BLACKSTONE SPINAL FIXATION SYSTEM SPACER

K022399 · Blackstone Medical, Inc. · KWQ · Aug 6, 2002 · Orthopedic

Device Facts

• Record ID: K022399
• Device Name: BLACKSTONE SPINAL FIXATION SYSTEM SPACER
• Applicant: Blackstone Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 6, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 spondylolisthesis 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 fixation, is intended for the following indications: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spinal stenosis; c) Spondylolisthesis: d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis); e) Pseudarthrosis; f) Tumor; g) Trauma (i.e., fracture or dislocation); h) Previous failed fusion.

Device Story

Titanium alloy (6AL-4V ELI) spacer component for Blackstone Spinal Fixation System; adjunct to spinal implant constructs. Features spherical recess for pedicle screw nesting; enables congruent contact between components. Used by surgeons in clinical settings to stabilize spinal operative sites during bone graft fusion process. Available in two thicknesses; single-use; non-sterile. Provides mechanical immobilization of spinal segments to facilitate fusion.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Titanium alloy (6AL-4V ELI, ASTM F136). Form factor: Spacer with spherical recess for pedicle screw nesting. Available in one diameter, two thicknesses. Non-sterile, single-use. Mechanical fixation device.

Indications for Use

Indicated for skeletally mature patients requiring spinal stabilization/immobilization as an adjunct to fusion for non-cervical spine conditions including degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, degenerative disc disease, and spinal stenosis. Specific pedicle screw use restricted to severe L5-S1 spondylolisthesis (Grades 3-4) with autogenous bone graft and removal after fusion.

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

• Blackstone™ Spinal Fixation System (K994217)
• Blackstone™ Spinal Fixation System Second-Gen Cross-Connector (K003735)
• Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screws (K013558)
• Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screws (K020674)

Submission Summary (Full Text)

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## AUG 0 6 2002

## 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™ Spinal Fixation System<br>Spacer (System Modification) |
| Common Name: | Rod and screw spinal instrumentation |
| Device Product Code<br>& Classification: | MNH 888.3070 - Spondylolisthesis Spinal<br>Fixation 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 Second-Gen Cross-<br>Connector (K003735)<br>Blackstone™ Spinal Fixation System 4.5mm Mono-Axial<br>Screws (K013558) |

## Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screws (K020674)

#### Device Description:

The Blackstone™ Spinal Fixation System Spacer (System Modification) is a titanium alloy (6AL-4V ELI, per ASTM F136) device, which is a non-sterile, single use component. This device is an adjunct to the Spinal Fixation System, which allows a surgeon to build a spinal implant construct. The system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The device added to the current Spinal Fixation System is listed below with a brief description.

#### Spacer:

The Spacer is available in one diameter and two thicknesses. This device may be required in various clinical applications, as determined by a qualified surgeon. The Spacer has a spherical recess feature, which allows the head of a pedicle screw to nest in it for congruent contact between components. For the actual application of the device

KO22390

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refer to the surgical technique in Appendix A, Exhibit D.

The Spacer is available in the configurations are as follows:

Spacer 3mm thickness Spacer 5mm thickness

## Intended Use / Indications for Use:

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 spondylolisthesis 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 fixation, is intended for the following indications:

- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- b) Spinal stenosis;
- c) Spondylolisthesis:
- d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- e) Pseudarthrosis;
- f) Tumor;
- g) Trauma (i.e., fracture or dislocation);
- h) Previous failed fusion.

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# K 022399

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ Spacer is a system modification to the Blackstone™ Spinal Fixation System which has received regulatory clearance as follows:

Blackstone™ Spinal Fixation System (K994217)

Blackstone™ Spinal Fixation System Second-Gen Cross-Connector (K003735) Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screws (K013558) Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screws (K020674)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem. Part of the word "Page" is visible on the right side of the image.

age 1 - Mr. Alan Lombardo

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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AUG 0 6 2002

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

Re: K022399

Trade/Device Name: Blackstone Spinal Fixation System Spacer Regulation Number: 21 CFR 888.3060, 888.3070 Regulation Name: Spinal intervetebral body fixation orthosis; spondylolisthesis spinal fixation device system; pedicle screw spinal system Regulatory Class: Class II Product Code: KWQ, MNH, MNI Dated: July 22, 2002 Received: July 23, 2002

Dear Mr. Lombardo:

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. Iisting 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 mav 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. Alan Lombardo

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 yours.

Sincerely yours,

Mark N. Milburn

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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## Indications for Use:

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 spondylolisthesis 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 fixation, is intended for the following indications:

- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- b) Spinal stenosis;
- c) Spondylolisthesis;
- d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- e) Pseudarthrosis;
- f) Tumor;
- g) Trauma (i.e., fracture or dislocation);
- h) Previous failed fusion.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

f Mark
Sohcurrence of CDRH, Office of Device Evaluation (ODE)
Division Sien om

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

510(k) Number_