BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER

K022605 · Blackstone Medical, Inc. · KWQ · Aug 21, 2002 · Orthopedic

Device Facts

• Record ID: K022605
• Device Name: BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
• Applicant: Blackstone Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 21, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for anterolateral screw/staple fixation of the T6-L5 spine, is intended for the following indications: a) Degenerative disc disease (ddd) -- this should be defined. Based on the 5/23/96 Panel meeting, ddd should be defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. b) Spondylolisthesis c) Trauma (i.e., fracture or dislocation) d) Spinal stenosis; e) Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) f) Tumor g) Pseudarthrosis h) Previous failed fusion.

Device Story

Titanium alloy (6AL-4V ELI) staple and washer components; adjunct to Blackstone Spinal Fixation System. Staple features conical recess for pedicle screw nesting and three-pronged trocar tip for vertebral body fixation. Washer features conical recess for screw nesting. Used by surgeons in clinical settings to stabilize spinal operative sites during bone graft fusion process. Components allow surgeon to build spinal implant construct; provide congruent contact between pedicle screw head and vertebral body. Benefits include enhanced fixation and stabilization of spinal segments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium alloy (6AL-4V ELI, ASTM F136). Components: Staple (three-pronged, trocar tip, conical recess) and Washer (conical recess). Dimensions: Available in 2mm, 4mm, and 6mm thicknesses. Non-sterile, single-use. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring non-cervical spinal fixation (T6-L5) for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or previous failed 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 Screw (K020674)

Submission Summary (Full Text)

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## AUG 2 1 2002

page 1 of 3

# KOZZ605

## 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>Staple & Washer (System Addition) |
| Common Name: | Rod and screw spinal instrumentation |
| Device Product Code & Classification: | KWQ 888.3060 - Spinal Intervertebral Body Fixation<br>Orthosis |
| Substantially Equivalent Devices: | Blackstone™ Spinal Fixation System (K994217)<br>Blackstone™ Spinal Fixation System Second-Gen Cross Connector (K003735)<br>Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screws (K013558)<br>Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screw (K020674) |

#### Device Description:

The Blackstone™ Spinal Fixation System Staple & Washer (System Modification) are titanium alloy (6AL-4V ELI, per ASTM F136) devices, which are non-sterile, single use components. These devices are 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 devices added to the current Spinal Fixation System are listed below with a brief description.

#### Staple:

The Staple is available in one diameter and three thicknesses. This device may be required in various clinical applications, as determined by a qualified surgeon. The Staple has a conical recess feature, which allows the head of a pedicle screw to nest in it for congruent contact between components. Furthermore, the device has three prongs with a trocar tip which fix's the device to a vertebral body. For the

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K022605

actual application of the device refer to the surgical technique in Appendix C, Exhibit I.

The Staple is available in the configurations are as follows:

Spacer 2mm thickness Spacer 4mm thickness Spacer 6mm thickness

#### Washer:

The Washer is available in one diameter and three thicknesses. This device may be required in various clinical applications, as determined by a qualified surgeon. The Washer has a conical 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 refer to the surgical technique in Appendix C, Exhibit I.

The Washer is available in the configurations are as follows:

Spacer 2mm thickness Spacer 4mm thickness Spacer 6mm 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 anterolateral screw/staple fixation of the T6-L5 spine, is intended for the following indications:

- a) Degenerative disc disease (ddd) this should be defined. Based on the 5/23/96 Panel meeting, ddd should be defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- b) Spondylolisthesis
- c) Trauma (i.e., fracture or dislocation)
- d) Spinal stenosis;
- e) Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- f) Tumor
- g) Pseudarthrosis
- h) Previous failed fusion.

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K022605

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## BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ Staple & Washer 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)

510(k) Number:

Device Name: Blackstone™ Spinal Fixation System

Summary

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol with three lines forming its head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2002

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

Re: K022605

Trade/Device Name: Blackstone™ Spinal Fixation System Staple and Washer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: K WQ Dated: August 2, 2002 Received: August 6, 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, 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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Paqe 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.

R. Mark N. Millersen

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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K022605 page 1 of 1

#### Indications for Use:

Blackstone Spinal Fixation System is intended for non-cervical use in the spine.

The Blackstone Spinal Fixation System, when used for anterolateral screw/staple fixation of the T6-L5 spine, is intended for the following indications:

a) Degenerative disc disease (ddd) -- this should be defined. Based on the 5/23/96 Panel meeting, ddd should be defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

b) Spondylolisthesis

c) Trauma (i.e., fracture or dislocation)

d) Spinal stenosis;

- e) Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
f) Tumor

g) Pseudarthrosis

h) Previous failed fusion.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR801.109

Mark A. Mellecker

Division of General. Restorative and Neurological Devices

510(k) Number

KO 2266