RADIAL HEAD IMPLANT by AVANTA ORTHOPAEDICS, INC.

Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral 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 .

Device Description

The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

AI/ML Overview

This appears to be a 510(k) premarket notification for a medical device (radial head implant), not a study analyzing the performance of a device or an AI algorithm. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details are not present in the provided text.

The document is a regulatory submission demonstrating substantial equivalence to a predicate device, focusing on design characteristics and intended use, rather than a clinical or performance study report.

If you have a document that describes a study on a device's performance, I can analyze it for the requested information.

Summary

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SEP 8 1000

Image /page/0/Picture/2 description: The image shows the word "AVANTA" in large, bold, serif font. Below the word "AVANTA" is the word "ORTHOPAEDICS" in a smaller, sans-serif font. The letters are black against a white background. The image appears to be a logo or heading for a company or organization related to orthopaedics.

510 (k) Summary

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

June 29, 1998 Prepared:

Avanta Orthopaedics, Inc. Applicant: 9369 Carroll Park Drive, Suite A San Diego, CA 92121

619-452-8580 Telephone: 619-452-9945 Fax: Contact: Louise M. Focht

Device Name: Device Trade Name: Device Classification: Reviewing Panel: Regulation Number Product Code: Predicate Device:

Registration Number: Owner Operator Number:

Elbow joint radial (hemi-elbow) prosthesis Radial head implant Class II Orthopedic 888.3170 87 KWI Swanson Titanium Radial Head Implant Medical manufactured by Wright Technologies (K944507). 2030506 9001389

Device Description:

The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

Indications for Use:

A vanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:

Replacement of the radial head for degenerative, or post-traumatic disabilities . presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray .
- resistance to conservative treatment .

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Primary replacement after fracture of the radial head .
Symptomatic sequelae after radial head resection .

Comparison to Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the Dow Corning Corporation Silastic Swanson Radial Head Implant.

Regulatory Class: II 87 KYI Product Code:

Item	Avanta Product	Wright Medical Technology
Use	Single use	Single use
Fixation	stem in intramedullary canal	stem in intramedullary canal
Constraint	non constrained	non constrained
Material	Co-Cr	Titanium
Sizes	3 sizes	5 sizes
Indications for use	Avanta Orthopaedics RadialHead implant is intended forreplacement of the proximal endof the radius:Replacement of the radial headfor degenerative, or post-traumatic disabilities presentingpain, crepitation and decreasedmotion at the radio humeral andor proximal radio-ulnar jointwith :joint destruction orsubluxation visible on x-ray resistance to conservativetreatment Primary replacement afterfracture of the radial headSymptomatic sequelae afterradial head resection	Swanson Titanium Radial Headimplant is intended forreplacement of the proximal endof the radius:Replacement of the radial headfor degenerative, or post-traumatic disabilities presentingpain, crepitation and decreasedmotion at the radio humeral andor proximal radio-ulnar jointwith :joint destruction orsubluxation visible on x-ray resistance to conservativetreatment Primary replacement afterfracture of the radial headSymptomatic sequelae afterradial head resection

Similarities of the Avanta Orthopaedics Radial Head Implant and the Wright Medical Technology, Inc. Radial Head Implant include;

Both devices are intended for single use only;

Both devices are intended for surgical implantation longer than 30 days;

Both devices are placed into the intramedullary canal of the proximal end of the radius;

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Both devices are made of industry standard materials. No new materials are introduced in either product;

Both devices are comparably sized in diameter;

Both devices have the same indications for use.

Summary:

The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 8 1998

Ms. Louise M. Focht Avanta Orthopaedics, Inc. 9369 Carroll Park Drive Suite A San Diego, California 92121

Re : K982288 Trade Name: Radial Head Implant Requlatory Class: II Product Codes: KWI Dated: June 29, 1998 Received: June 30,1998

Dear Ms. Focht:

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 Requlations, Title 21, Parts 800 to 895. ਕੇ 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 In addition, FDA may publish further announcements action. 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.

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Page 2 - Ms. Louise M. Focht

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., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

510 (k) Number (If Known): 9 822288 Device Name: Radial Head

Indications for Use:

Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:

Replacement of the radial head for degenerative, or post-traumatic disabilities . presenting pain, crepitation and decreased motion at the radiohumeral 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 .

Prescription Use
(Per 21 CFR 801.109)

bcoilly

(Division Sign-Off) Division of General Restorative Device 510(k) Number.

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.