(87 days)
Not Found
No
The summary describes a physical implant made of silicone and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a prosthesis intended for cementless replacement of a joint disabled by arthritis, which falls under the definition of a therapeutic device designed to treat a medical condition.
No
The device description clearly states it is a "single-use, one-component hinged prosthesis designed to be implanted," indicating it is a therapeutic or replacement device, not one used for diagnosis.
No
The device description clearly states it is a physical, implantable prosthesis made of silicone elastomer, which is a hardware component.
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. These tests are performed outside of the body.
- Device Description: The Ascension® Silicone MCP is a prosthesis designed to be implanted into the body to replace a joint. This is an in vivo device, meaning it is used inside the body.
The intended use and device description clearly indicate that this is a surgical implant, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Ascension® Silicone MCP is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative, or traumatic arthritis.
Product codes
87 KYJ
Device Description
The Ascension Silicone MCP is an anatomically designed, single-use, one-component hinged prosthesis designed to be implanted without hone cement across the metacarpophalangeal joint. It is made from flexible, injection-molded, medical grade silicone elastomer. The proximal and distal stems of the Ascension Silicone MCP are pre-flexed at 30° to match the approximate natural 30° flexion stance of the relaxed human hand.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metacarpophalangeal (MCP) joint of the finger
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
Performance tests and analyses demonstrate that the Ascension® Silicone MCP is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3230 Finger joint polymer constrained prosthesis.
(a)
Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.(b)
Classification. Class II.
0
510(k) SUMMARY
| SUBMITTER NAME: | Ascension Orthopedics, Inc.
8200 Cameron Road, C-140
Austin, TX 78754-3832 | NOV 2 5 2002 |
|-----------------|----------------------------------------------------------------------------------|--------------|
| 510(k) CONTACT: | Robert M. Wolfarth
Phone: (512) 836-5001 | |
| TRADE NAME: | Ascension® Silicone MCP | |
| COMMON NAME: | finger joint implant | |
| CLASSIFICATION: | 21 CFR §888.3230, finger joint, polymer, constrained prosthesis
(Class II) | |
| PRODUCT CODE: | 87 KYJ | |
| PANEL: | Orthopedic Devices | |
PREDICATE DEVICE:
The DePuy Silicone MCP (K970544), which was determined by the FDA to be substantially equivalent to the Sutter Avanta MCP Joint Prosthesis and the Dow Corning Wright Swanson Finger Joint Implant on September 12, 1997.
DEVICE DESCRIPTION:
The Ascension Silicone MCP is an anatomically designed, single-use, one-component hinged prosthesis designed to be implanted without hone cement across the metacarpophalangeal joint. It is made from flexible, injection-molded, medical grade silicone elastomer. The proximal and distal stems of the Ascension Silicone MCP are pre-flexed at 30° to match the approximate natural 30° flexion stance of the relaxed human hand.
INTENDED USE:
The Ascension® Silicone MCP is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative, or traumatic arthritis.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Performance tests and analyses demonstrate that the Ascension® Silicone MCP is substantially equivalent to the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "HUMAN SERVICES • USA" are arranged in a circular pattern around the top of the symbol. The logo is black and white.
NOV 2 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Robert M. Wolfarth Senior Regulatory Affairs Specialist Ascension Orthopedics, Inc. 8200 Cameron Road, Suite C-140 Austin, Texas 78754-3832
Re: K022892
Trade/Device Name: Ascension® Silicone MCP Regulation Number: 21 CFR 888.3230 Regulation Name: Finger joint polymer constrained prosthesis Regulatory Class: Class II Product Code: KYJ Dated: August 29, 2002 Received: August 30, 2002
Dear Mr. Wolfarth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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, good 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Robert M. Wolfarth
This letter will allow you to begin marketing your device as described in your Section 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), 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
R-Mach-Miller
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(K) Number: K022892
Ascension® Silicone MCP Device Name:
Indications for Use:
·
The Ascension® Silicone MCP is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by theumatoid, degenerative, or traumatic arthritis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Division Sign-Off)
Division of General, F orative
and Neurological Dev. s
| 510(k) Number | K022892 | (Optional Format 1-2-96) |
|---|---|---|
| --------------- | --------- | -------------------------- |