(158 days)
Not Found
No
The summary describes a physical implant (silicone spacer) with no mention of software, algorithms, or data processing, which are typically associated with AI/ML in medical devices.
Yes.
The device is a joint replacement for patients with advanced osteoarthritis, post-traumatic arthritis, and rheumatoid arthritis, which are conditions treated by therapeutic devices.
No
The device description indicates it is a "single component silicone spacer" for "cementless replacement of the proximal interphalangeal joint," which is a prosthetic and not involved in diagnosis.
No
The device description clearly states it is a "single component silicone spacer" with physical stems and a hinge, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states the device is a "cementless replacement of the proximal interphalangeal joint," which is a surgical implant placed within the body.
- The intended use is for treating joint conditions. IVDs are used for diagnosis, monitoring, or screening, not for surgical intervention.
- There is no mention of analyzing biological samples. The device description focuses on the physical characteristics and function of the implant.
The device described is a surgical implant used for joint replacement.
N/A
Intended Use / Indications for Use
The indications for use of the Ascensions Silicone PIP are for replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, posttraumatic arthritis and rheumatoid arthritis.
The indications for use of the Ascension Silicone PIP are for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
Product codes
KYJ
Device Description
The Ascension® Silicone PIP is a single component silicone spacer consisting of a proximal and distal intramedullary stem and a central flexible hinge. The central flexible hinge has a pre-flexed angle of 15 degrees. The Ascension Silicone PIP is available in 6 sizes for use in left or right applications. Device components are provided sterile in individual packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal interphalangeal 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)
Reference Device(s)
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
K08223i.
| 6 | 510(k) Summary | JAN 12 2009 |
|---|---|---|
| SUBMITTER NAME: | Ascension Orthopedics, Inc. | |
| 8700 Cameron Road, #100 | ||
| Austin, TX 78754-3832 | ||
| 510(k) CONTACT: | Debbie Stearns | |
| Phone: (512) 836-5001 x1548 | ||
| TRADE NAME: | Ascension® Silicone PIP | |
| COMMON NAME: | Prosthesis, finger, constrained, polymer | |
| CLASSIFICATION: | 21 CFR 888.3230 | |
| PRODUCT CODE: | KYJ | |
| PANEL: | Orthopedic |
PREDICATE DEVICES:
K022892 - Ascension Silicone MCP K001922 - DePuy Neuflex PIP Finger
DEVICE DESCRIPTION:
The Ascension® Silicone PIP is a single component silicone spacer consisting of a proximal and distal intramedullary stem and a central flexible hinge. The central flexible hinge has a pre-flexed angle of 15 degrees. The Ascension Silicone PIP is available in 6 sizes for use in left or right applications. Device components are provided sterile in individual packaging.
INTENDED USE:
The indications for use of the Ascensions Silicone PIP are for replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, posttraumatic arthritis and rheumatoid arthritis.
BASIS OF SUBSTANTIAL EQUIVALENCE:
A comparison of the Ascension Silicone PIP and the DePuy NeuFlex PIP Finger Implant (K001922) and Ascension Silicone MCP (K022892) show similar material, design features, surgical technique and indications.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the upper half of the circle. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ascension Orthopedics, Inc. % Ms. Debbie Stearns 8700 Cameron Road, Suite 100 Austin, Texas 78754-3832
JAN 12 2009
Re: K082231
Trade/Device Name: Ascension Silicone PIP Regulation Number: 21 CFR 888.3230 Regulation Name: Finger joint polymer constrained prosthesis Regulatory Class: II Product Code: KYJ Dated: December 23, 2008 Received: December 29, 2008
Dear Ms. Stearns:
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.
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
2
Page 2 - Ms. Debbie Stearns
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Mulkerson
Mark N. Melkerson - Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(K) Number. K082231
Device Name:
5
Ascension® Silicone PIP
Indications for Use:
The indications for use of the Ascension Silicone PIP are for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801Subpart B) C |
OR
| Over-The-Counter Use | |
|---|---|
| (Part 21 CFR 801Subpart |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
L 082231