BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)

K033980 · Blackstone Medical, Inc. · KWP · Mar 3, 2004 · Orthopedic

Device Facts

• Record ID: K033980
• Device Name: BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)
• Applicant: Blackstone Medical, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Mar 3, 2004
• Decision: SESE
• Submission Type: Special
• 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 Ascent Posterior Occipital Cervical Thoracic System is indicated for: a) Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies: b) Spondylolisthesis; c) Fracture/dislocation; d) Spinal stenosis; e) Atlanto-axial fracture with instability; f) Occipito-cervical dislocation; g) Tumors; h) Revision of previous cervical spine surgery The occipital bone screws are limited to occipital fixation only. The use of the multiaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The hooks are intended to be placed from C1 to T3. The Songer Cable (titanium) System to be used with the Blackstone Ascent Posterior Occipital Cervical Thoracic System allows for wire/cable attachment to the posterior cervical spine.

Device Story

Titanium alloy spinal instrumentation system; components include rods, setscrews, cross connectors, multi-axial screws, plates, bone screws, hooks, and Songer cables. Used by surgeons in clinical settings to build spinal implant constructs for immobilization and stabilization as an adjunct to fusion. Hooks integrate with existing Blackstone Ascent POCT system components. Provides mechanical support to the posterior cervical and upper thoracic spine; facilitates bone fusion; stabilizes spinal segments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy construction; multi-component spinal fixation system; includes rods, screws, hooks, and cables. Designed for posterior occipital-cervical-thoracic (occiput-T3) fixation. Non-sterile, single-use components.

Indications for Use

Indicated for patients requiring spinal fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) due to degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto-axial fracture with instability, occipito-cervical dislocation, tumors, or revision of previous cervical spine surgery. Hooks are indicated for C1-T3 placement; multi-axial screws are limited to T1-T3 thoracic conditions; occipital screws are limited to occipital fixation.

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

• Blackstone™ Ascent POCT System (K030197)

Submission Summary (Full Text)

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Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone™ Ascent Posterior Occipital-Cervical-Thoracic System Hooks (System Modification)

K033980
Page 1 of 2

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### 510(K) SUMMARY

| Name of Firm: | Blackstone Medical, Inc.<br>90 Brookdale Drive<br>Springfield, MA 01104 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Dean E. Ciporkin<br>Director, Regulatory Affairs and Quality Assurance |
| Trade Name: | Blackstone™ Ascent POCT System Hooks |
| Common Name: | Rod and screw spinal instrumentation |
| Device Product Code<br>& Classification: | MNI - 888.3070 - Pedicle Screw Spinal System<br>KWP- 888.3050 - Spinal Interlaminal Fixation Orthosis |
| Substantially<br>Equivalent Devices: | Blackstone™ Ascent POCT System (K030197) |

#### Device Description:

MAR - 3 2004

The Blackstone™ Ascent POCT 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 system's design is intended promote immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine. The Blackstone™ Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, multi-axial screws, plates, bone screws, and Songer Cables. The hooks are designed to be compatible with and work in conjunction with the components in the current Blackstone Ascent POCT System.

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Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone™ Ascent Posterior Occipital-Cervical-Thoracic System Hooks (System Modification)

> K033480 Page 2 of 2

### Intended Use / Indications for Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone™ Ascent POCT 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) atlanto/axial fracture with instability
- occipitocervical dislocation f)
- g) revision of previous cervical spine surgery
- h) tumors

The occipital bone screws are limited to occipital fixation only.

The hooks placement is indicated from C1-T3.

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™ POCT System allows for wire/cable attachment to the posterior cervical spine.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ Ascent POCT System Hooks are substantially equivalent to the Blackstone Ascent POCT System (K030197), which has been cleared by FDA for posterior fixation applications to the occipito-cervico-thoracic junstion (occiput-T3)

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with three wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 2004

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

Re: K033980

Trade/Device Name: Blackstone™ Ascent Posterior Occipital-Cervical-Thoracic System Regulation Number: 21 CFR 888.3050; 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis; Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNI Dated: December 1, 2003 Received: December 29, 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 may or career to one 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 or any I 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 5 10(k) This letter will allow you to ocgin marketing your antial equivalence of your device to a legally premarket notification. The PDA midning of backandal expand 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 entiled If you desire specific advice for your ac not on one of the regulation entitled.
contact the Office of Compliance at [phone]. Also, please note the regulation contact the Office of Compliance at (301) 37 - 1007 (21 CFR Part 807.97). You may obtain "Misbranding by reference to premation inclification of Street the Act from the Division of Small other general Information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at the local demoments http:// Manufacturers, International and Collisaner Piscessor.cdrb/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Witten, Ph.D., M.D. Celia Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number: K033980

Page 1 of 1

# Device Name: Blackstone™ Ascent Posterior Occipital-Cervical-Thoracic System

### Indications for Use:

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

- a) Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies:
- b) Spondylolisthesis;
- c) Fracture/dislocation;
- d) Spinal stenosis;
- e) Atlanto-axial fracture with instability;
- f) Occipito-cervical dislocation;
- g) Tumors;
- h) Revision of previous cervical spine surgery

The occipital bone screws are limited to occipital fixation only. The use of the multiaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine.

The hooks are intended to be placed from C1 to T3.

The Songer Cable (titanium) System to be used with the Blackstone Ascent Posterior Occipital Cervical Thoracic System allows for wire/cable attachment to the posterior cervical spine.

## (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

| Prescription Use | X |
|---------------------|----------------------|
| (Per 21 CFR801.109) | |
| 510(k) Number | K035980 |
| | Over-The-Counter Use |