CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC

K133455 · Pioneer Surgical Technology, Inc. · MAX · Mar 27, 2014 · Orthopedic

Device Facts

• Record ID: K133455
• Device Name: CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
• Applicant: Pioneer Surgical Technology, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Mar 27, 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, or Aspect Systems. When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and 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 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, Streamline MIS Systems, or Lat-Fuse Lateral Plate System. When used as a vertebral body replacement (VBR) device (C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and 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 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 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 supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1-L5) such as the Streamline TL Spinal Fixation System. Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.

Device Story

System comprises various footprints/heights of interbody fusion and vertebral body replacement implants; used to restore spinal height and facilitate fusion or biomechanical integrity. Implants inserted via open or minimally invasive approaches (anterior, lateral, posterior, oblique) by surgeons. Radiolucent PEEK Optima construction allows radiographic imaging of fusion status; tantalum or titanium alloy markers provide visibility. Supplemental fixation required for stability. Benefits include decompression of neural tissues and restoration of spinal column integrity. Device is a passive implant; no software or active components.

Clinical Evidence

Bench testing only. Static compression, static torsion (ASTM F2077), static subsidence (ASTM F2267), and static expulsion (Draft Z8423Z) testing demonstrated mechanical strength equivalent to predicates.

Technological Characteristics

Materials: ASTM F2026 PEEK; ASTM F560 tantalum or ASTM F136 titanium alloy markers. Design: Various footprints/heights, including coronal taper and hyperlordotic configurations. Passive implant; no energy source or software.

Indications for Use

Indicated for skeletally mature patients requiring intervertebral body fusion (cervical C2-T1 or lumbar L2-S1) for disc disease/DDD/spondylolisthesis, or thoracolumbar (T1-L5) vertebral body replacement for tumors or fractures. Requires supplemental fixation and 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 (K112496)
• Pioneer IBF/VBR System (K133623)
• Pioneer IBF System (K073177)
• Pioneer VBR System (K043206)
• Pioneer VBR System (K061151)
• NuVasive CoRoent System (K071795)

Submission Summary (Full Text)

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| | 510(k) Summary Pursuant to 21 CFR 807.92 |
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| Sponsor: | Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.)<br>375 River Park Circle<br>Marquette, MI 49855 USA<br>Contact: Emily Downs, Sarah McIntyre<br>Ph: [phone] Fx: [phone]<br>Prepared: March 25, 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 - Class II .<br>21 CFR 888.3060 - Class II |
| Product Codes: | MAX, ODP, MQP |
| Panel/ Branch: | Orthopaedic and Rehabilitation Devices Panel; Panel Code 87 |
| Predicates: | Pioneer IBF/VBR System K112496 &K133623<br>Pioneer IBF System K073177<br>Pioneer VBR System K043206 & K061151<br>NuVasive CoRoent System (K071795) |
| 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 to add implant configurations to the<br>CrossFuse II line of implants, intended for lumbar IBF and VBR use.<br>Class I (exempt) orthopedic manual surgical instruments, including the<br>Clarity Retractor System, are also available for use with the System. |

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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, or Aspect Systems.

> When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and 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 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, Streamline MIS Systems, or Lat-Fuse Lateral Plate System.

> When used as a vertebral body replacement (VBR) device (C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and 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 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 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 supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1-L5) such as the Streamline TL Spinal Fixation System. Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.

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| Pre-Clinical<br>Performance Data: | For a determination of substantial equivalence, static compression and<br>static torsion testing was performed in accordance with ASTM F2077. In<br>addition, static subsidence testing per ASTM F2267 and static expulsion<br>testing per Draft Standard Z8423Z were performed. Mechanical testing<br>showed that the mechanical strength of the subject system is substantially<br>equivalent to a legally marketed predicate and sufficient for the intended<br>use. |
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| | Additional sizes and configurations outside the range of previously cleared<br>devices were justified based on an anatomic rationale. |
| Materials: | The Pioneer IBF/VBR System implants are composed of ASTM F 2026<br>Polyetheretherketone (PEEK) with ASTM F560 tantalum or ASTM F 136<br>Titanium alloy radiographic markers. |
| Summary of<br>Technological<br>Comparison: | The subject implants are unique from the predicate CrossFuse II implants<br>in that they include a coronal taper or increased lordotic angle<br>(hyperlordotic). |
| | This submission supports the position that the subject implants are<br>substantially equivalent to previously cleared IBF/VBR devices. The<br>subject and predicate devices are similar in terms of indications for use,<br>composition, sterilization, packaging,<br>material<br>technological<br>characteristics, design features, and mechanical strength. |
| Substantial<br>Equivalence | There are no significant differences between the subject and predicate<br>devices which would adversely affect the use of the product. Any<br>differences were not considered significant based on mechanical bench<br>testing. |

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G608 Silver Spring, MD 20993-0002

March 27, 2014

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

Re: K133455

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: MAX. ODP. MQP Dated: February 14, 2014 Received: February 18. 2014

#### 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 mislcading.

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. 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 vour 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/McdicalDevices/Resourcesfor You/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/McdicalDevices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Ronald P. Jean -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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

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

#### Indications for Use

510(k) Number (if known) K133455

#### 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 C2-C3 disc to 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 paients who had six weeks of non-operative treatment. IBFs are 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, or 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.

Contraction of the For For For For For For For For For Contract Comments of the Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Formitriev.

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

#### Indications for Use

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

#### 510(k) Number (if known) K133455

#### Device Name

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

#### Indications for Use (Describe)

When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System') is indicated for interverebral body fusion of the spine in skeletally mature patiented for use at either one level or two contiguous levels in the humbar spine, from L2 to S1, for the treatment of decement ve discase (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 radiosraphic studies. Lumbar IIIFFs are to be used in patients who have had six months of non-operative tecament. IBFs are designed for use with autogenous bour graft 10 facilitate fusion. 1895s are intended to be used with supplemental spinal fixation cleared level, such as Quantum. Streamline TL, Contact ALP, Streamline MIS Systems, or Lat-Fuse Lateral Plate System,

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.

FOR FDA USE ONLY

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

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

#### Indications for Use

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

#### 510(k) Number (if known) K133455

#### 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, Contact, CrossFuse, and CrossFuse, and CrossFuse II), the Interbody 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 for the treatment of tumors in order to achieve anterior decompression of the spinal 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 spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with supplemental fixation cleared for the conditions listed above (i.e., tumor of trauma of T1-L5) such as the Streamline TL Spinal Fixation System, Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. 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.

CONTRACTOR COLLEGE FOR FOR EDAUSEIONLY AND THE FOR FOR FOR FOR FOR FOR FOR FOR

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

## Praitriev