BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM

K012184 · Blackstone Medical, Inc. · KWQ · Jan 30, 2002 · Orthopedic

Device Facts

• Record ID: K012184
• Device Name: BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
• Applicant: Blackstone Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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); f) tumor; g) pseudarthrosis; h) revision of previous surgery

Device Story

Titanium alloy anterior cervical plating system; consists of plates, screws, and associated surgical instrumentation. Used by surgeons for anterior fixation of cervical spine (C2-C7). Components implanted during surgery to stabilize vertebral bodies. Provides structural support to facilitate fusion or stabilization in patients with degenerative, traumatic, or neoplastic conditions. System is non-sterile and single-use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy; non-sterile; single-use; plates and screws; manual surgical instrumentation; mechanical fixation.

Indications for Use

Indicated for anterior cervical spine fixation (C2-C7) in patients with degenerative disc disease, spondylolisthesis, fracture, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or requiring 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

• Aesculap® ABC Cervical Plating System (K000486)
• Blackstone™ Anterior Cervical Plate System (K974885)
• Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (K971883)
• Danek ZEPHIR™ Anterior Cervical Plate System (K994239)

Submission Summary (Full Text)

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K02184 P1/2

JAN 3 0 2002

Premarket Notification Blackstone Medical, Inc. Blackstone™ III® Anterior Cervical Plating System 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™ III° Anterior Cervical Plating System |
| Common Name: | Cervical Plating Instrumentation |
| Device Product Code<br>& Classification: | KWQ 888.3060 - Spinal Intervertebral Body Fixation<br>Orthosis |

# Substantially

Equivalent Devices:

Aesculap® ABC Cervical Plating System (K000486) Blackstone™ Anterior Cervical Plate System (K974885) Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (K971883) Danek ZEPHIR™ Anterior Cervical Plate System (K994239)

### Device Description:

The Blackstone™ III° Anterior Cervical Plating System 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:

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;
- fracture; c)
- d) spinal stenosis; .
- e) deformities (i.e., scoliosis, kyphosis, and/or lordosis);

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K012184 p\$\frac{4}{2}\$

Premarket Notification Blackstone Medical, Inc. Blackstone™ III° Anterior Cervical Plating System Confidential

f) tumor;

g) pseudarthrosis;

h) revision of previous surgery

# BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ III° Anterior Cervical Plating System by its very nature is The "Diackstone" - " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "

Aesculap® ABC Cervical Plating System (K000486) Accemap® Insterior Cervical Plate System (K974885) Blackstone ... Anterior Corvical Prate Systems (2) ... ) ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (K971883) (K971605)
Danek ZEPHIR™ Anterior Cervical Plate System (K994239)

The FDA has cleared each of these devices, for anterior fixation to the cervical spine from C2 to C7.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2002

Mr. Alan Lombardo Director Engineering Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104

Re: K012184

> Device/Trade Name: Blackstone™ IIIo Anterior Cervical Plating System Regulatory Number: 21 CFR 888.3060 Regulatory Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 10, 2001 Received: June 12, 2001

Dear Mr. Lombardo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, 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 (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 (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 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.

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Page 2 – Mr. Alan Lombardo

This letter will allow you to begin marketing your device as described in your 510(k) prematet I mis letter will anow you to begin marketing your device to a legally marketed notification. The PDA incing of successification 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 and II you desire specific advice to your actives), please contact the Office of Compliance at additionally 809.10 for m Vito diagnostions on the promotion and advertising of your device, [phone]. Addinomally, for questions on as p-4639. Also, please note the regulation prease contact the Office of Compilance as (21 CFR 807.97). Other general entitled, "Misoranuming of received to pearned from the Act may be obtained from the Division of Small information on your responsibilities ander the rise may of 30-2041 or at [phone], or at its Internet address "http://www.fda.gov/cdrh/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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Page 1 of 1

market Notification Blackstone Medical, Inc. Blackstone™ III° Anterior Cervical Plating System Confidential

# 510(k) Number: ΚΟΙ 2 184

Device Name: Blackstone™ III° Anterior Cervical Plating System

# Indications for Use:

Blackstone™ III° Anterior Cervical Plating System is intended for anterior fixation to Diaenovical 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);
- spondylolisthesis; b)
- c) fracture;
- d) spinal stenosis;
- deformities (i.e., scoliosis, kyphosis, and/or lordosis); e)
- 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)

for Mark N. Mulkern

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

510(k) Number K012184