sterilization facility. The sterilization protocol will be based on the Guidelines for Radiation Sterilization of Medical Devices, issued by the Association for Advancement of Medical Instrumentation Process Control.
Utilization of Implantation 7.
Selection of the OPTEON Unipolar component is made by the surgeon in relationship to the requirements of the patient. The surgeon should become thoroughly familiar with the technique of implantation of the prosthesis by: 1) appropriate reading of the literature and 2) training in the operative skills and techniques required for hip arthroplasty surgeries.
8. Indications
The OPTEON Unipolar Endoprosthesis is for use with a modular femoral stem when hemiarthroplasty is indicated. The change to a total hip replacement can then be accomplished in the future without removing the femoral stem.
The OPTEON Unipolar is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis. osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for use in replacement of the femoral head following femoral neck fracture .
க் Contraindications
Use of the OPTEON Unipolar is contraindicated in patients with active infection. patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis in patients with 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 of the system. The Unipolar is also contraindicated for use in patients with evidence of degenerative changes in the acetabulum and/or pelvic fractures.
HAPUBLIC\WPWINFILWARTHA\FDA\510kUNIPOLAR.S&E