← Product Code [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ) · K072650

# IST ANTERIOR CERVICAL PLATE SYSTEM (K072650)

_Innovative Spinal Technologies, Inc. · KWQ · Nov 28, 2007 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K072650

## Device Facts

- **Applicant:** Innovative Spinal Technologies, Inc.
- **Product Code:** [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ.md)
- **Decision Date:** Nov 28, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3060
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: - Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies) - Spondylolisthesis . - Trauma (i.e., fractures or dislocations) . - Tumors . - Deformity (defined as kyphosis, lordosis, or scollosis) . - Pseudoarthrosis . - Failed previous fusions .

## Device Story

IST Anterior Cervical Plate System consists of titanium alloy plates of varying lengths; used for anterior screw fixation to C2-C7 cervical spine levels. Device provides temporary stabilization during cervical spinal fusion. Intended for use by surgeons in clinical settings. System components provided clean and non-sterile; requires steam sterilization at user facility. Mechanical performance validated via ASTM F1717 testing.

## Clinical Evidence

Bench testing only. Mechanical test results based on ASTM F1717 demonstrate substantial equivalence to predicate devices.

## Technological Characteristics

Titanium alloy construction; various lengths to accommodate patient anatomy; steam sterilization required; mechanical performance validated per ASTM F1717.

## Regulatory 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

- X-Spine Anterior Compact Plate (ACP) System ([K041469](/device/K041469.md))
- Synthes CSLP System ([K926453](/device/K926453.md), [K945700](/device/K945700.md) and [K030866](/device/K030866.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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K072650

## Attachment 2: 510(k) Summary

| DATE:                      | November 21, 2007                                                                                                                   |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER:                 | Innovative Spinal Technologies, Inc.<br>111 Forbes Boulevard<br>Mansfield, MA 02048<br>Telephone: 508/452-3500<br>Fax: 508/452-3600 |
| CONTACT PERSON:            | Gina Yeh<br>Manager, Regulatory Affairs                                                                                             |
| TRADE NAME:                | IST Anterior Cervical Plate System NOV 28 2007                                                                                      |
| FDA CLASSIFICATION / CODE: | 888.3060 / KWQ                                                                                                                      |

DEVICE DESCRIPTION: The IST Anterior Cervical Plate is made of titanium alloy. The plate is offered in various lengths to meet individual patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

INTENDED USE: The IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

- Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
- Spondvlolisthesis .
- Trauma (i.e., fractures or dislocations) .
- Tumors .
- Deformity (defined as kyphosis, lordosis, or scollosis) .
- Pseudoarthrosis .
- Failed previous fusions .

PREDICATE DEVICES: The predicate devices include: X-Spine Anterior Compact Plate (ACP) System (K041469) and Synthes CSLP System (K926453, K945700 and K030866)

PERFORMANCE DATA: The mechanical test results based on ASTM F1717 demonstrate that the IST ACP System can be expected to perform in a manner substantially equivalent to the predicate devices for purposes of safety and effectiveness.

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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 features the department's name in a circular arrangement around a symbol. The symbol is a stylized depiction of a human figure, with three faces overlapping to represent the department's focus on health and human well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2007

Innovative Spinal Technologies % Ms. Gina Yeh Manager, Regulatory Affairs 111 Forbes Blvd. Mansfield, Massachusetts 02048

K072650 Re:

Trade/Device Name: IST Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 18, 2007 Received: September 19, 2007

Dear Ms. Yeh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use surver in the encreated) 70 the enactment date of the Medical Device Amendments, or to commerce pror to 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). who cosmette for (110) was the device, subject to the general controls provisions of the Act. The I ou may, therefore, mains 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 thay be subject to basil addess a cegulations, 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 be actived that the reading 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 Of A rat 0077) woods (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product in 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

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Page 2 - Ms. Gia Yeh

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Mulhausen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 3: Instructions for Use

## Indication for Use Statement

510(k) Number: K072650 and the control of the control of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution

Device Name: IST Anterior Cervical Plate System

Indications:

The IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

- Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
- Spondylolisthesis .
- Trauma (i.e., fractures or dislocations) .
- Tumors .
- Deformity (defined as kyphosis, lordosis, or scoliosis) .
- Pseudoarthrosis .
- Failed previous fusions .

Prescription Use _ _ X _______________________________________________________________________________________________________________________________________________________ e for a commission (21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH/Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K072650 |
|---------------|---------|
|---------------|---------|

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K072650](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K072650)

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