PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM

K073177 · Pioneer Surgical Technology · MAX · May 13, 2008 · Orthopedic

Device Facts

• Record ID: K073177
• Device Name: PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM
• Applicant: Pioneer Surgical Technology
• Product Code: MAX · Orthopedic
• Decision Date: May 13, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pioneer IBF device systems are indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation cleared for the implanted level, such as the Quantum, LowTop or SlimFuse systems. The Cervical IBF device is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined at 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. The Lumbar IBF device system is 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. The lumbar device is to be used in patients who have had six months of non-operative treatment.

Device Story

Radiolucent interbody fusion implant; various heights/footprints to accommodate patient anatomy; used with autogenous bone graft; requires supplemental internal fixation (e.g., Quantum, LowTop, SlimFuse). Implanted by surgeons in clinical settings to provide structural stability in spine. Benefits patients by facilitating fusion in degenerative disc disease cases.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Radiolucent polymer and titanium alloy materials conforming to ASTM standards. Interbody fusion implant design. Standalone device requiring supplemental fixation.

Indications for Use

Indicated for skeletally mature patients requiring intervertebral body fusion. Cervical: one level (C3-T1) for discogenic neck pain with degeneration, failing 6 weeks non-operative treatment. Lumbar: one or two contiguous levels (L2-S1) for degenerative disc disease with up to Grade 1 spondylolisthesis, failing 6 months non-operative treatment.

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 Vertebral Spacer (K061151)
• Medicrea Impix (K072226)
• IST Paramount (K072120)
• Synthes Spacer (K072253)
• BAK Cervical Interbody Fusion device (P980048)

Submission Summary (Full Text)

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## 510(k) Summary

K073177

| Sponsor: | Pioneer Surgical Technology<br>375 River Park Circle<br>Marquette, MI 49855<br>Contact: Jonathan M. Gilbert | MAY 13 2008<br>[phone] |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Device Name: | Pioneer Intervertebral Body Fusion System | |
| Classification: | 888.3080 Intervertebral Fusion Device with bone graft<br>Classification Product Code: MAX<br>Subsequent Product Code: ODP | |
| Predicate Device: | The subject device is substantially equivalent to various cleared devices,<br>including Pioneer's Vertebral Spacer - K061151, Medicrea's Impix<br>K072226, IST's Paramount - K072120, and Synthes Spacer K072253 and<br>P980048/BAK Cervical Interbody Fusion device. | |
| Device Description: | The Pioneer Intervertebral Body Fusion device system is a radiolucent<br>interbody fusion implant comprised of various heights and footprints to<br>accommodate individual patient anatomy and graft material size. It is<br>designed for use with supplemental internal fixation to provide structural<br>stability in skeletally mature individuals. | |
| Intended Use: | The Pioneer IBF device systems are indicated for intervertebral body<br>fusion of the spine in skeletally mature patients. The device systems<br>are designed for use with autogenous bone graft to facilitate fusion.<br>One device may be used per intervertebral space. The implants are<br>intended to be used with supplemental spinal fixation cleared for the<br>implanted level, such as the Quantum, LowTop or SlimFuse systems.<br>The Cervical IBF device is intended for use at one level in the<br>cervical spine, from C3 to T1, for the treatment of cervical disc<br>disease (defined at neck pain of discogenic origin with degeneration<br>of the disc confirmed by history and radiographic studies). The<br>cervical device is to be used in patients who have had six weeks of<br>non-operative treatment.<br>The Lumbar IBF device system is also intended for use at either one<br>level or two contiguous levels in the lumbar spine, from L2 to S1, for<br>the treatment of degenerative disc disease (DDD) with up to Grade 1<br>spondylolisthesis. DDD is defined as back pain of discogenic origin<br>with degeneration of the disc confirmed by history and radiographic<br>studies. The lumbar device is to be used in patients who have had six<br>months of non-operative treatment. | |
| Material: | Radiolucent polymer and titanium alloy materials in conformance with<br>ASTM Standard Specifications. | |
| Basis of Substantial<br>Equivalence: | Documentation was provided which demonstrated the Pioneer Intervertebral<br>Body Fusion system to be substantially equivalent to previously cleared<br>devices. The substantial equivalence is based upon equivalence in intended<br>use, indications, anatomic sites, performance and material of manufacture. | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2008

Pioneer Surgical Technology % Mr. Jonathan M. Gilbert 375 River Park Circle Marquette, MI 49855

Re: K073177

Trade/Device Name: Pioneer Intervertebral Fusion Device System Regulation Number: 21 CFR 888.3080 Regulation Names: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, ODP Dated: April 28, 2008 Received: April 30, 2008

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). 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. Jonathan M. Gilbert

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Miller

Mark N. Melkerson 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 Statement

, '

:

| 510(k) Number (if known): | K073177 | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Device Name: | Pioneer Intervertebral Fusion Device System | |
| Indications for Use: | The Pioneer IBF device systems are indicated for<br>intervertebral body fusion of the spine in skeletally mature<br>patients. The device systems are designed for use with<br>autogenous bone graft to facilitate fusion. One device may<br>be used per intervertebral space. The implants are intended<br>to be used with supplemental spinal fixation cleared for the<br>implanted level, such as the Quantum, LowTop or<br>SlimFuse systems.<br><br>The Cervical IBF device is intended for use at one level in<br>the cervical spine, from C3 to T1, for the treatment of<br>cervical disc disease (defined at neck pain of discogenic<br>origin with degeneration of the disc confirmed by history<br>and radiographic studies). The cervical device is to be used<br>in patients who have had six weeks of non-operative<br>treatment.<br><br>The Lumbar IBF device system is also intended for use at<br>either one level or two contiguous levels in the lumbar<br>spine, from L2 to S1, for the treatment of degenerative disc<br>disease (DDD) with up to Grade 1 spondylolisthesis.<br>DDD is defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and<br>radiographic studies. The lumbar device is to be used in<br>patients who have had six months of non-operative<br>treatment. | |
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>NeilRPO</i> |
|---------------------|----------------|
| (Division Sign-Off) | <i>mkn</i> |

Division of General, Restorative,
and Neurological Devices

| Pioneer Surgical Technology, Inc | Page 37 |
|----------------------------------|---------|
| 510(k) Number | K073177 |