AESCULAP ABC CERVICAL PLATING SYSTEM

K974706 · Aesculap, Inc. · KWQ · Mar 13, 1998 · Orthopedic

Device Facts

• Record ID: K974706
• Device Name: AESCULAP ABC CERVICAL PLATING SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 13, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discongenic pain with generation of the disc confirmed by history and radiographic studies), trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions through anterior cervical intervertebral body screw fixation. Levels of screw fixation for this indication are from C2 to T4.

Device Story

The ABC Cervical Plating System is an anterior cervical intervertebral body fixation orthosis. It consists of plates and screws used by surgeons to stabilize the cervical spine (C2-T4) in patients with instability from degenerative disease, trauma, tumors, or failed fusions. The system provides mechanical stabilization through anterior screw fixation. It is intended for use in a clinical/surgical setting. The device is not approved for posterior pedicular screw fixation. The system is designed to provide structural support to the spine, potentially reducing pain and improving stability for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Anterior cervical spine plating system consisting of plates and screws. Class II spinal intervertebral body fixation orthosis. Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for patients with cervical spine instability due to degenerative disc disease, trauma (fractures), post-traumatic kyphosis/lordosis, tumors, or failed previous fusions. Fixation levels C2-T4. Contraindicated for pedicular screw fixation/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.

Submission Summary (Full Text)

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ABC Cervical Plating System

Amendment #1 to #K974706

L474706

# 510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990 Aesculap ABC Cervical Plating System

MAR 1 3 1998

Submitted: December 15, 1997

by: Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Lia Spasaro Phone: [phone] x 350 FAX: [phone]

### Product

Aesculap ABC Cervical Plating System

### Common Names

Anterior Cervical Spine Plates and Screws

### Classification Names and Product Codes

KWQ - Spinal Intervertebral Body Fixation Orthosis

### Product Classification

Class II

# Regulatory Classification

21 CFR Section 888,3060 Spinal Intervertebral Body Fixation Orthosis

#### Intended Use

The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discongenic pain with generation of the disc confirmed by history and radiographic studies), trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions through anterior cervical intervertebral body screw fixation. Levels of screw fixation for this indication are from C2 to T4.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 1998

Ms. Lia Spasaro Jones Regulatory Associate Aesculap, Inc. 1000 Gateway Boulevard South San Francisco, California 94080-7030

Re: K974706 ABC Cervical Plating System Regulatory Class: II Product Code: KWO Dated: December 15, 1997 Received: December 16, 1997

#### Dear Ms. Jones:

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 (Act). You may, therefore, market your device system subject 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:

- 1 . You may not label or in any way promote this device 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 package insert must include the following statement, "WARNING: This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.";

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#### Page 2 - Ms. Lia Spasaro Jones

- All labeling for this device system, including the package label, must state that there 2. 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, thoracic or lumbar vertebral 3. 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 21 CFR. Part 812. All users of the device system for 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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.

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 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 regulation (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

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Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], 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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Amendment #1 to #K974706

ABC Cervical Plating System

Page 1 of 1

# INDICATION FOR USE STATEMENT

510(k) Number (if known):

K974706

Device Name:

Aesculap ABC Cervical Plating System

### Indication for Use:

The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discongenic pain with generation of the disc confirmed by history and radiographic studies), trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions through anterior cervical intervertebral body screw fixation. Levels of screw fixation for this indication are from C2 to T1.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(per 21 CFR 801.109) | <div></div> |
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| (Optional Format 1-2-96) | <div></div> |
| Division of General Restorative Devices | <div></div> |
| 510(k) Number | K974706 |