The Wafer System, in conjunction with commercially available supplemental fixation, is intended for use in proximal tibial opening wedge osteotomies as a means to restore anatomical alignment and relative position.

Device Description

The Wafer System consists of a delivery gun, a delivery track and a wafer cartridge assembly. The Wafers are used to open the osteotomy and act as a spacer until bone graft and supplemental fixation can be placed. The Wafer System Implants are manufactured from Polyetheretherketone (PEEK) with 6% Barium Sulfate.

AI/ML Overview

The provided text describes the "Wafer System," an orthopedic device, and details its 510(k) submission. However, it does not contain information about acceptance criteria, device performance studies to meet those criteria, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance) as requested.

The document primarily focuses on:

Submitter and Device Information: Company name, contact, product name, common name, classification.
Device Description: Components (delivery gun, delivery track, wafer cartridge assembly, PEEK wafers with Barium Sulfate).
Intended Use: Proximal tibial opening wedge osteotomies, in conjunction with supplemental fixation, to restore anatomical alignment and relative position.
Substantial Equivalence: To Arthrex Opening Wedge Osteotomy System (K973812) and Synthes Spiked Washer (K011583).
Mechanical Testing: A brief mention that "mechanical testing demonstrated that The Wafer System met the performance requirements for its intended use." No details of these tests, specific criteria, or results are provided.
FDA Approval Letter: A standard FDA 510(k) clearance letter.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance study details from the provided text. The document only confirms the device's clearance based on substantial equivalence and a general statement about mechanical testing.

Summary

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JUN 2 4 2004

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Ka33303

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Image /page/0/Picture/2 description: The image shows the words "Spine Wave, Inc." in a bold, italicized font. The text is black and appears to be slightly distressed, giving it a textured look. The words are arranged horizontally, with "Spine Wave" on the first line and "Inc." on the second line.

510(k) Summary The Wafer System™

Submitter Information: I.

Submitter's Name:	Spine Wave, Inc.
	Two Enterprise Drive
	Suite 302
	Shelton, CT 06484
Telephone:	203-944-9494
Telefax:	203-944-9493

Contact:	Ronald K. Smith
Date Prepared:	October 13, 2003

II. Device Information

Trade name:	The Wafer System
Common name:	Wedge Osteotomy Spacer
Classification name:	Plate, Fixation, Bone

III. Device Description

The Wafer System Implants are manufactured from Polyetheretherketone (PEEK) with 6% Barium Sulfate.

Intended Use IV.

V. Substantial Equivalence

The Wafer System was demonstrated to be substantially equivalent to the Arthrex Opening Wedge Osteotomy System (K973812) and the Synthes Spiked Washer (K011583). In addition, mechanical testing demonstrated that The Wafer System met the performance requirements for its intended use. Dissimilarities between The Wafer System and the predicate devices do not affect the safety or effectiveness of this device.

Two Enterprise Drive Suite 302 Shelton, CT 06484

Phone: 203-944-9494 Fax: 203-944-9493

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an emblem featuring a stylized eagle with three lines representing the department's mission. The eagle is facing right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2004

Ronald K. Smith Spine Wave, Inc. Two Enterprise Drive, Suite 302 Shelton, Connecticut 06484

Re: K033303 Trade/Device Name: The Wafer System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: March 25, 2004 Received: March 26, 2004

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren on (2) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to tegans and date of the Medical Device Amendments, or to conniner to May 2011/2017 11:51 accordance with the provisions of the Federal Food, Drug, de vices that have been recure approval of a premarket approval application (PMA). and Cosmette rest (rec) that ao nov requently subject to the general controls provisions of the Act. The r ou may, merelore, mainer of the Act include requirements for annual registration, listing of general controls provisions 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 If your device to such additional controls. Existing major regulations affecting your device can may be 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 r lease of advised that I Dris brounder of our device complies with other requirements of the Act that I Dri has made a cond regulations administered by other Federal agencies. You must or any I odetar station and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IN art 607), idooing (21 CFR Part 820); and if applicable, the electronic form in the quality by events (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin makemig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial end thus, permits your premarket notification. The PDA miding of satstantal equal 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 If you desire specific advice for your ac 110 % - 659. Also, please note the regulation entitled, and contact the Office of Complance at (501) 59 1799 - 1097 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Pat 807.97). You ma " Misbranding by reference to premanst noulities under the Act from the Division of Small
other general information on your responsibilities under the Act from the (800) 638other general information on your responsible in toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance and Children (department) attrack Manufacturers, micritational and Ochbankt Provinces of the Constant of the main.html

Sincerely yours,

Mark A. 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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Page _ 1 _ of_ 1

510(k) Number (if known): Ko 33303

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office Of Device Evaluation (ODE)

	Mark N Millenn

for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number	K033303
----------------------	---------

Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

000121

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.