Streamline OCT Occipito-Cervico-Thoracic System

K150254 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · KWP · Apr 28, 2015 · Orthopedic

Device Facts

• Record ID: K150254
• Device Name: Streamline OCT Occipito-Cervico-Thoracic System
• Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
• Product Code: KWP · Orthopedic
• Decision Date: Apr 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine. The Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.

Device Story

Streamline OCT System is a posterior spinal fixation construct; comprises rods, hooks, polyaxial screws, high-angle screws, locking caps, occipital plates, and connecting components. Used by surgeons in clinical settings to stabilize the occipito-cervico-thoracic spine (occiput-T3) to promote fusion. Components are assembled intraoperatively to create a rigid construct; links to other FDA-cleared pedicle screw systems via connectors. Provides mechanical stabilization following trauma, deformity correction, or degenerative disease treatment. Benefits patient by maintaining spinal alignment and facilitating bone fusion.

Clinical Evidence

Bench testing only. Engineering analysis demonstrated that subject components do not introduce new worst-case performance scenarios. Previous testing of the Streamline OCT system is sufficient to support the performance of the subject components.

Technological Characteristics

Construct components manufactured from ASTM F136 titanium alloy and ASTM F1537 cobalt chromium alloy. Features polyaxial screws with threaded locking mechanisms and pre-bent spinal rods. System is modular, allowing for assembly of occipito-cervico-thoracic constructs and linkage to other pedicle screw systems via connectors.

Indications for Use

Indicated for patients requiring fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) due to degenerative disc disease, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities, tumors, pseudoarthrosis, or revision surgery. Pedicle screws are restricted to T1-T3 thoracic use only; occipital screws are restricted to occipital fixation.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Pioneer Streamline OCT Occipito-Cervico-Thoracic System (K133374)
• DePuy Mountaineer OCT Spinal System (K132332)
• Zimmer Virage OCT Spinal System (K133556)

Reference Devices

• Quantum Spinal Fixation System
• Streamline MIS Spinal Fixation System
• Streamline TL Spinal System

Submission Summary (Full Text)

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

April 28, 2015

Pioneer Surgical Technology, Incorporated (dba RTI Surgical, Incorporated) Ms. Sarah Pleaugh Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855

Re: K150254

Trade/Device Name: Streamline OCT Occipito-Cervico-Thoracic System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: February 2, 2015 Received: February 3, 2015

Dear Ms. Pleaugh:

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 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 Pleaugh

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 Industry and Consumer Education at its toll-free 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Lori A. Wiggins -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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# Indications for Use

510(k) Number (if known)

K150254

#### Device Name

Streamline OCT Occipito-Cervico-Thoracic System

#### Indications for Use (Describe)

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery.

The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine.

The hooks, connectors, and rods are also intended to provide fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

The Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.

| 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) | |

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## 510(k) Summary As required by 21 CFR 807.92 K15___________________________________________________________________________________________________________________________________________________________________________

| Sponsor: | Pioneer Surgical Technology, Inc.<br>(DBA RTI Surgical, Inc.)<br>375 River Park Circle<br>Marquette, MI 49855 USA |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah Pleaugh |
| Phone: | [phone] |
| Fax: | [phone] |
| Prepared: | February 2, 2015 |
| Trade name: | Streamline OCT Occipito-Cervico-Thoracic System |
| Common name: | Posterior Occipito-Cervico-Thoracic System |
| Classification: | Class II per §888.3050 Spinal Interlaminal Fixation Orthosis |
| Product Codes/<br>Panel: | KWP<br>Panel Code 87 |
| Predicates: | K133374 Pioneer Streamline OCT Occipito-Cervico-Thoracic System<br>K132332 DePuy Mountaineer OCT Spinal System<br>K133556 Zimmer Virage OCT Spinal System |
| Description: | The Streamline OCT System consists of a variety of rods, hooks, polyaxial<br>screws, high-angle screws, locking caps, occipital plates, occipital screws,<br>and connecting components used to build an occipito-cervico-thoracic<br>spinal construct. The purpose of this submission is to add components to<br>the predicate K133374 Streamline OCT System. |
| Materials: | The Streamline OCT System components are manufactured from ASTM<br>F136 medical grade titanium alloy and ASTM F1537 medical grade cobalt<br>chromium. Medical grade titanium alloy and medical grade cobalt<br>chromium may be used together. |
| Technological<br>Characteristics: | The subject components are overall similar in technological<br>characteristics as compared to the predicates in terms of:<br>- Basic technology: polyaxial screws with threaded locking mechanism,<br>pre-bent OCT spinal rods<br>- Materials: Titanium alloy and cobalt chromium alloy<br>- Design: sizes and dimensions equivalent or comparable to predicates<br>There are no significant differences between the subject and predicate<br>devices which would raise new issues of safety or effectiveness. |
| | Page 1 of 2 |
| Intended Use: | When intended to promote fusion of the cervical spine and occipito-<br>cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-<br>Cervico-Thoracic System is intended for: degenerative disc disease (as<br>defined by neck or back pain of discogenic origin with degeneration of the<br>disc confirmed by history and radiographic studies), spondylolisthesis,<br>spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability,<br>occipito-cervical dislocation, deformities or curvature, tumors,<br>pseudoarthrosis, and revision of previous cervical and upper thoracic spine<br>surgery.<br><br>The occipital bone screws are limited to occipital fixation only. The use of<br>the pedicle screws (standard and high angle) is limited to placement in the<br>upper thoracic spine (T1-T3) in treating thoracic conditions only. The<br>pedicle screws are not intended for use in the cervical spine.<br><br>The hooks, connectors, and rods are also intended to provide stabilization<br>to promote fusion following reduction of fracture/ dislocation or trauma in<br>the cervical/ upper thoracic (C1-T3) spine.<br><br>The Streamline OCT System can also be linked to FDA cleared pedicle<br>screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS<br>Spinal Fixation System or Streamline TL Spinal System) using connectors. |
| Non-Clinical<br>Performance Data: | Engineering analysis was sufficient to demonstrate that the subject<br>components do not introduce new worst-case components. Previously<br>completed Streamline OCT System testing is sufficient to support the<br>performance of the subject product and therefore, no new testing was<br>required for the determination of substantial equivalence. The subject<br>product is expected to be as safe, as effective, and perform as well as the<br>predicate. |
| Substantial<br>Equivalence: | The subject system is substantially equivalent to previously cleared<br>posterior OCT systems based on comparison of intended use, materials,<br>design, technological characteristics, and performance. |

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