(365 days)
Not Found
No
The summary describes a physical implant and its intended use, with no mention of software, algorithms, or data processing that would indicate AI/ML technology.
Yes
The device is described as an implant used as an adjunct to arthroplasty to treat degenerative or posttraumatic arthritis, aiming to preserve joint relationship, correct deformities, and alleviate pain and crepitation, indicating a direct therapeutic function.
No
The Metallic Spherical CMC Implant is described as an implant that acts as a spacer in cases of degenerative or post-traumatic arthritis of the carpometacarpal joint. Its intended use is to preserve joint relationship and allow capsuloligamentous reconstruction, not to diagnose a condition.
No
The device is a metallic implant, which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
- This device is a surgical implant intended to be placed inside the human body to treat a specific joint condition.
The description clearly states its purpose is to act as a spacer within the carpometacarpal joint and articulate directly on bone. This is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Metallic Spherical CMC Implant is intended to be used as an adjunct to resection arthroplasty of the carpometacarpal (CMC) joint in cases of degenerative arthritis or posttraumatic arthritis limited to that joint. It acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities. The implant will rest in a spherical cavity created by two hemispherical shapes in the trapezium and the first metacarpal. The implant will articulate directly on bone.
Use of the CMC Implant may be considered in cases of isolated carpometacarpal joint involvement from either degenerative or post-traumatic arthritis presenting:
- Localized pain and palpable crepitation during circumduction movement with axial compression of involved thumb ("grind test").
- Decreased motion, normal pinch and grip strength.
- X-ray evidence of arthritic changes and/or subluxation of the carpometacarpal joint.
- Associated unstable, stiff, or painful distal joints.
Product codes
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Device Description
The Metallic Spherical CMC Implant is made from cobalt chrome alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carpometacarpal (CMC) joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The Metallic Spherical CMC Implant demonstrates acceptable material strength.
Key Metrics
Not Found
Predicate Device(s)
K960534, Swanson Titanium Condylar Implant
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a stylized letter "W" in black. The "W" is formed by three triangles that are connected at their vertices. The triangles are arranged in a way that creates the shape of the letter "W". There is a small symbol that looks like an asterisk in parentheses below the letter.
FEB - 6 1997
Contact Person: Date:
Cliff Kline February 6, 1996
510(k) SUMMARY
| Trade/Proprietary Name: |
|---|
| Common Name: |
| Product Nomenclature: |
| Classification: |
| Predicate Device: |
Metallic Spherical CMC Implant Carpometacarpal (CMC) implant Prosthesis, wrist, carpal trapezium Class II Swanson Titanium Condylar Implant
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Description/Intended Use
The Metallic Spherical CMC Implant is intended to be used as an adjunct to resection arthroplasty of the carpometacarpal (CMC) joint in cases of degenerative arthritis or posttraumatic arthritis limited to that joint. It acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities. The implant will rest in a spherical cavity created by two hemispherical shapes in the trapezium and the first metacarpal. The implant will articulate directly on bone.
Use of the CMC Implant may be considered in cases of isolated carpometacarpal joint involvement from either degenerative or post-traumatic arthritis presenting:
- Localized pain and palpable crepitation during circumduction movement with ♪ axial compression of involved thumb ("grind test").
- ア Decreased motion, normal pinch and grip strength.
- X-ray evidence of arthritic changes and/or subluxation of the carpometacarpal レ joint.
- ♪ Associated unstable, stiff, or painful distal joints.
The Metallic Spherical CMC Implant is made from cobalt chrome alloy.
Substantial Equivalence
The Metallic Spherical CMC Implant is substantially equivalent to the Swanson Titanium Condylar Implant
Testing
The Metallic Spherical CMC Implant demonstrates acceptable material strength.