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

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Ascension® Modular Radial Head, a radial head prosthesis. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the following information is not applicable or extractable from the provided document:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
If a standalone (algorithm only without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc).
The sample size for the training set.
How the ground truth for the training set was established.

Explanation:

The 510(k) pathway, as indicated by the document (K032686), is for demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparisons of:

Intended Use: The Ascension® Modular Radial Head has an intended use as described in the document, which is compared to the predicate devices.
Technological Characteristics: The device description details its materials (ASTM F1537 cobalt chromium alloy), design (anatomically designed, single-use, modular prosthesis, six head sizes, four stem sizes, taper connection), which are compared to the predicate devices (Avanta Orthopaedics, Inc., Radial Head Implant (K982288) and Wright Medical Technology, Inc., Modular Radial Head (K991915)).
Performance Data: The document explicitly states "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." However, it does not provide the details of these performance tests (e.g., acceptance criteria, test results, methodology, sample sizes, or ground truth establishment). The specific details of these "performance tests and analyses" are typically found in other sections of the 510(k) submission, such as the biocompatibility, mechanical testing, or sterility data, but are not present in this summary.

This kind of submission typically focuses on engineering and material performance tests (e.g., fatigue strength, wear, construct stability) relevant to an orthopedic implant, rather than clinical study-based performance metrics with expert ground truth or AI algorithms.

Summary

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OCT 2 2 2003 1

Page 31 of 157

510(k) SUMMARY

63,268

SUBMITTER NAME:	Ascension Orthopedics, Inc.8200 Cameron Road, C-140Austin, TX 78754-3832
510(k) CONTACT:	Peter StrzepaPhone: (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:

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 )

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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.

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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,

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

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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)

Regulation Number and Section

§ 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.