UNIVERSITY PLATE ANTERIOR SYSTEM

K980228 · Acromed Corp. · KWQ · Apr 14, 1998 · Orthopedic

Device Facts

• Record ID: K980228
• Device Name: UNIVERSITY PLATE ANTERIOR SYSTEM
• Applicant: Acromed Corp.
• Product Code: KWQ · Orthopedic
• Decision Date: Apr 14, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The University M Plate™ Anterior System is intended for lateral screw fixation to the T9-L4 levels of the spine, and is not suitable for attachment to the sacrum. Specific indications are fracture, tumor, previous failed fusion and pseudoarthrosis, and degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

Device Story

Spinal intervertebral body fixation system; provides stabilization via titanium alloy plates and screws. Plates feature contoured low-profile design for lateral thoracolumbar vertebral bodies; slot pattern allows variable screw/bolt placement; spherical countersinks permit 15-degree screw angulation. Distally tapered plates accommodate iliac vessels at L4. System includes drill guide for precise vertebral drilling and sizing. Used by surgeons in clinical/OR settings to treat spinal pathologies. Output is mechanical stabilization of vertebral segments. Benefits include structural support for fusion and pain reduction in degenerative disc disease.

Clinical Evidence

Bench testing only. Static and fatigue testing performed to demonstrate mechanical performance consistent with predicate devices.

Technological Characteristics

Materials: ASTM F-136 titanium alloy. Components: Plates (rectangular or distally tapered), 7.0mm bolts, 6.25mm screws. Features: Low-profile contouring, spherical countersinks for 15-degree angulation, drill guide template. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring lateral screw fixation at T9-L4 spinal levels for fracture, tumor, previous failed fusion, pseudoarthrosis, or degenerative disc disease. Not for sacral attachment.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• CASF™ Contoured Anterior Spinal Fixation System (K904446)
• Kaneda Anterior Spinal Multisegmental Fixation Device (K923703)
• ISOLA Anterior Spinal System (K943819)

Submission Summary (Full Text)

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APR 1 4 1998

K980228

## AcroMed UniversityAM Plate™ Anterior System 510(k) SUMMARY

UniversityAM Plate™ Anterior System

AcroMed Corporation COMPANY: 3303 Carnegie Avenue Cleveland, OH 44115

Spinal Intervertebral Body Fixation Orthosis CLASSIFICATION: Class II

DESCRIPTION:

TRADENAME:

University AM PlaterM Anterior System Plates: The UniversityAM Plate™ Anterior System plates are fabricated from ASTM F-136 implant grade titanium alloy. The plates have a contoured low profile to match the curvature of the lateral aspect of the thoracolumbar vertebral bodies. The slot pattern allows a wide range of serews and bolt placement, while the spherical countersinks allow up to 15 degrees of screw angulation. The University AM Plate™ Anterior System plates are either

rectangular or distally tapered, and come in a variety of lengths. Distally tapered plates are used at the L4 level to allow the common iliac vessels to cross without undue pressure.

The University AN Plate™ Anterior System Bolts and Screws: The University AM Plate™ Anterior System screws are fabricated from ASTM F-136 implant grade titanium alloy. Bolts are 7.0mm in diameter and screws are 6.25mm in diameter. Bolts and screws are available in 5mm length increments. When inserted, the tip of each bolt or screw should extend one thread through the opposite cortex of the vertebra to increase holding power.

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The University (M Plate™ Anterior System Drill Guide: The UniversityAM Plate™ Anterior System Drill guide is designed to allow precise drilling of the vertebral bodies and to act as a sizing Serious vascular or neurological template for the plates. complications may occur if the drill guide is not used. (See Precautions).

The components of the University AM Plate™ Anterior System are MATERIAL: manufactured from titanium alloy conforming to ASTM F-136 specifications.

INDICATIONS: The University AM Plate™ Anterior System is intended for lateral screw fixation to the T9-L4 levels of the spine, and is not suitable for attachment to the sacrum. Specific indications are fracture, tumor, previous failed fusion and pseudoarthrosis, and degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

## PERFORMANCE DATA:

Static and fatigue testing show the University AN Plate™ Anterior System to perform consistently with previously cleared components.

## SUBSTANTIAL EQUIVALENCE:

The UniversityAM Plate™ Anterior System is substantially equivalent to the CASF™ Contoured Anterior Spinal Fixation System as cleared under K904446, the Kaneda Anterior Spinal Multisegmental Fixation Device as cleared under K923703 and the ISOLA Anterior Spinal System as cleared under K943819.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 1998

Mr. William Christianson ·Vice President, Regulatory Affairs AcroMed® Corporation 3303 Carnegie Avenue Cleveland, Ohio 44115

Re : K980228 University Ad Plate™ Anterior System Requlatory Class: II Product Code: KWQ Dated: January 20, 1998 January 22, 1998 Received:

Dear Mr. Christianson:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act You may, therefore, market your device system subject (Act) . . to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501 (f) (1) of the Act.

FDA identifies that any device system, if intended for use in pedicular screw fixation/attachment, except for some limited indications, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

- You may not label or in any way promote this device 1. system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the

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package insert must include the following statement, This device system is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.";

- All labeling for this device system, including the 2. package label, must state that there are labeling limitations. The package insert must prominently state that the device system is intended for the specific use(s) described in the enclosure only; and
- Pedicular screw fixation/attachment to the cervical, 3. thoracic or lumbar vertebral column, except for limited indications, of any device system is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under All users of the device system for 21 CFR, Part 812. pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.

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 Regulations, Title 21, Parts 800 to 895. ಗ್ಗೆ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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.

FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new 510 (k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the

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Page 3 - Mr. William Christianson

subject device components and other device components, whether yours or other manufacturers', may also be required.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Stephen Rhodes

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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510(k) Number (if known): _

UniversityAM Plate™ Anterior System Device Name:

Indications for Use:

The University M Plate™ Anterior System is intended for lateral screw fixation to the T9-L4 levels of the spine, and is not suitable for attachment to the sacrum. Specific indications are fracture, turnor, previous failed fusion and pseudoarthrosis, and degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

4980228

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span></span> |
|----------------------|---------------|
| (per 21 CRF 801.109) | <span></span> |

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Stephen Rlevels

(Division Sign-Off)
Division of General RestK980228
510(k) Number.