CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM

K060350 · Blackstone Medical, Inc. · MQP · Feb 24, 2006 · Orthopedic

Device Facts

• Record ID: K060350
• Device Name: CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
• Applicant: Blackstone Medical, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Feb 24, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Construx™ PL/TL PEEK Partial VBR System is indicated for use in the thoracolumbar spine (TI-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™ PL/TL PEEK Partial VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The Construx™ PL/TL PEEK Partial 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 Partial VBR device is intended to be used with bone graft material. The Construx™ PL/TL PEEK Partial VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Construx™ PL/TL PEEK Partial VBR System is the Blackstone Medical Spinal Fixation System.

Device Story

Construx™ PL/TL PEEK Partial VBR System is a spinal implant for partial vertebral body replacement. Fabricated from PEEK Optima LT1 (ASTM F-2026); radiolucent material allows post-operative fusion assessment. Implants feature superior and inferior surface teeth to enhance stability and prevent migration. Used in thoracolumbar spine (T1-L5) to treat tumors or fractures; restores biomechanical integrity of spinal column; facilitates anterior decompression. Requires use with bone graft material and supplemental internal fixation (Blackstone Medical Spinal Fixation System). Operated by surgeons in clinical/OR settings. Benefits patients by restoring vertebral height and spinal stability.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: PEEK Optima LT1 (ASTM F-2026). Radiolucent. Design: Partial vertebral body replacement implant with superior/inferior surface teeth for stability. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with diseased vertebral bodies (tumors) or fractures in the thoracolumbar spine (T1-L5) requiring partial vertebrectomy, anterior decompression, or height restoration of collapsed vertebrae. Intended for use 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™ PEEK Mini Vertebral Body Replacement System (K051246)
• Blackstone™ PEEK Vertebral Body Replacement System (K033702)

Submission Summary (Full Text)

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K060350

Blackstone Medical, Inc.

Premarket Notification Special 51

Construx™ PL/TL PEEK Partial VBR System

FFB 2 4 2006

### 510(K) SUMMARY

| Name of Firm: | Blackstone Medical, Inc.<br>1211 Hamburg Turnpike<br>Wayne, NJ 07470 |
|------------------------------------------|----------------------------------------------------------------------|
| 510(k) Contact: | Whitney Törning, Director of Regulatory Affairs |
| Trade Name: | Construx™ PL/TL PEEK Partial 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™ PEEK Mini Vertebral Body Replacement System (K051246) Blackstone™ PEEK Vertebral Body Replacement System (K033702)

#### Device Description:

Blackstone Medical, Inc. Construx™ PL/TL. PEEK Partial 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 Construx™ PL/TL PEEK Partial VBR System is indicated for use in the thoracolumbar spine (TI-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™ PL/TL PEEK Partial VBR System is also indicated for treating fractures of the thoracic and lumbar spine.

The Construx™ PL/TL PEEK Partial 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 Partial VBR device is intended to be used with bone graft material.

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

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KC6035C

Premarket Notification Special 510(1 Blackstone Medical, Inc. Construx™ PL/TL PEEK Partial VBR System Cattle antial

## Basis of Substantial Equivalence:

The Construx™ PL/TL PEEK Partial VBR System is substantially equivalent to the Blackstone™ Construx™ Mini PEEK VBR System (K051246) and the Blackstone™ PEEK Vertebral Body Replacement System (K033702) which have been cleared by FDA for use in patients with tumor, trauma or fractures.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2006

Ms. Whitney G. Törning Director of Regulatory Affairs Blackstone Medical, Inc. 90 Brookdale Drive Springfield, MA 01104

Re: K060350

: 1800530
Trade/Device Name: Construx™ PL/TL PEEK Partial VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: February 7, 2006 Received: February 10, 2006

Dear Ms. Törning:

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 docs not mean r rease oe avrilour 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 - Ms. Whitney Törning

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risess (evening your device as described in your Section 510(k) This letter will anow you to ogin maing of substantial equivalence of your device to a legally prematication: "The PDF intentigation 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 If you desire spocente advision at [phone]. Also, please note the regulation entitled, Conider the Office of Comptiments market notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your respended its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Helmut Lemus

Mark N. Melkerson, M.S. 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

6060350 510(k) Number (if known): __

Device Name: Construx™ PL/TL PEEK Partial VBR System

## Indications for Use:

The Construx™ PL/TL PEEK Partial VBR System is indicated for use in the The Ounstrax - PETETES for partial replacement of a diseased vertebral body thoracolumbur opino ( the treatment of tumors, to achieve anterior decompression resected of excised for the troutinent spare the height of a collapsed or the Spinal Cord and Hourar (ISSue), and the Partial VBR System is also indicated for treating fractures of the thoracic and lumbar spine.

The Construx™ PL/TL PEEK Partial VBR System is designed to restore the The Construx - - | Ercof the anterior, middle and posterior spinal column even in blomeonaniour freship for a prolonged period of time. The Partial VBR device is intended to be used with bone graft material.

The Construx™ PL/TL PEEK Partial VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may supplemental internal included "the PEEK Partial VBR System is the Blackstone Medical Spinal Fixation System.

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 CDRM, Office of Device Evaluation (ODE)

Haki Leung

Page 1 of

(Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________