(54 days)
No
The document 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 described as an artificial replacement for the radial head to address pain, decreased motion, and joint destruction, which are therapeutic goals.
No
The device description and intended use indicate that this is a prosthesis for joint replacement, which is a therapeutic intervention, not a diagnostic tool.
No
The device description clearly states it is a "modular prosthesis designed for replacement of the proximal end of the radius" and is "made from ASTM F1537 cobalt chromium alloy," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. Examples include blood tests, urine tests, and genetic tests.
- This device is a surgical implant. It is a prosthesis designed to replace a part of the radial bone in the arm. It is surgically implanted into the patient's body.
The description clearly states its intended use is for replacement of the radial head due to various conditions and fractures, and the device description details its material and modular design for surgical implantation. This falls under the category of a medical device, specifically a prosthetic implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Ascension® Modular Radial Head is intended for:
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray
- resistance to conservative treatment
- Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection
- Revision following failed radial head arthroplasty
Product codes
87 KWI
Device Description
The Ascension® Modular Radial Head is an anatomically designed, single-use, modular prosthesis designed for replacement of the proximal end of the radius. It is made from ASTM F1537 cobalt chromium alloy. Head components available in six sizes and stem components available in four sizes are interchangeable and achieve assembly by means of a taper connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial head, radio-humeral and/or proximal radio-ulnar 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
Not Found
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.
0
OCT 2 2 2003 1
Page 31 of 157
510(k) SUMMARY
63,268
| SUBMITTER NAME: | Ascension Orthopedics, Inc.
8200 Cameron Road, C-140
Austin, TX 78754-3832 |
|-----------------|----------------------------------------------------------------------------------|
| 510(k) CONTACT: | Peter Strzepa
Phone: (512) 836-5001 |
| TRADE NAME: | Ascension® Modular Radial Head |
| COMMON NAME: | radial head prosthesis |
| CLASSIFICATION: | 21 CFR §888.3170 |
| PRODUCT CODE: | 87 KWI |
| PANEL: | Orthopedic and Rehabilitation Device |
PREDICATE DEVICE:
Avanta Orthopaedics, Inc., Radial Head Implant (K982288) Wright Medical Technology, Inc., Modular Radial Head (K991915)
DEVICE DESCRIPTION:
The Ascension® Modular Radial Head is an anatomically designed, single-use, modular prosthesis designed for replacement of the proximal end of the radius. It is made from ASTM F1537 cobalt chromium alloy. Head components available in six sizes and stem components available in four sizes are interchangeable and achieve assembly by means of a taper connection.
INTENDED USE:
The Ascension® Modular Radial Head is intended for:
- e Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- o joint destruction or subluxation visible on x-ray
- o resistance to conservative treatment
- Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection .
- . Revision following failed radial head arthroplasty
BASIS OF SUBSTANTIAL EQUIVALENCE:
A comparison of materials and design features, as well as performance tests and analyses, demonstrate that the Ascension® Modular Radial Head is substantially equivalent to the predicate devices.
page 1 of )
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2003
Mr. Peter Strzepa Vice President. Science and Technology Ascension Orthopedics, Inc. 8200 Cameron Road, C-140 Austin, TX 78754-3832
Re: K032686
Trade/Device Name: Ascension® Modular Radial Head Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: August 29, 2003 Received: August 29, 2003
Dear Mr. Strzepa:
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 (OS) 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. Peter Strzepa
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Millman
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:
K82686
032686
Device Name:
Ascension® Modular Radial Head
Indications for Use:
The Ascension® Modular Radial Head is intended for:
- Replacement of the radial head for degenerative or post-traumatic disabilities o presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray
- o resistance to conservative treatment
- Primary replacement after fracture of the radial head .
- . Symptomatic sequelae after radial head resection
- Revision following failed radial head arthroplasty �
(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
Mark N. Millman
10(k) Number K03268
Over-The-Counter Use _
(Optional Format 1-2-96)