AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT by AVANTA ORTHOPAEDICS, INC.

Avanta Orthopaedics Trapezium Implant may be considered for use in thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows: Localized pain and palpable crepitation during circumduction movements with axial compression of the thumb. Loss of the thumb motion with decrease of normal pinch and grip strength. Radiological evidence of arthritic changes of the trapeziometacarpal joint, trapeziotrapezoid and trapezium second metacarpal joint, singly or in combination. Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity. Following an old Bennet fracture.

Device Description

AI/ML Overview

The provided text is a 510(k) summary for the Avanta Orthopaedics Trapezium Implant. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in such studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other details about a study proving the device meets acceptance criteria. The document is a regulatory submission for substantial equivalence, not a clinical study report.

The FDA's finding of "substantial equivalence" in this context means the device is considered as safe and effective as a legally marketed predicate device, based on comparison, not necessarily based on a new performance study proving specific acceptance criteria.

Summary

{0}------------------------------------------------

K965204

510(k) SUMMARY

JUN - 3 1997

die and the

Submitter's Name:

管家中 - 亚

Contact: Date of Preparation: Device Name: Common Name: Predicate Device:

Avanta Orthopaedics 9369 Carroll Park Drive, Suite A San Diego, CA 92121 619-452-8580

Louise Focht November 1, 1996 Avanta Orthopaedics Trapezium Implant Trapezium Implant Dow Corning Corporation Silastic Swanson Trapezium Implant

Device Description:

The Avanta Orthopaedics Trapezium Implant is a device intended to be implanted in metacarpal bone of the thumb with resection of the trapezium bone of the wrist. It is made of molded silicone elastomer. The device is intended to be used in the treatment of thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows: Localized pain and palpable crepitation during circumduction movements with axial compression of the thumb. Loss of thumb motion with decrease of normal pinch and grip strength. Radiological evidence of arthritic changes of the trapeziometacarpal joint, trapeziotrapezoid and trapezium second metacarpal joint, singly or in combination.. Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity. Old Bennet fracture.

{1}------------------------------------------------

Comparison of Current Design to Predicate Devices:

Item	Avanta Product	Dow Corning Corporation
Indications for use	osteoarthritis, post-traumatic	osteoarthritis, post-traumatic
	arthritis or rheumatoid arthritis	arthritis or rheumatoid arthritis
	of the trapeziometacarpal joint	of the trapeziometacarpal joint
	localized pain and palpable	localized pain and palpable
	crepitation during circumduction	crepitation during circumduction
	with axial compression of the	with axial compression of the
	thumb	thumb
	loss of thumb motion, decrease	loss of thumb motion, decrease
	of normal pinch and grip	of normal pinch and grip
	strength	strength
	radiological evidence of arthritic	radiological evidence of arthritic
	changes of the	changes of the
	trapeziometacarpal,	trapeziometacarpal,
	trapezioscaphoid,	trapezioscaphoid,
	trapeziotrapezoid and trapezium	trapeziotrapezoid and trapezium
	second metacarpal joints, singly	second metacarpal joints, singly
	or in combination	or in combination
	unstable, stiff, or painful distal	unstable, stiff, or painful distal
	joint of the thumb or swan-neck	joint of the thumb or swan-neck
	deformity	deformity
	old Bennett fracture	old Bennett fracture
	Use	Single use
	Fixation	stem in intramedulary canal
	Constraint	non constrained
	Material	Silicone Elastomer
	Sizes	3 sizes, 10, 20, 30

Similarities of the Avanta Orthopaedics Trapezium Implant and the Dow Corning Corporation Swanson Trapezium 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 metacarpal bone of the thumb and replace the trapezium bone of the wrist;

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

Both devices are comparably sized in diameter;

Both devices have the same indications for use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and features the department's name around the perimeter. In the center is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 1997

Ms. Louise M. Focht Vice President, Research and Development Avanta Orthopaedics 9369 Carroll Park Drive, Suite A San Diego, California 92121

Re : K965204 Trade Name: Avanta Orthopaedics Trapezium Implant Regulatory Class: II Product Code: KYI Dated: March 20, 1997 Received: March 21, 1997

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, Druq, and Cosmetic Act (Act). 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, qood 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will

{3}------------------------------------------------

Page 2 - Ms. Louise M. Focht

verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements 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.

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 yitro 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,

C. Celia M. Witten, Ph.D., M.

ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

{4}------------------------------------------------

Device Intended Use

Avanta Orthopaedics Trapezium Implant may be considered for use in thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows:

Localized pain and palpable crepitation during circumduction movements with axial . compression of the thumb.
Loss of the thumb motion with decrease of normal pinch and grip strength. .
Radiological evidence of arthritic changes of the trapeziometacarpal joint, trapeziotrapezoid . and trapezium second metacarpal joint, singly or in combination.
Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity. .
Following an old Bennet fracture. .

Prescription Use
(Per 21 CFR 801.109)

P. CODD

Divis Division of General Restorative 510(k) Number

Regulation Number and Section

§ 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.