C-PLUS

K133623 · Pioneer Surgical Technology, Inc. · ODP · Feb 10, 2014 · Orthopedic

Device Facts

• Record ID: K133623
• Device Name: C-PLUS
• Applicant: Pioneer Surgical Technology, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Feb 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, 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. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Streamline OCT, SlimFuse, Cequence, PAC, Aspect Systems. When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from the 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. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, or Streamline MIS Systems. When used as a vertebral body replacement (VBR) device (C-Plus, Rotate. Bullet-Tip, T-Plus, Contact, CrossFuse, CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") 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 turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. 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 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 VBR device is intended to be used with bone graft.

Device Story

The IBF/VBR System consists of spinal implants with various footprints and heights, designed for intervertebral body fusion or vertebral body replacement. Implants are inserted by surgeons via open or minimally invasive approaches (anterior, lateral, posterior, oblique) to address spinal pathology. The device acts as a structural spacer to restore disc height or replace resected vertebral bodies, facilitating fusion when used with autogenous bone graft and supplemental fixation. Implants are radiolucent (PEEK) with radiopaque markers (tantalum or titanium) to allow radiographic assessment of fusion status. The system provides biomechanical stability to the spinal column. Benefits include decompression of neural tissues, restoration of vertebral height, and stabilization of the spine in patients with degenerative disc disease, tumors, or fractures.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance was validated through static compression and torsion testing (ASTM F2077), static subsidence testing (ASTM F2267), and static expulsion testing (Draft Standard Z8423Z).

Technological Characteristics

Implants manufactured from ASTM F2026 PEEK-Optima. Radiographic markers composed of ASTM F560 tantalum or ASTM F136 titanium alloy. Device is a structural interbody spacer/vertebral body replacement. Sterilization method not specified. No software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring intervertebral body fusion or vertebral body replacement. Cervical IBF: one level (C2-T1) for discogenic neck pain after 6 weeks non-operative treatment. Lumbar IBF: one or two levels (L2-S1) for degenerative disc disease with up to Grade 1 spondylolisthesis after 6 months non-operative treatment. VBR: thoracolumbar (T1-L5) for partial vertebrectomy due to tumors or fractures to restore height and biomechanical integrity. Requires autogenous bone graft and supplemental spinal fixation.

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 (K112496)
• Pioneer IBF System (K073177)
• Pioneer VBR System (K043206)
• Pioneer VBR System (K061151)

Submission Summary (Full Text)

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# 510(k) Summary Pursuant to 21 CFR 807.92

| 510(k) Summary Pursuant to 21 CFR 807.92 | FEB 10 2014 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Pioneer Surgical Technology, Inc.<br>(RTI Surgical, Inc.)<br>375 River Park Circle<br>Marquette, MI 49855 USA<br>Contact: Emily M. Downs, Sarah McIntyre<br>Ph: [phone]<br>Fx: [phone]<br>Prepared: February 6, 2014 |
| Name: | Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System |
| Trade names: | C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, CrossFuse II |
| Common name: | Intervertebral Body Fusion Device/ Vertebral Body Replacement Device |
| Classifications: | 21 CFR 888.3080 and 888.3060, Class II |
| Product Codes: | ODP, MAX, MQP |
| Panel: | Orthopaedic and Rehabilitation Devices Panel; Panel Code 87 |
| Predicates: | Pioneer IBF/VBR System K112496<br>Pioneer IBF System K073177<br>Pioneer VBR System K043206 & K061151 |
| Description: | The Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System<br>consists of a variety of different footprints and heights which enable the<br>surgeon to choose the implant best suited to an individual's pathology and<br>anatomical condition. Supplemental anterior and/or posterior fixation is<br>intended for use with the device to ensure stability of the spine and<br>adequate compression of the implant. The IBF/VBR implants may be<br>implanted via a variety or open or minimally invasive approaches,<br>including anterior, lateral, posterior and oblique.<br>The components are manufactured from a radiolucent polymer (PEEK<br>Optima®) in order to allow radiographic imaging inside the implant to<br>evaluate fusion status.<br>The purpose of this submission is a line extension to add an additional<br>design to the currently available C-Plus implants. The subject implants<br>are for Cervical Intervertebral Body Fusion only.<br>Class I (exempt) orthopedic manual surgical instruments are also available |

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Intended Use: When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, 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. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Streamline OCT, SlimFuse, Cequence, PAC, Aspect Systems.

