MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM

K023498 · Blackstone Medical, Inc. · KWP · Nov 13, 2002 · Orthopedic

Device Facts

• Record ID: K023498
• Device Name: MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
• Applicant: Blackstone Medical, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Nov 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

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 (1.3 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; f) Spinal tumor; and 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; f) 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; c) spinal stenosis; d) spinal deformities (i.e., scoliosis, kyphosis, lordosis); e) tumor; f) pseudoarthrosis; g) previous failed fusion; and h) trauma (i.e., fracture or dislocation).

Device Story

Titanium alloy (6AL-4V ELI) spinal fixation system consisting of multi-axial screws and rods; used to build spinal implant constructs for non-cervical spine stabilization. Surgeon-operated in clinical/OR settings; screws attached to vertebral body to provide immobilization as adjunct to fusion. Output is mechanical stabilization of spinal segments; aids in treating instabilities/deformities. Benefits include structural support during bone graft fusion process.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use similarities to predicate devices.

Technological Characteristics

Titanium alloy (6AL-4V ELI, ASTM F136); multi-axial screw and rod configuration; non-sterile, single-use; mechanical fixation; non-cervical application.

Indications for Use

Indicated for non-cervical spinal stabilization/immobilization as an adjunct to fusion in skeletally mature patients. Conditions: severe spondylolisthesis (L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, degenerative disc disease, and spinal stenosis.

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)

Reference Devices

• DePuy Motech Moss Miami Spinal System (K980477, K982320)

Submission Summary (Full Text)

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KO23498

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| 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™ Spinal Fixation System<br>Spinal Fixation System<br>Multi-Axial Screws |
| 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 |
| Substantially<br>Equivalent Devices: | Blackstone™ Spinal Fixation System (K994217)<br>Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screws<br>(K020674) |

### Device Description:

The Blackstone™ Spinal Fixation System 4.5mm, 5.5mm, and 7.5mm Multi-Axial Screws are titanium alloy (6AL-4V ELI, per ASTM F136) devices, which are non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the noncervical spine.

The Blackstone Spinal Fixation System consists of an assortment of screws and rods which have received 510(k) clearance (#K994217, and #K020674).

## 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;

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# KOZ3498

- 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 (1.3 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;
- f) Spinal tumor; and
- 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;
- spinal stenosis; c)
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor;
- pseudoarthrosis; t)
- 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;
- এ pseudoarthrosis;
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation).

### BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ 4.5mm, 5.5mm, 6.5mm, and 7.5mm Multi-Axial Screws by their very nature are substantially equivalent to the DePuy Motech Moss Miami Spinal

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K023498

System (K980477, K982320) which has been cleared by FDA for certain anterior and pedicle fixation use indications.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

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

# Re: K023498

Trade/Device Name: Blackstone Spinal Fixation System Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070

Regulation Name: Spinal interlaminal fixation orthosis; Spinal intervetebral body fixation orthosis; Spondylolisthesis spinal fixation device system; Pedicle screw spinal system

Regulatory Class: Class II Product Code: KWP, KWQ, MNH, MNI Dated: October 14, 2002 Received: October 18, 2002

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

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Page 2 -- Mr. Dean E. Ciporkin

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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, 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). Other general information on your responsibilities under the Act may be obtained 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 Milliman

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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# 510(k) Number: K023498

### Device Name: Blackstone™ Spinal Fixation S

### 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 (1.3 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 instabilitics 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 C
- 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);
- spondylolistheses; b)
- spinal stenosis: c)
- spinal deformities (i.e., scoliosis, kyphosis, lordosis); d)
- tumor; e)
- pseudoarthrosis: ()
- previous failed fusion; and g)
- 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) Degencrative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;

Mark A. Millican

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Neurological

510(k) Numbe

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

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e) tumor;

- pseudoarthrosis; f)
- previous failed fusion; and g)
- h) trauma (i.e., fracture or dislocation).

Concurrence of CDRH, Office of device Evaluation

OR

Mark N Melkerin
(Division Sign-Off)

Division of Gener iestorative and Neurological L ් පිළිප

510(k) Number K023498

Prescription Use Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________