BLACKSTONE POSTERIOR CERVICAL SYSTEM

K030197 · Blackstone Medical, Inc. · KWP · Jun 12, 2003 · Orthopedic

Device Facts

• Record ID: K030197
• Device Name: BLACKSTONE POSTERIOR CERVICAL SYSTEM
• Applicant: Blackstone Medical, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jun 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone™ Posterior Cervical System is indicated for: - a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) - b) spondylolisthesis - c) spinal stenosis - d) fracture/dislocation - e) atlantoaxial fracture with instability - occipito-cervical dislocation f) - g) revision of previous cervical spine surgery - h) tumors The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. The Songer Cable System to be used with the Blackstone™ Posterior Cervical System allows for wire/cable attachment to the posterior cervical spine.

Device Story

Titanium alloy spinal instrumentation system; components include rods, set-screws, cross connectors, multi-axial screws, plates, bone screws, and Songer Cables. Used by surgeons to build spinal implant constructs for posterior fixation. Multi-axial screws limited to upper thoracic spine (T1-T3); occipital screws limited to occipital fixation. Provides stabilization to promote fusion in cervical and occipito-cervico-thoracic regions. Non-sterile, single-use components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy construction; non-sterile, single-use components. System includes rods, set-screws, cross connectors, multi-axial screws, plates, bone screws, and cables. Mechanical fixation system for spinal stabilization.

Indications for Use

Indicated for patients requiring spinal fusion at the cervical spine and occipito-cervico-thoracic junction (occiput-T3) due to degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision surgery, or tumors. Occipital screws restricted to occipital fixation; multi-axial screws restricted to T1-T3 thoracic placement.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• DePuy AcroMed™, Summit (OTC) Spinal System (K002733)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUN 1 2 2003

Premarket Notification Blackstone Medical, Inc. Blackstone™ Posterior Cervical System Confidential

#### 1630197 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Name of Firm: | Blackstone Medical, Inc. 90 Brookdale Drive Springfield, MA 01104 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Contact Person: Dean Ciporkin Director of Regulatory Affairs & Quality Assurance |
| Trade Name: | Blackstone™ Posterior Cervical System |
| Common Name: | Rod and screw spinal instrumentation |
| Device Product Code<br>& Classification: | MNI - 888.3070 - Pedicle Screw Spinal System KWP - 888.3050 - Spinal Interlaminal Fixation Orthosis |
| Substantially<br>Equivalent Devices: | DePuy AcroMed™, Summit (OTC) Spinal System (K002733 |

#### Device Description:

The Blackstone™ Posterior Cervical System is a titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The Blackstone™ Posterior Cervical System consists of an assortment of rods, set-screws, cross connectors, multi-axial screws, plates, bone screws and Songer Cables.

### Intended Use / Indications for Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone™ Posterior Cervical System is indicated for:

- a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- b) spondylolisthesis
- c) spinal stenosis
- d) fracture/dislocation
- e) atlantoaxial fracture with instability
- occipito-cervical dislocation f)
- g) revision of previous cervical spine surgery
- h) tumors

The occipital bone screws are limited to occipital fixation only.

Summary

3)

{1}------------------------------------------------

Premarket Notification Blackstone Medical, Inc. Blackstone™ Posterior Cervical System Confidential

The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System to be used with the Blackstone™ Posterior Cervical System allows for wire/cable attachment to the posterior cervical spine.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ Posterior Thoracic System by its very nature is substantially equivalent to the DePuy AcroMed™, Summit (OTC) Spinal System (K002733) which has been cleared by FDA for posterior fixation applications to the occipito-cervico-thoracic junction (occiput -T3).

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right, stacked on top of each other.

JUN 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dean E. Ciporkin Director, Regulatory Affairs and Quality Assurance Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104

Re: K030197

Trade Name: Blackstone™ Posterior Cervical System Regulation Number: 21 CFR 888.3050, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, MNI Dated: May 14, 2003 Received: May 15, 2003

Dear Mr. Ciporkin:

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, 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 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. Dean E. Ciporkin

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 [phone]. 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 vours.

Sincerely yours,

Mark N. Millman

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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#### 030197

## 510(k) Number: 022220000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

## Device Name: Blackstone™ Posterior Cervical System

#### Indications for Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic When Intended to promote fusion of the oce near ophis and overple of hos on

- a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- b) spondylolisthesis
- c) spinal stenosis
- d) fracture/dislocation
- e) atlantoaxial fracture with instability
- occipito-cervical dislocation f)
- g) revision of previous cervical spine surgery
- h) tumors

The occipital bone screws are limited to occipital fixation only.

The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System to be used with the Blackstone™ Posterior Cervical System allows for wire/cable attachment to the posterior cervical spine.

Concurrence of CDRH, Office of device Evaluation


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

| 510(k) Number | K030197 |
|---------------|---------|
|---------------|---------|

| Prescription Use | OR | Over-The-Counter Use |
|------------------|----|----------------------|
|------------------|----|----------------------|

(Per 21 CFR801.109)