(356 days)
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No
The 510(k) summary describes a physical implant made of ceramic and its intended use as a spacer in joint surgery. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The performance studies focus on material strength, not algorithmic performance.
Yes
The device is intended to be used as an adjunct to resection arthroplasty of the carpometacarpal (CMC) joint in cases of degenerative arthritis or posttraumatic arthritis, acting as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities. These actions are rehabilitative or palliative, which are characteristics of a therapeutic device.
No
The device is an implant designed to replace part of a joint in cases of arthritis, not to identify or diagnose a condition. Its function is therapeutic/reconstructive rather than diagnostic.
No
The device is a physical implant made of ceramic material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Ceramic Spherical CMC Implant is a physical implant designed to be surgically placed within the body to act as a spacer in a joint. It does not analyze or test biological samples.
- Intended Use: The intended use clearly describes a surgical procedure and the implant's role in supporting the joint structure.
Therefore, based on the provided information, this device falls under the category of a surgical implant rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ceramic 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 ioint.
- Associated unstable, stiff, or painful distal joints.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Ceramic Spherical CMC Implant is made from alumina or zirconia ceramic.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
carpometacarpal (CMC) joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Ceramic Spherical CMC Implant demonstrates acceptable material strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Swanson Titanium Condylar Implant
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 and white. The "W" is formed by two thick, diagonal lines that converge at the bottom, creating a V-shape. The lines are separated by a white space, giving the impression of two distinct shapes forming the letter. The image has a simple, graphic design.
Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo includes the company name in a bold, sans-serif font, with the words "MEDICAL TECHNOLOGY, INC." appearing in a smaller font size below. The address "5677 Airline Road, Arlington, TN 38002" is printed below the company name, followed by the phone number "901-867-9971".
Contact Person: l)ate:
Cliff Kline February 14, 1996
510(k) SUMMARY
FEB - 6 1997
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| Common Name: |
| Product Nomenclature: |
| Classification: |
| Predicate Device: |
C'eramic 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 Ceramic 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").
- ﺮ Decreased motion, normal pinch and grip strength.
- ♪ X-ray evidence of arthritic changes and/or subluxation of the carpometacarpal ioint.
- ♪ Associated unstable, stiff, or painful distal joints.
The Ceramic Spherical CMC Implant is made from alumina or zirconia ceramic.
Testing
The Ceramic Spherical ( MC Implant demonstrates acceptable material strength.