(159 days)
Not Found
Not Found
No
The device description and intended use are for a physical implant made of silicone elastomer, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as an implant used in the treatment of thumb disabilities due to various forms of arthritis, which indicates a therapeutic purpose.
No
The device description clearly states that the Avanta Orthopaedics Trapezium Implant is "intended to be implanted in metacarpal bone of the thumb with resection of the trapezium bone of the wrist" and "is intended to be used in the treatment of thumb disabilities," indicating it is a therapeutic implant, not a diagnostic tool.
No
The device description clearly states it is an "implant" made of "molded silicone elastomer," indicating it is a physical hardware device intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device description: The Avanta Orthopaedics Trapezium Implant is a physical implant designed to be surgically placed within the body to treat a specific condition (thumb arthritis). It does not perform any tests on samples.
Therefore, based on the provided information, this device falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Avanta Orthopaedics Trapezium Implant may be considered for use in thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows:
- Localized pain and palpable crepitation during circumduction movements with axial . compression of the thumb.
- Loss of the thumb motion with decrease of normal pinch and grip strength. .
- Radiological evidence of arthritic changes of the trapeziometacarpal joint, trapeziotrapezoid . and trapezium second metacarpal joint, singly or in combination.
- Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity. .
- Following an old Bennet fracture. .
Prescription Use
(Per 21 CFR 801.109)
Product codes (comma separated list FDA assigned to the subject device)
KYI
Device Description
The Avanta Orthopaedics Trapezium Implant is a device intended to be implanted in metacarpal bone of the thumb with resection of the trapezium bone of the wrist. It is made of molded silicone elastomer. The device is intended to be used in the treatment of thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows: Localized pain and palpable crepitation during circumduction movements with axial compression of the thumb. Loss of thumb motion with decrease of normal pinch and grip strength. Radiological evidence of arthritic changes of the trapeziometacarpal joint, trapeziotrapezoid and trapezium second metacarpal joint, singly or in combination.. Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity. Old Bennet fracture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metacarpal bone of the thumb, trapezium bone of the wrist, trapeziometacarpal joint, trapeziotrapezoid and trapezium second metacarpal 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
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
510(k) SUMMARY
JUN - 3 1997
die and the
Submitter's Name:
管家 中 - 亚
Contact: Date of Preparation: Device Name: Common Name: Predicate Device:
Avanta Orthopaedics 9369 Carroll Park Drive, Suite A San Diego, CA 92121 619-452-8580
Louise Focht November 1, 1996 Avanta Orthopaedics Trapezium Implant Trapezium Implant Dow Corning Corporation Silastic Swanson Trapezium Implant
Device Description:
The Avanta Orthopaedics Trapezium Implant is a device intended to be implanted in metacarpal bone of the thumb with resection of the trapezium bone of the wrist. It is made of molded silicone elastomer. The device is intended to be used in the treatment of thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows: Localized pain and palpable crepitation during circumduction movements with axial compression of the thumb. Loss of thumb motion with decrease of normal pinch and grip strength. Radiological evidence of arthritic changes of the trapeziometacarpal joint, trapeziotrapezoid and trapezium second metacarpal joint, singly or in combination.. Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity. Old Bennet fracture.
1
Comparison of Current Design to Predicate Devices:
| Item | Avanta Product | Dow Corning Corporation |
|---|---|---|
| Indications for use | osteoarthritis, post-traumatic | osteoarthritis, post-traumatic |
| arthritis or rheumatoid arthritis | arthritis or rheumatoid arthritis | |
| of the trapeziometacarpal joint | of the trapeziometacarpal joint | |
| localized pain and palpable | localized pain and palpable | |
| crepitation during circumduction | crepitation during circumduction | |
| with axial compression of the | with axial compression of the | |
| thumb | thumb | |
| loss of thumb motion, decrease | loss of thumb motion, decrease | |
| of normal pinch and grip | of normal pinch and grip | |
| strength | strength | |
| radiological evidence of arthritic | radiological evidence of arthritic | |
| changes of the | changes of the | |
| trapeziometacarpal, | trapeziometacarpal, | |
| trapezioscaphoid, | trapezioscaphoid, | |
| trapeziotrapezoid and trapezium | trapeziotrapezoid and trapezium | |
| second metacarpal joints, singly | second metacarpal joints, singly | |
| or in combination | or in combination | |
| unstable, stiff, or painful distal | unstable, stiff, or painful distal | |
| joint of the thumb or swan-neck | joint of the thumb or swan-neck | |
| deformity | deformity | |
| old Bennett fracture | old Bennett fracture | |
| Use | Single use | |
| Fixation | stem in intramedulary canal | |
| Constraint | non constrained | |
| Material | Silicone Elastomer | |
| Sizes | 3 sizes, 10, 20, 30 |
Similarities of the Avanta Orthopaedics Trapezium Implant and the Dow Corning Corporation Swanson Trapezium Implant include; - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Both devices are intended for single use only;
Both devices are intended for surgical implantation longer than 30 days;
Both devices are placed into the metacarpal bone of the thumb and replace the trapezium bone of the wrist;
Both devices are made of industry standard silicone elastomer. No new materials are introduced in either product;
Both devices are comparably sized in diameter;
Both devices have the same indications for use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and features the department's name around the perimeter. In the center is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 1997
Ms. Louise M. Focht Vice President, Research and Development Avanta Orthopaedics 9369 Carroll Park Drive, Suite A San Diego, California 92121
Re : K965204 Trade Name: Avanta Orthopaedics Trapezium Implant Regulatory Class: II Product Code: KYI Dated: March 20, 1997 Received: March 21, 1997
Dear Ms. Focht:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will
3
Page 2 - Ms. Louise M. Focht
verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any ^ obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
C. Celia M. Witten, Ph.D., M.
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Device Intended Use
Avanta Orthopaedics Trapezium Implant may be considered for use in thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows:
- Localized pain and palpable crepitation during circumduction movements with axial . compression of the thumb.
- Loss of the thumb motion with decrease of normal pinch and grip strength. .
- Radiological evidence of arthritic changes of the trapeziometacarpal joint, trapeziotrapezoid . and trapezium second metacarpal joint, singly or in combination.
- Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity. .
- Following an old Bennet fracture. .
Prescription Use
(Per 21 CFR 801.109)
P. CODD
Divis Division of General Restorative 510(k) Number