(212 days)
Not Found
Not Found
No
The summary describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a prosthesis indicated for replacement of finger joints disabled by arthritis, which is a therapeutic purpose.
No
Explanation: The device is a prosthesis used for replacement of finger joints, which is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "flexible, one-piece, hinged silicone elastomer implant," which is a physical hardware component, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The DePuy DuPont Finger Joint Prosthesis is a physical implant designed to replace a joint in the finger. It is surgically implanted into the body.
- Intended Use: Its intended use is to replace damaged joints, not to analyze samples from the body.
The information provided clearly describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The DePuy DuPont Orthopaedics (DDO) Finger Joint Prosthesis is indicated for cementless replacement of the metacarpophalangeal (MCP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
Product codes (comma separated list FDA assigned to the subject device)
87 KYJ
Device Description
The DePuy DuPont Orthopaedics (DDO) Finger Joint Prosthesis is a flexible, one-piece, hinged silicone elastomer implant designed to be implanted across the metacarpophalangeal (MCP) joint. The proximal and distal stems of the prosthesis form a 30° angle which mimics the approximate position of the joint when the hand is relaxed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metacarpophalangeal (MCP) joints 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Flexural fatigue testing shows that the DDO Finger Joint implants sustain the same or less damage than the Swanson or Sutter implants when cycled through a total of 90° of flexion/extension for 10 million cycles.
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
§ 888.3230 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
5970544
SUMMARY OF SAFETY AND EFFECTIVENESS SEP 1 2 1997
| NAME OF FIRM: | DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|--------------------------------------|------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Cheryl Hastings
Manager, Clinical Affairs |
| TRADE NAME: | DePuy DuPont Orthopaedics
Finger Joint Prosthesis |
| COMMON NAME: | Finger Joint Prosthesis |
| CLASSIFICATION: | 888.3230 Finger joint, polymer, constrained
prosthesis |
| DEVICE PRODUCT CODE: | 87 KYJ |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | Sutter Avanta MCP Joint Prosthesis
Dow Corning Wright Swanson Finger Joint
Implant |
DEVICE DESCRIPTION AND INTENDED USE:
The DePuy DuPont Orthopaedics (DDO) Finger Joint Prosthesis is a flexible, one-piece, hinged silicone elastomer implant designed to be implanted across the metacarpophalangeal (MCP) joint. The proximal and distal stems of the prosthesis form a 30° angle which mimics the approximate position of the joint when the hand is relaxed.
The DDO Finger Joint Prosthesis is indicated for cementless replacement of the metacarpophalangeal (MCP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DDO Finger Joint Prosthesis is substantially equivalent to both the Dow Corning Wright Swanson Finger Joint Implant and the Sutter Avanta MCP Joint Prosthesis in that all of these implants are intended to replace the MCP joint when it is damaged due to rheumatoid, degenerative or traumatic arthritis. All of these implants are manufactured from silicone elastomer and all have a hinge design. The Swanson and Sutter implants are both designed as "straight" hinges while the DDO implant incorporates a 30° angle. Flexural fatigue testing shows that the DDO Finger Joint implants sustain the same or less damage than the Swanson or Sutter implants when cycled through a total of 90° of flexion/extension for 10 million cycles.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings and a head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 1997
Ms. Cheryl Hastings Manager, Clinical Affairs DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
K970544 Re: Trade Name: DePuy DuPont Orthopaedics Finger Joint Prosthesis Requlatory Class: II Product Code: KYJ Dated: June 13, 1997 Received: June 16, 1997
Dear Ms. Hastings:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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.
2
Page 2 - Ms. Cheryl Hastings
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 vitro 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,
Celia M. Witten, Ph.D.,
Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known) K970544
Device Name DePuy DuPont Finger Joint Prosthesis
Indications for Use:
The DePuy DuPont Finger Joint Prosthesis is indicated for cementless replacement of the metacarpophalangeal (MCP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
Concurrence of CDRH, Office of Device Evaluation
Signature
(Division Sign-Off) Division of General Restorative Dev 510(k) Number
Prescription Use
)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)