> When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from the 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. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, or Streamline MIS Systems.

> When used as a vertebral body replacement (VBR) device (C-Plus, Rotate. Bullet-Tip, T-Plus, Contact, CrossFuse, CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") 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 turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. 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 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 VBR device is intended to be used with bone graft.

> > Page 2 of 3

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Pre-Clinical For a determination of substantial equivalence, static compression and Performance Data: static torsion testing was performed in accordance with ASTM F2077. In addition, static subsidence testing per ASTM F2267 and static expulsion testing per Draft Standard Z8423Z were performed. Mechanical testing showed that the mechanical strength of the subject system is substantially equivalent to a legally marketed predicate and sufficient for the intended use.

- Materials: The Pioneer IBF/VBR System implants are composed of ASTM F 2026 Polyetheretherketone (PEEK) with ASTM F560 tantalum or ASTM F 136 Titanium alloy radiographic markers.
- Pre-Clinical For a determination of substantial equivalence, static compression and Performance Data: static torsion testing was performed in accordance with ASTM F2077. In addition, static subsidence testing per ASTM F2267 and static expulsion testing per Draft Standard Z8423Z were performed. Mechanical testing showed that the mechanical strength of the subject system is substantially equivalent to a legally marketed predicate and sufficient for the intended use.
- Summary of The subject implants are unique from the C-Plus implants included in the Technological predicate system in that they consist of a 10X12mm footprint with no strut Comparison: across the midline.

This submission supports the position that the subject implants are substantially equivalent to previously cleared interbody fusion devices. The subject and predicate devices are similar in terms of indications for use, material composition, sterilization, packaging, technological characteristics, design features, and mechanical strength.

- Substantial There are no significant differences between the subject and predicate Equivalence devices which would adversely affect the use of the product. Any differences were not considered significant based on mechanical bench testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes. 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

February 10, 2014

Pioneer Surgical Technology, Incorporated (RTI Surgical, Inc.) Ms. Emily Downs Director of Clinical and Regulatory Affairs 375 River Park Circle Marquette, Michigan 49855

Re: K133623

Trade/Device Name: Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX, MOP Dated: November 22, 2013 Received: November 26, 2013

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 vour 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. Emily Downs

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/Resourcesfor You/Industry/default.htm. 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.

# Vincent訂)Devlin -S

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K133623

#### Device Name

Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System

#### Indications for Use (Describe)

When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C7-T1 disc, 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 had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone acvise is to facilitate fision. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Streamline OCT, SlimFuse, Cequence, PAC, Aspect Systems.

Type of Use (Select one or both, as applicable)

🇿 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

11 44 1 3 4 3 4 3 4 1 2 1 1 1 5 FORIEDA USE ONLY 3 1 1 1 1 1 1 1 1 1 1 1 1 1 2 6 2 6 1

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K133623

#### Device Name

Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System

#### Indications for Use (Describe)

When used as a lumbar interverebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for interverebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine. from the L2 to S1, 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. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, or Streamline MIS Systems.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Divis

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K133623

#### Device Name

Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System

#### Indications for Use (Describe)

When used as a vertebral body replacement (VBR) device (C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse II), the Interhody Fusion (IBF) / Vertebral Body Replacement (VBR) System'') is intended for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebral body resected or excised 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. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are 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 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 VBR device is intended to be used with bone graft.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR A

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/7/Picture/13 description: The image shows the text "Anton E. Dmitriev, PhD" at the top, with a line underneath. Below that is a logo, and then the text "Division of Orthopedic Devices". The text is black and the background is white.

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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