PIONEER CROSSFUSE II IBF/VBR SYSTEM

K112496 · Pioneer Surgical Technology, Inc. · MAX · Sep 28, 2011 · Orthopedic

Device Facts

• Record ID: K112496
• Device Name: PIONEER CROSSFUSE II IBF/VBR SYSTEM
• Applicant: Pioneer Surgical Technology, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Sep 28, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pioneer IBF/VBR System, when used as an IBF implant, is indicated for intervertebral body fusion of the spine in skeletally mature patients. Pioneer IBFs are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. Pioneer IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as the Quantum, Streamline, Contact ALP or SlimFuse systems. The Cervical IBF device in intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. Lumbar IBFs are also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. The Pioneer IBF/VBR System, when used as a VBR implant, 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. Pioneer VBRs are also indicated for treating fractures of the thoracic and lumbar spine. Pioneer VBRs are 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 Spinal Fixation System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). Additionally, the Pioneer Vertebral Spacer implant is intended to be used with bone graft.

Device Story

Pioneer IBF/VBR System consists of spinal implants (interbody fusion/vertebral body replacement) used by surgeons in clinical settings; implants restore vertebral height and provide biomechanical stability; used for cervical/lumbar disc disease, tumors, or fractures; requires supplemental internal fixation and autogenous bone graft; implants available in various shapes/sizes to match patient anatomy; device provides structural support to spinal column; facilitates fusion or maintains integrity post-resection.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing only, including static compression, static torsion, subsidence, and expulsion testing.

Technological Characteristics

Implants manufactured from PEEK with tantalum or titanium alloy markers. System includes various shapes and sizes. Mechanical performance validated via static compression, static torsion, subsidence, and expulsion testing.

Indications for Use

Indicated for skeletally mature patients requiring intervertebral body fusion (cervical C3-T1 for disc disease; lumbar L2-S1 for DDD with Grade 1 spondylolisthesis) or vertebral body replacement (thoracolumbar T1-L5 for tumors or fractures). Requires supplemental fixation and autogenous bone graft.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Pioneer IBF/VBR System (K043206)
• Pioneer IBF/VBR System (K061151)
• Pioneer IBF/VBR System (K073177)

Reference Devices

• Quantum Spinal Fixation System
• Streamline system
• Contact ALP system
• SlimFuse system

Submission Summary (Full Text)

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## 510(k) SUMMARY

# Pioneer IBF/VBR System

SEP 2 8 2011

| Sponsor: | Manufacturer | Pioneer Surgical Technology<br>375 River Park Circle<br>Marquette, MI 49855 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| | Official Contact<br>Phone:<br>Fax: | Emily M. Downs<br>[phone]<br>[phone] |
| | Date prepared: | September 28, 2011 |
| Device Name: | Pioneer Interbody Fusion/Vertebral Body Replacement System | |
| Classification<br>Name: | Intervertebral Body Fusion Device / Vertebral Spacer Device | |
| Classification<br>Number: | 21 CFR 888.3080 - product codes MAX and ODP, class II | |
| | 21 CFR 888.3060 - product code MQP, class II | |
| Description: | The Pioneer IBF/VBR System is an implantable device manufactured from<br>PEEK and tantalum or titanium alloy that is available in a variety of different<br>shapes and sizes to suit the individual pathology and anatomical conditions<br>of the patient. | |
| | The purpose of the submission was to add the CrossFuse II device to the<br>system. | |
| Intended Use: | The Pioneer IBF/VBR System, when used as an IBF implant, is indicated for<br>intervertebral body fusion of the spine in skeletally mature patients. Pioneer<br>IBFs are designed for use with autogenous bone graft to facilitate fusion.<br>One device may be used per intervertebral space. Pioneer IBFs are intended<br>to be used with supplemental spinal fixation cleared for the implanted level,<br>such as the Quantum, Streamline, Contact ALP or SlimFuse systems. | |
| | The Cervical IBF device in intended for use at one level in the cervical spine,<br>from C3 to T1, for the treatment of cervical disc disease (defined as neck pain<br>of discogenic origin with degeneration of the disc confirmed by history and<br>radiographic studies). The cervical device is to be used in patients who have<br>had six weeks of non-operative treatment. | |

Lumbar 1BFs are also intended for use at either one level or two contiguous

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levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment.

The Pioneer IBF/VBR System, when used as a VBR implant, 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. Pioneer VBRs are also indicated for treating fractures of the thoracic and lumbar spine. Pioneer VBRs are 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 Spinal Fixation System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). Additionally, the Pioneer Vertebral Spacer implant is intended to be used with bone graft.

- The Pioneer IBF/VBR System are composed of Polyether ether ketone (PEEK) Material: with tantalum or titanium alloy markers. The predicate device is composed of the same materials.
The indication for use and material composition of the Pioneer IBF/VBR Comparison to Predicate System are the same as the currently cleared predicate device, Pioneer Devices IBF/VBR System (K043206/K061151/K073177). The differences in dimensional specifications between the subject devices and the predicate were not considered significant based on mechanical testing.

For a determination of substantial equivalence, the following non-clinical Performance mechanical tests were performed: Data:

- Static Compression �
- Static Torsion ●
- Subsidence .
- Expulsion ●

Based on the supporting documentation within this premarket notification, Performance the subject device demonstrates substantial equivalence to the listed and SE predicate devices. Determination:

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

SEP 2 8 2011

Pioneer Surgical Technology % Ms. Emily M. Downs 375 River Park Circle Marquette, Michigan 49855

Re: K112496

Trade/Device Name: Pioneer Interbody Fusion / Vertebral Body Replacement System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX. ODP. MOP Dated: August 24, 2011 Received: August 29, 2011

Dear Ms. Downs:

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. 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

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Page 2 - Ms. Emily M. Downs

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutfDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours.

Euna M. Keith

So Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative 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): K112496

Device Name:

### Pioneer Interbody Fusion /Vertebral Body Replacement System

Indications:

The Pioneer IBF/VBR System, when used as an IBF implant, is indicated for intervertebral body fusion of the spine in skeletally mature patients. Pioner 1BFs are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. Pioneer IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as the Quantum, Streamline, Contact ALP or SlimFuse systems.

The Cervical IBF device in intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment

Lumbar IBFs are also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to St, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment.

The Pioneer IBF/VBR System, when used as a VBR implant, is intended for use in the thoracolumbar spine (T1-L.S) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. Pioneer VBRs are also indicated for treating fractures of the thoracic and lumbar spine. Pioneer VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a proloneed period of time. The system must be used with the Pioneer® Quantum Spinal Fixation System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of TI-L5). Additionally, the Pioneer Vertebral Spacer implant is intended to be used with bone graft.

> イ Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KI12496 510(k) Number_

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