BLAKSTONE LAMINOPLASTY FIXATION SYSTEM

K043338 · Blackstone Medical, Inc. · NQW · Feb 18, 2005 · Orthopedic

Device Facts

• Record ID: K043338
• Device Name: BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
• Applicant: Blackstone Medical, Inc.
• Product Code: NQW · Orthopedic
• Decision Date: Feb 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Blackstone Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.

Device Story

Blackstone Laminoplasty Fixation System consists of non-sterile, single-use titanium plates and screws; designed for surgical fixation of allograft in lower cervical and upper thoracic spine (C3-T3) post-laminoplasty. Plates feature screw holes at ends for vertebral attachment and a central hole for allograft stabilization. System prevents allograft expulsion and spinal cord impingement. Used by surgeons in clinical/OR settings. Provides mechanical stabilization of bone graft to facilitate healing and protect neural structures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Commercially pure (CP) titanium plates; titanium alloy (6AL-4V ELI, ASTM F-136) screws. Mechanical fixation system; non-sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients undergoing laminoplasty in the lower cervical and upper thoracic spine (C3-T3) to secure allograft placement and prevent spinal cord impingement.

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

• Synthes Arch™ Fixation System (K032534)

Submission Summary (Full Text)

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Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone TM Laminoplasty Fixation System.

FEB 1 8 2005

K043338 age ( of )

## 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™ Laminoplasty Fixation System |
| Common Name: | Interlaminal Fixation Appliance |
| Device Product Code<br>& Classification: | NQW- 888.3050 -Orthosis, Spine, Plate, Laminoplasty, Metal |
| Substantially<br>Equivalent Devices: | Synthes Arch™ Fixation System (K032534) |

### Device Description:

The Blackstone Laminoplasty Fixation System is a device comprised of non-sterile, single use, titanium and titanium allov components. The specially shaped plates, made of commercially pure (CP) titanium, are designed to fit the anatomy of the dorsally elevated lamina. The plates have screw holes on both ends, which allow for attachment to the vertebral body, and a screw hole in the center for attachment to the allograft.

The screws, made of titanium alloy (6AL-4V ELI, per ASTM F-136), are available in variety of lengths and diameters in order to meet individual anatomical requirements.

### Intended Use / Indications for Use:

The Blackstone Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.

### Basis of Substantial Equivalence:

The Blackstone Laminoplasty Fixation System is substantially equivalent to the Synthes Arch™ Fixation System (K032534), which has been cleared by FDA for use as a laminoplasty fixation device.

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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2005

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

Re: K043338

Trade/Device Name: Blackstone ™ Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: NQW Dated: January 28, 2005 Received: February 1, 2005

Dear Mr. Ciporkin:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave a row a ma have determined the device is substantially equivalent (for the indications ferenced above and har sure) to legally marketed predicate devices marketed in interstate for use starsa in the encrease. 976, the enactment date of the Medical Device Amendments. or to conniner of the 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 r ou may, morely mains of the Act include requirements for annual registration, listing of general oblines pro rise first 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 n your device 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 I hat FDA has made a determination that your device complies with other requirements of the Act or any Fedcral 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. 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/industry/support/index.html.

Sincercly yours,

Sincerery yours,

Mark R. Milbers

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

510(k) Number (if known):

Device Name: Blackstone™ Laminoplasty Fixation System

Indications for Use:

The Blackstone Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

338

Mark A Milhous

Peter Live. and Neure

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**510(k) Number**