(78 days)
No
The device description and intended use clearly define a physical implant for joint replacement, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
A therapeutic device is one that treats or heals a condition. This device is a prosthesis, which replaces a damaged part of the body, rather than actively treating a disease.
No
The device is a prosthesis intended to replace part of a joint, which describes a treatment, not a diagnostic function.
No
The device description clearly indicates it is a physical implantable prosthesis made of pyrocarbon and graphite, intended for surgical replacement of a bone. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is intended to replace a part of the first metacarpal bone in cases of various joint conditions. This is a surgical implant used to treat a physical condition.
- Device Description: The description details a physical prosthesis made of pyrocarbon and graphite, designed for surgical implantation.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information for diagnosis. IVDs are used in vitro (outside the body) to diagnose or monitor conditions.
This device is a surgical implant or prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ascension® CMC is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.
Product codes
KYI
Device Description
The Ascension® CMC is intended for use as a hemi joint replacement for the base of the first metacarpal of the carpometacarpal (CMC) joint. The Ascension CMC is a one component prosthesis having a saddle configuration articular surface which bears against the mating saddle articular surface of the trapczium. The saddle design allows for flexion-extension joint motion and abduction-adduction motion. It is designed to be a press fit device. Each device is comprised of a pyrocarbon layer encasing a machined graphite substrate. The graphite substrate material is impregnated with a small amount (I atomic percent) of tungsten. This small amount of tungsten renders the graphite substrate radiopaque. The device is provided sterile in packaging containing a single device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metacarpal of the carpometacarpal (CMC) 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)
Performance tests conducted on Ascension CMC devices, in vitro material biocompatibility tests, and pre-clinical animal tests demonstrate that the Ascension CMC is substantially equivalent to the predicate device.
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
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) Premarket Notification Device: Ascension® CMC
061451
510(k) SUMMARY
AUG 1 1 2006 SUBMITTER NAME: Ascension Orthopedics, Inc. 8700 Cameron Road. C-100 Austin, TX 78754-3832 510(k) CONTACT: Glen Neally Ph: (512) 836-5001 TRADE NAME: Ascension® CMC COMMON NAME: prosthesis, wrist, carpal trapezium CLASSIFICATION: 21 CFR §888.3770 Wrist joint carpal trapezium polymer prosthesis PRODUCT CODE: KYI PANEL: Orthopedic Devices PREDICATE DEVICE: Ascension® PHS, (K041451)
DEVICE DESCRIPTION:
The Ascension® CMC is intended for use as a hemi joint replacement for the base of the first metacarpal of the carpometacarpal (CMC) joint. The Ascension CMC is a one component prosthesis having a saddle configuration articular surface which bears against the mating saddle articular surface of the trapczium. The saddle design allows for flexion-extension joint motion and abduction-adduction motion. It is designed to be a press fit device. Each device is comprised of a pyrocarbon layer encasing a machined graphite substrate. The graphite substrate material is impregnated with a small amount (I atomic percent) of tungsten. This small amount of tungsten renders the graphite substrate radiopaque. The device is provided sterile in packaging containing a single device.
INTENDED USE:
The Ascension® CMC is intended to replace the proximal end of the first metacarpal in cases of theumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture defonomianon or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Performance tests conducted on Ascension CMC devices, in vitro material biocompatibility tests, and pre-clinical animal tests demonstrate that the Ascension CMC is substantially equivalent to the predicate device.
1
Image /page/1/Picture/1 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 a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA", which is arranged in a circular pattern around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2006
Ascension Orthopedics, Inc. % Mr. Glen Neally VP of QA/RA/CA 8700 Cameron Road, Suite 100 Austin, Texas 78754
Re: K061451
Trade/Device Name: Ascension® CMC Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: Class II Product Code: KYI Dated: May 22, 2006 Received: May 25, 2006
Dear Mr. Neally:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became ine device is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encreate) ve togging to the Medical Device Amendments, or to conninesee prof to may 20, 1978, in excordance with the provisions of the Federal Food, Drug, devices that have been receised in avere approval of a premarket approval application (PMA). and Cosmette Act (1101) that as nevice, subject to the general controls provisions of the Act. The Tourmaly, therefore, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 rr your device to such additional controls. Existing major regulations affecting your device can may oc subject to back additions, 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 I Toast of advised that I Drivedantly that your device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must of any I oderal buttores and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Far 6075, abounding (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 production of to begin marketing your device as described in your Section 510(k)
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Page 2 - Mr. Glen Neally
premarket notification. The FDA finding of substantial equivalence of your device to a legally premaince nevice 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehrig
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
06145
510(K) Number:
Ascension® CMC Device Name:
The Ascension® CMC is intended to replace the proximal end of the first Indications for Use: metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aulian Dvelum for mym
- Restorative, and Neurological Devices
510(k) Number K061451