BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE

K022965 · Blackstone Medical, Inc. · KWQ · Mar 28, 2003 · Orthopedic

Device Facts

• Record ID: K022965
• Device Name: BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE
• Applicant: Blackstone Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Blackstone Medical Inc. "Classic" Anterior Cervical Plate is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: a) degenerative disc disease (ddd)* * As defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies: b) spondylolisthesis; c) fracture; d) spinal stenosis: e) deformities (i.e., scoliosis, kyphosis, and/or lordosis); tumor; f) g) pseudoarthrosis; h) revision of previous surgery

Device Story

Titanium alloy anterior cervical plating system; consists of plates, screws, and surgical instrumentation. Used for temporary internal fixation of cervical spine (C2-C7). Implanted by surgeons during spinal procedures to stabilize vertebral bodies. Provides structural support to facilitate fusion; assists in correcting deformities or stabilizing fractures/degenerative conditions. Single-use, non-sterile components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy; multiple component system; non-sterile; single-use; plates and screws for anterior cervical fixation.

Indications for Use

Indicated for patients requiring anterior cervical spine fixation (C2-C7) for degenerative disc disease, spondylolisthesis, fracture, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision surgery.

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

• Blackstone™ III° Anterior Cervical Plating System (K012184)
• Blackstone™ Anterior Cervical Plate System (K974885)

Submission Summary (Full Text)

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K 0 2 2 9 6 5

MAR 2 8 2003

Premarket Notification Blackstone Medical, Inc. Blackstone ™ "Classic" Anterior Cervical Plate Confidential

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Name of Firm: | Blackstone Medical, Inc.<br>90 Brookdale Drive<br>Springfield, MA 01104 |
|---------------------------------------|-------------------------------------------------------------------------|
| 510(k) Contact: | Alan Lombardo<br>Director of Engineering |
| Trade Name: | Blackstone™ "Classic" Anterior Cervical Plate |
| Common Name: | Cervical Plating Instrumentation |
| Device Product Code & Classification: | KWQ 888.3060 - Spinal Intervertebral Body Fixation<br>Orthosis |

## Substantially

Equivalent Devices:

Blackstone™ III° Anterior Cervical Plating System (K012184) Blackstone™ Anterior Cervical Plate System (K974885)

## Device Description:

The Blackstone™ "Classic" Anterior Cervical Plate is a titanium alloy; multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.

## Intended Use / Indications for Use:

The Blackstone Medical Inc. "Classic" Anterior Cervical Plate is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

- a) degenerative disc disease (ddd)*
* As defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies:

- b) spondylolisthesis;
- c) fracture;
- d) spinal stenosis:
- e) deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- tumor; f)
- g) pseudoarthrosis;
- h) revision of previous surgery

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Premarket Notification Blackstone Medical, Inc. Blackstone ™ "Classic" Anterior Cervical Plate Confidential

# BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ "Classic" Anterior Cervical Plate System by its very nature is substantially equivalent to the Blackstone™ III° Anterior Cervical Plating System (K012184) and the Blackstone™ Anterior Cervical Plate System (K974885). The FDA has cleared this device, for anterior fixation to the cervical spine from C2 to C7.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing, ribbon-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

Mr. Alan Lombardo Vice President, Product Development Blackstone Medical Incorporated 90 Brookdale Drive Springfield, Massachusetts 01104

Re: K022965

> Trade Name: Blackstone "Classic" Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: January 2, 2003 Received: January 3, 2003

Dear Mr. Lombardo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 be found in the Code of Federal Regulations, 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 that FDA has made a determination 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 forth in the quality systems (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.

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Page 2 - Mr. Alan Lombardo

This letter will 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 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 Office of Compliance at (301) 594- . . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

sincerely, yours,

Mark McMullen

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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#### KO22965 510(k) Number:

## Device Name: Blackstone™ III° Anterior Cervical Plating System

## Indications for Use:

Blackstone™ III° Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

- a) degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- b) spondylolisthesis;
- c) fracture;
- d) spinal stenosis;
- e) deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- tumor; f)
- g) pseudarthrosis;
- h) revision of previous surgery

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Melkerson

Division of General. Rest ative and Neurological Devices

510(k) Number_

2296