PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)

K043206 · Pioneer Surgical Technology · MQP · Jan 21, 2005 · Orthopedic

Device Facts

• Record ID: K043206
• Device Name: PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)
• Applicant: Pioneer Surgical Technology
• Product Code: MQP · Orthopedic
• Decision Date: Jan 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pioneer Vertebral Spacer is intended 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 in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Pioneer Vertebral Spacer 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 system must be used with the Pioneer Quantum Pedicle Screw System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). The interior of the Pioneer Vertebral Spacer implant can be packed with bone.

Device Story

Pioneer Vertebral Spacer is a radiolucent vertebral body replacement implant; used in thoracolumbar spine (T1-L5) following partial vertebrectomy for tumors or fractures; restores biomechanical integrity of spinal column; requires supplemental internal fixation (e.g., Pioneer Quantum Pedicle Screw System); interior cavity packable with bone; implanted by surgeons in clinical settings; provides structural stability to spinal column.

Clinical Evidence

Bench testing only; mechanical and chemical performance data provided.

Technological Characteristics

Radiolucent polymer and titanium alloy materials conforming to ASTM standards; vertebral body replacement form factor; requires supplemental internal fixation; non-powered implant.

Indications for Use

Indicated for skeletally mature patients requiring partial vertebrectomy for tumors or treatment of fractures in the thoracolumbar spine (T1-L5) to achieve anterior decompression and restore vertebral height.

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

• EBI CAS Spine Spacer System (K042268)

Submission Summary (Full Text)

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K043206

JAN ¥ 1 2005

## 510(k) Summary

| SPONSOR: | PIONEER SURGICAL TECHNOLOGY<br>375 River Park Circle<br>Marquette, MI 49855<br>Contact: Jonathan M. Gilbert |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Pioneer Vertebral Spacer |
| CLASSIFICATION: | The classification of the Pioneer Vertebral Spacer is Class II, as per<br>the Code of Federal Regulations, Title 21, Section 888.3060:<br>Implant, fixation, spinal intervertebral body fixation orthosis devices.<br>The product code is MQP. The Panel code is 87. |
| PREDICATE DEVICE: | EBI CAS Spine Spacer System K042268 |
| DEVICE<br>DESCRIPTION: | The Pioneer Vertebral Spacer is a radiolucent vertebral body<br>replacement device of various heights and footprints used in<br>conjunction with supplemental internal fixation to provide structural<br>stability in skeletally mature individuals following corpectomy. |
| INTENDED<br>USE: | The Pioneer Vertebral Spacer is intended for use in the thoracolumbar<br>spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a<br>diseased vertebral body resected or excised for the treatment of<br>tumors in order to achieve anterior decompression of the spinal cord<br>and neural tissues, and to restore the height of a collapsed vertebral<br>body. The Pioneer Vertebral Spacer is also indicated for treating<br>fractures of the thoracic and lumbar spine. The Pioneer Vertebral<br>Spacer is designed to restore the biomechanical integrity of the<br>anterior, middle and posterior spinal column, even in the absence of<br>fusion for a prolonged period of time. The system must be used with<br>the Pioneer Quantum Pedicle Screw System or supplemental internal<br>fixation systems cleared for the conditions listed above (i.e., tumor or<br>trauma of T1-L5). The interior of the Pioneer Vertebral Spacer<br>implant can be packed with bone. |
| MATERIAL: | Radiolucent polymer and titanium alloy materials in conformance<br>with ASTM Standard Specifications. |
| PERFORMANCE: | Mechanical and Chemical information were presented. |
| BASIS OF<br>SUBSTANTIAL<br>EQUIVALENCE: | The Pioneer Vertebral Spacer implants are similar to the components<br>of previously cleared spinal systems in terms of design, indications,<br>performance and materials. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

JAN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jonathan Gilbert Director, Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855

Re: K043206 Trade/Device Name: PIONEER Vertebral Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: November 18, 2004 Received: November 19, 2004

Dear Mr. Gilbert:

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). and occinerefore, 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. Jonathan Gilbert

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hanketing your avenee of your dever to a legally premarket nothication. THC FDA maing of basification 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 specific advice for your do november on a more one the regulation entitled, colliation of Compullios as (21 t notification" (21CFR Part 807.97). You may obtain "Misoranding by relevelec to premance notificalledalisms. In Act from the Division of Small other general information on your responsions at its toll-free number (800) 638-204 or Manufacturers, International and Consalhers http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

L. Mark A. Millman

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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## KOY3206

## Indications for Use

1.

| 510(k) Number (if known): | K043206 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | PIONEER Vertebral Spacer |
| Indications for Use: | The Pioneer Vertebral Spacer is intended 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 in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Pioneer Vertebral Spacer 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 system must be used with the Pioneer Quantum Pedicle Screw System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). The interior of the Pioneer Vertebral Spacer implant can be packed with bone. |
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| | AND/OR |
| | Over-The-Counter Use (21 CFR 807 Subpart C) |

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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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