STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM

K133374 · Pioneer Surgical Technology, Inc. (Rti Surgical, I · KWP · Mar 19, 2014 · Orthopedic

Device Facts

• Record ID: K133374
• Device Name: STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
• Applicant: Pioneer Surgical Technology, Inc. (Rti Surgical, I
• Product Code: KWP · Orthopedic
• Decision Date: Mar 19, 2014
• 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), spondylolisthesis, 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 stabilization to promote 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

The Streamline OCT System is a posterior spinal fixation construct consisting of rods, hooks, polyaxial/high-angle pedicle screws, locking caps, occipital bone screws, and plates. 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. The system can be linked to other cleared pedicle screw systems via connectors. The device provides mechanical stabilization to the spine, facilitating bone fusion and correcting instability caused by trauma, degeneration, or deformity. It benefits patients by restoring spinal alignment and providing structural support during the healing process.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing only, including ASTM F1717 static and dynamic compression bending and torsion testing, and ASTM F1798 testing of interconnection mechanisms and subassemblies in worst-case spinal constructs.

Technological Characteristics

Construct consists of rods, hooks, polyaxial/high-angle pedicle screws, locking caps, occipital screws, and plates. Materials: ASTM F136 titanium alloy and ASTM F71537 cobalt chromium alloy. Mechanical performance validated per ASTM F1717 and ASTM F1798. System is modular, allowing connection to other cleared pedicle screw systems.

Indications for Use

Indicated for patients requiring spinal fusion in the cervical spine and occipito-cervico-thoracic junction (occiput-T3) due to degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities, tumors, pseudoarthrosis, or revision surgery. Occipital screws limited to occipital fixation; pedicle screws limited to T1-T3 thoracic use only (not for cervical spine).

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 Occipito-Cervico-Thoracic (OCT) System (K121725)
• Exactech Gibralt Occipital Spine System (K110197/K121877)
• Synthes Cervifix/Axon (K991089/K023675)
• Nex-Link Spinal Fixation System (K031985)
• DePuy Mountaineer OCT Spinal System (K110353)
• NuVasive Vuepoint OCT System (K093319)

Reference Devices

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

Submission Summary (Full Text)

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| Sponsor: | Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.)<br>375 River Park Circle<br>Marquette, MI 49855 USA |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Bethany Byman<br>Phone: [phone]<br>Fax: [phone] |
| Prepared: | March 19, 2014 |
| 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: | Pioneer Streamline Occipito-Cervico-Thoracic (OCT) System (K121725)<br>Exactech Gibralt Occipital Spine System (K110197/K121877)<br>Synthes Cervifix/Axon (K991089/K023675)<br>Nex-Link Spinal Fixation System (K031985)<br>DePuy Mountaineer OCT Spinal System (K110353)<br>NuVasive Vuepoint OCT System (K093319) |
| Description: | The Streamline OCT Occipito-Cervico-Thoracic System consists of a variety<br>of rods, hooks, polyaxial pedicle screws, high-angle pedicle screws, locking<br>caps, occipital bone screws, occipital plates and connecting components used<br>to build an occipito-cervico-thoracic spinal construct.<br><br>The purpose of this submission is to add components to the system. |
| Materials: | The system components are manufactured from medical grade ASTM F136<br>titanium alloy and ASTM F71537 cobalt chromium alloy. Medical grade<br>titanium alloy and cobalt chromium alloy may be used together. |
| Pre-Clinical<br>Performance Data: | The subject system was evaluated per ASTM F1717 Static and Dynamic<br>Compression Bending and Torsion Testing and compared to legally marketed<br>predicate systems. Also, ASTM F1798 testing was performed to evaluate the<br>interconnection mechanisms and subassemblies used in the worst-case spinal<br>construct. Testing demonstrated that the device is as safe, as effective and<br>performs as well as or better than predicate systems. |
| Intended Use: | When intended to promote fusion of the cervical spine and occipito-cervico-<br>thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-<br>Thoracic System is intended for: degenerative disc disease (as defined by neck<br>or back pain of discogenic origin with degeneration of the disc confirmed by<br>history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/<br>dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation,<br>deformities or curvature, tumors, pseudoarthrosis, and revision of previous<br>cervical and upper thoracic spine surgery.<br><br>The occipital bone screws are limited to occipital fixation only. The use of the<br>pedicle screws (standard and high angle) is limited to placement in the upper<br>thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws<br>are not intended for use in the cervical spine.<br><br>The hooks, connectors, and rods are also intended to provide stabilization to<br>promote fusion following reduction of fracture/ dislocation or trauma in the<br>cervical/ upper thoracic (C1-T3) spine.<br><br>The Streamline OCT System can also be linked to FDA cleared pedicle screw<br>systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal<br>Fixation System or Streamline TL Spinal System) using connectors. |
| Technological<br>Characteristics: | The subject and predicate systems are overall similar in:<br>- Intended use<br>- Basic design: rod-based with screw/hook/plate anchors and connecting<br>components<br>- Materials: Titanium alloy and cobalt chromium alloy<br>- Sizes: dimensions comparable to predicates<br>- Sterilization and cleaning methods<br>- Performance: equivalent mechanical test results<br><br>The fundamental scientific technology of the subject system is the same as<br>predicate devices. There are no significant differences between the<br>Streamline OCT System and the predicate devices which would adversely<br>affect the use of the product. |
| Substantial<br>Equivalence: | This submission supports the position that the subject system is<br>substantially equivalent to previously cleared pedicle screw systems based<br>on comparison of indications for use, intended use, materials, technological<br>characteristics, and pre-clinical performance testing. |

# 510(k) Summary Pursuant to 21 CFR 807.92

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

March 19, 2014

Pioneer Surgical Technology, Inc. Ms. Bethany Byman Regulatory Affairs Associate II 375 River Park Circle Marquette, Michigan 49855

Re: K133374

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 03, 2013 Received: February 04, 2013

Dear Ms. Byman:

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 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 - Ms. Bethany Byman

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/ResourcesforYou/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 yours,

# Vincen同)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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### Indications for Use Statement

#### 510(k) Number (if known): K133374

Device Name: Streamline OCT Occipito-Cervico-Thoracic System

When intended to promote fusion of the cervical spine and occipito-cervico Indications: thoracic junction (occiput-T3); the Streamline Occipito-Cervico-Thoracic (OCT) 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), spondylolisthesis, 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 stabilization to promote 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.

V OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-the-Counter Use

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

Concurrence of Center for Devices and Radiological Health (CDRH)

# Colin O'Neill

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133374