CONSTRUX MINI PEEK VBR SYSTEM

K051246 · Blackstone Medical, Inc. · MQP · Jun 14, 2005 · Orthopedic

Device Facts

• Record ID: K051246
• Device Name: CONSTRUX MINI PEEK VBR SYSTEM
• Applicant: Blackstone Medical, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Jun 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ConstruxTM Mini PEEK VBR System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Construx™M Mini PEEK VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The ConstruxTM Mini PEEK VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The VBR device is intended to be used with bone graft material. The Construx™ Mini PEEK VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the PEEK VBR System is the Blackstone Medical Spinal Fixation System.

Device Story

Spinal vertebral body replacement (VBR) device; fabricated from PEEK Optima LT1; radiolucent material allows post-operative fusion assessment; superior/inferior surface teeth provide stability and prevent migration. Implanted by surgeons in clinical settings to replace diseased or fractured vertebral bodies; restores biomechanical integrity of spinal column; used in conjunction with bone graft and supplemental internal fixation (Blackstone Medical Spinal Fixation System).

Clinical Evidence

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

Technological Characteristics

Constructed from PEEK Optima LT1 per ASTM F-2026; radiolucent; features teeth on superior/inferior surfaces for stability; intended for use with bone graft and supplemental internal fixation.

Indications for Use

Indicated for patients requiring partial vertebrectomy in the thoracolumbar spine (T1-L5) due to tumors, or treatment of thoracic and lumbar spine fractures. Used to achieve anterior decompression and restore vertebral body height. Must be used with bone graft and supplemental internal fixation.

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™ Surgical Titanium Mesh System (K030744)
• Blackstone™ PEEK Vertebral Body Replacement System (K033702)
• Rabea™ Spinal Implant (K043316)
• Spinal Concepts, Inc. FIDJI® Vertebral Body Replacement Types 1, 2, 3 and 4 (K042714)

Submission Summary (Full Text)

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KOS 1246

Premarket Notification 510(k) Blackstone Medical, Inc. Construx™Mini PEEK VBR System

#### 510(K) SUMMARY

## JUN 1 4 2005

| 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: | Construx™ Mini PEEK VBR System |
| Common Name: | Spinal Vertebral Body Replacement Device |
| Device Product Code<br>& Classification: | MQP - 888.3060 - Spinal Intervertebral Body Fixation Orthosis |

#### Substantially Equivalent Devices:

Blackstone™ Surgical Titanium Mesh System (K030744) Blackstone™ PEEK Vertebral Body Replacement System (K033702) Rabea™ Spinal Implant (K043316) Spinal Concepts, Inc. FIDJI® Vertebral Body Replacement Types 1, 2, 3 and 4 (K042714)

#### Device Description:

Blackstone Medical, Inc. Contrux™ Mini PEEK Vertebral Body Replacement (VBR) System is comprised of a variety of implants fabricated and manufactured from Polyetheretherketone (PEEK Optima LT1) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. The teeth on the superior and inferior surfaces of the construct provide increased stability and help prevent anterior/posterior movement of the device.

#### Intended Use / Indications for Use:

The ConstruxTM Mini PEEK VBR System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Construx™M Mini PEEK VBR System is also indicated for treating fractures of the thoracic and lumbar spine.

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Premarket Notification 510(k) Blackstone Medical, Inc. Construx™Mini PEEK VBR System

The ConstruxTM Mini PEEK VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The VBR device is intended to be used with bone graft material

The Construx™ Mini PEEK VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the PEEK VBR System is the Blackstone Medical Spinal Fixation System.

### BASIS OF SUBSTANTIAL EQUIVALENCE:

Construx™ Mini PEEK VBR System is substantially equivalent to the Blackstone™ Surgical Titanium Mesh System (K030744), the Blackstone™ PEEK Vertebral Body Replacement System (K033702), the Rabea™ Spinal Implant (K043316), and the Spinal Concepts, Inc. FIDJI® Vertebral Body Replacement Types 1, 2, 3 and 4 (K042714), which have been cleared by FDA for use in patients with tumor, trauma or fractures.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or bird in flight. The text is arranged in a circular fashion around the image.

JUN 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051246

Trade/Device Name: Construx™ Mini PEEK VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 13, 2005 Received: May 16, 2005

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 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" (21CFR 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.

Sincerely yours,

Hipt Purda

Miriam C. Provost, Ph.D. Acting 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): K051246

Device Name: Construx™ Mini PEEK VBR System

Indications for Use:

The Construx™ Mini PEEK VBR System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Construx™ Mini PEEK VBR System is also indicated for treating fractures of the thoracic and lumbar spine.

The Construx™ Mini PEEK VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The VBR device is intended to be used with bone graft material

The Construx™ Mini PEEK VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the PEEK VBR System is the Blackstone Medical Spinal Fixation System.

Prescription Use × (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)

Division of General, Restorative, and Neurological Devices

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