PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE

K131724 · Pioneer Surgical Technology, Inc. · MQP · Dec 24, 2013 · Orthopedic

Device Facts

• Record ID: K131724
• Device Name: PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
• Applicant: Pioneer Surgical Technology, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Dec 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MaxFuse VBR System is indicated for use in the thoracolumbar spine (i.e., Ti-1.5) to replace 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 MaxFuse VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The MaxFuse 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. The MaxFuse VBR System is intended for use with supplemental internal fixation systems cleared for the conditions listed above. The supplemental internal fixation systems that may be used include the Quantum Spinal Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS Spinal Fixation System.

Device Story

MaxFuse VBR System is a radiolucent, multilevel corpectomy device used in thoracolumbar spine surgery. It replaces diseased or collapsed vertebral bodies to restore spinal column biomechanical integrity. The system features various footprints, heights, and lordotic angles to accommodate patient anatomy; it may be used with bone graft. It is intended for use with supplemental internal fixation systems (Quantum, Streamline TL, Streamline MIS). The device is implanted by a surgeon during spinal procedures to provide structural support and anterior decompression of neural tissues. It functions as a mechanical spacer to maintain height and stability, potentially benefiting patients by alleviating compression and restoring spinal alignment.

Clinical Evidence

Bench testing only. Performance established through side-by-side mechanical testing per ASTM F 2077 (static/dynamic axial compression, bending, torsion), ASTM F 2267 (static subsidence), and draft Z8423Z (static expulsion).

Technological Characteristics

Constructed from ASTM F 2026 PEEK with ASTM F 560 tantalum or ASTM F 136 titanium alloy radiographic markers. Single-unit VBR design with toothed surface for bone graft containment. Radiolucent material properties.

Indications for Use

Indicated for patients requiring thoracolumbar (T1-L5) vertebral body replacement due to tumor resection/excision or thoracic/lumbar fractures. Used to achieve anterior decompression and restore vertebral height. Requires use with cleared supplemental internal fixation systems.

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

• Pioneer Vertebral Spacer (K061151)
• DePuy Spine Bengal Stackable Cage System (K073649)
• NuVasive Mesh VBR (K032476)

Submission Summary (Full Text)

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K131724

DEC 2 4 2013

## ・ 510(k) SUMMARY
MaxFuse VBR System

| Sponsor: | Manufacturer/<br>(Owner): | Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.)<br>375 River Park Circle<br>Marquette, MI 49855 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | Phone:<br>Fax:<br>Official Contact: | [phone]<br>[phone]<br>Emily M. Downs<br>Sarah McIntyre |
| Device Name: | Date prepared: | December 19, 2013<br>MaxFuse Vertebral Body Replacement (VBR) System |
| Classification<br>Name: | Spinal Vertebral Body Replacement Device | |
| Classification: | 21 CFR 888.3060 - Product code MQP, Class II | |
| Predicate<br>Devices: | Pioneer Vertebral Spacer (K061151)<br>DePuy Spine Bengal Stackable Cage System (K073649)<br>NuVasive Mesh VBR (K032476) | |
| Description: | The MaxFuse VBR System is a radiolucent, multilevel corpectomy system<br>with VBR devices in a variety of footprint options, height options, and<br>lordotic angle options to accommodate a wide variety of patient anatomy.<br>The MaxFuse VBR devices may be used with bone graft. | |
| Intended Use: | The MaxFuse VBR System is indicated for use in the thoracolumbar spine<br>(i.e., Ti-1.5) to replace a diseased vertebral body resected or excised for the.<br>treatment of tumors, to achieve anterior decompression of the spinal cord and<br>neural tissues, and to restore the height of a collapsed vertebral body. The<br>MaxFuse VBR System is also indicated for treating fractures of the thoracic<br>and lumbar spine. The MaxFuse VBR System is designed to restore the<br>biomechanical integrity of the anterior, middle, and posterior spinal column<br>even in the absence of fusion for a prolonged period.<br><br>The MaxFuse VBR System is intended for use with supplemental internal<br>fixation systems cleared for the conditions listed above. The supplemental<br>internal fixation systems that may be used include the Quantum Spinal<br>Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS<br>Spinal Fixation System. | |
| Materials: | The MaxFuse VBR System implants are composed of ASTM F 2026<br>Polyetheretherketone (PEEK) with ASTM F 560 tantalum or ASTM F 136<br>titanium alloy radiographic markers. | |
| Performance Data: | Substantial equivalence was established through side-by-side testing to<br>legally markted predicate devices, including:<br>ASTM F 2077: Static and Dynamic Axial Compression Bending and<br>Static Torsion ASTM F 2267: Static Subsidence Draft Z8423Z, Submitted to ASTM F04.25.02.02: Static Expulsion | |
| Substantial<br>Equivalence: | The subject and predicate systems are overall similar in:<br>Intended Usc Basic design: Single-unit VBR with radiographic markers, toothed surface,<br>bone graft containment Materials: PEEK, Titanium alloy, Tantalum Sizes: Footprints, heights, lordosis comparable to predicates Mechanical Performance: equivalent results There are no significant differences between the subject MaxFuse VBR<br>System and the predicate devices which would adversely affect the use of the<br>product. This submission supports the position that the subject system is<br>substantially equivalent to previously cleared predicate systems. | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 24, 2013

Pioneer Surgical Technology, Incorporated Ms. Sarah McIntyre Regulatory Affairs Associate II 375 River Park Circle Marquette, Michigan 49855

Re: K131724

Trade/Device Name: MaxFuse VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: October 25, 2013 Received: October 29, 2013

Dear Ms. McIntyre:

We have reviewed vour 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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### Page 2 - Ms. Sarah McIntyre

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Lori A. Wiggins

- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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#### Indications for Use Statement

### 510(k) Number (if known): K131724

Device Name: MaxFuse VBR System

Indications:

The MaxFuse VBR System is indicated for use in the thoracolumbar spine (i.e., TI-L5) to replace a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The MaxFuse VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The MaxFuse 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.

The MaxFuse VBR System is intended for use with supplemental internal fixation systems cleared for the conditions listed above. The supplemental fixation systems that may be used include the Quantum Spinal Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS Spinal Fixation System.

Prescription Use V OR (Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedia Devices