MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM

K030241 · Blackstone Medical, Inc. · KWP · Feb 21, 2003 · Orthopedic

Device Facts

• Record ID: K030241
• Device Name: MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
• Applicant: Blackstone Medical, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Feb 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients: a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; b) Who are receiving fusion using autogenous bone graft only; c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and d) Who are having the device removed after the development of a solid fusion mass. The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: a) Degenerative spondylolistheses with objective evidence of neurologic impairment; b) Fracture; c) Dislocation; d) Scoliosis; e) Kyphosis; Spinal tumor; and f) g) Failed previous fusion (pseudarthrosis). The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies); b) spondylolistheses; c) spinal stenosis; d) spinal deformities (i.e., scoliosis, kyphosis, lordosis); e) tumor; pseudoarthrosis; f) g) previous failed fusion; and h) trauma (i.e., fracture or dislocation). The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies); b) spondylolistheses; c) spinal stenosis; d) spinal deformities (i.e., scoliosis, kyphosis, lordosis); e) tumor; pseudoarthrosis; f) g) previous failed fusion; and h) trauma (i.e., fracture or dislocation).

Device Story

Blackstone Spinal Fixation System is a non-sterile, single-use spinal instrumentation system; comprised of titanium alloy (6AL-4V ELI) rods, screws, hooks, and domino rod connectors. Used by surgeons in clinical settings to build spinal implant constructs for immobilization and stabilization of thoracic, lumbar, and sacral spine segments. Domino component allows intra-operative rod attachment for construct extension. System provides mechanical support as an adjunct to fusion; helps restore spinal alignment and stability in patients with deformities or instabilities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy (6AL-4V ELI, ASTM F136). Non-sterile, single-use components. Includes rods, screws, hooks, and domino rod connectors for spinal fixation.

Indications for Use

Indicated for non-cervical spinal stabilization/immobilization in skeletally mature patients. Conditions: degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, degenerative disc disease, spinal stenosis, lordosis, trauma. Pedicle screw use restricted to L3-S1 for severe spondylolisthesis (Grades 3-4) at L5-S1 with autogenous bone graft.

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™ Spinal Fixation System (K994217)
• Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screws (K020674)
• Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screws (K013558)
• Blackstone™ Spinal Fixation System 2nd Gen. Cross-Connector (K003735)
• Blackstone™ Spinal Fixation System Modified Multi-Axial Screws (K023498)
• Blackstone™ Spinal Fixation System Hooks (K013885)
• Blackstone™ Spinal Fixation System Spacers (K022399)
• Blackstone™ Spinal Fixation System Staple & Washer (K022605)

Reference Devices

• Danek device

Submission Summary (Full Text)

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# FEB 2 1 2003

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

| Name of Firm: | Blackstone Medical, Inc.<br>90 Brookdale Drive<br>Springfield, MA 01104 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Contact Person: Dean Ciporkin<br>Director of Regulatory Affairs & Quality Assurance |
| Trade Name: | Blackstone™ Spinal Fixation System<br>Spinal Fixation System<br>Domino |
| Common Name: | Rod and screw spinal instrumentation |
| Device Product Code<br>& Classification: | MNH – 888.3070 – Spondylolisthesis Spinal Fixation<br>Device System<br>KWQ – 888.3060 – Spinal Intervertebral Body Fixation<br>Orthosis<br>MNI – 888.3070 – Pedicle Screw Spinal System<br>KWP – 888.3050 – Spinal Interlaminal Fixation Orthosis |

#### Substantially

### Equivalent Devices:

Blackstone™ Spinal Fixation System (K994217) Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screws (K020674) Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screws (K013558) Blackstone™ Spinal Fixation System 2nd Gen. Cross-Connector (K003735) Blackstone™ Spinal Fixation System Modified Multi-Axial Screws (K023498) Blackstone™ Spinal Fixation System Hooks (K013885) Blackstone™ Spinal Fixation System Spacers (K022399) Blackstone™ Spinal Fixation System Staple & Washer (K022605)

## Device Description:

The Blackstone™ Spinal Fixation System is comprised of titanium alloy (6AL-4V ELI, per ASTM F136) devices in a variety of non-sterile, single use components. This system allows a surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws and hooks to the non-cervical spine.

The domino addition will function as a rod connector. There are clinical applications in which a surgeon will need to have the inter-operative ability to attach rods when extending a construct.

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KO30241 age 2 of 3

### Intended Use / Indications for Use:

The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:

- a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
- d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

- a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
- b) Fracture;
- c) Dislocation;
- d) Scoliosis;
- e) Kyphosis;
- Spinal tumor; and f)
- g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:

- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- c) spinal stenosis;
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor:
- pseudoarthrosis; f)
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation).

The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications:

- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- c) spinal stenosis;
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor;
- pseudoarthrosis; f)
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation).

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K030241
Page 3 of 3

# BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ Domino by its very nature are substantially equivalent to the Danek device which has been cleared by FDA for certain anterior and pedicle fixation use indications.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized image of a human figure with three lines extending from the head, resembling a bird in flight. The text is arranged in a circular pattern around the symbol.

FEB 2 1 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, MA 01104

Re: K030241

Trade/Device Name: Blackstone Spinal Fixation System Domino Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal interlaminal fixation orthosi, Spinal intervetebral body fixation Orthosis, Spondylolisthesis spinal fixation device system, Pedicle screw spinal system Regulatory Class: II

Product Code: KWP, KWQ, MNH, MNI Dated: January 22, 2003 Received: January 23, 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 Mav 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" (21 CFR 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,

Miriam C. Provost
for Calia M. Witter, Ph.D., M.D.

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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1030241 Page 1 of 2

# 510(k) Number: K 03024 (

### Device Name: Blackstone™ Spinal Fixation System

#### Indications for Use:

The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:

- a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
- d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

- a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
- b) Fracture:
- c) Dislocation:
- d) Scoliosis;
- e) Kyphosis;
- Spinal tumor; and f)
- g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:

- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- c) spinal stenosis;
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor;
- () pseudoarthrosis;
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation).

The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications:

- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;

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(030241 ige 2 o.

c) spinal stenosis;

d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);

e) tumor;

pseudoarthrosis; f)

g) previous failed fusion; and

h) trauma (i.e., fracture or dislocation).

Concurrence of CDRH, Office of device Evaluation

Prescription Use

OR

Over-The-Counter Use

Miriam C. Provost

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

510(k) Number K630241