Synapse Occipital-Cervical-Thoracic (OCT) System

K142838 · Synthes USA Products, LLC · NKG · Jan 20, 2015 · Orthopedic

Device Facts

• Record ID: K142838
• Device Name: Synapse Occipital-Cervical-Thoracic (OCT) System
• Applicant: Synthes USA Products, LLC
• Product Code: NKG · Orthopedic
• Decision Date: Jan 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synapse OCT System, including Synapse, OC Fusion and Axon, is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Synapse OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Axon and Synapse Systems may be connected to the Synthes Universal Spinal System using parallel connectors and tapered rods. The Synapse OCT System can also be linked to the titanium DePuy EXPEDIUM Spine System using the 3.5mm/5.5mm and 4.0mm/5.5mm titanium tapered rods.

Device Story

Synapse OCT System is a posterior spinal fixation construct; includes screws, hooks, rods, plates, transverse bars, and connectors. Used by surgeons in clinical settings to immobilize/stabilize occiput-to-T3 spinal segments. Components link to Synthes Universal Spinal System or DePuy EXPEDIUM Spine System via tapered rods. Provides mechanical support to spinal column; facilitates fusion or maintains integrity in palliative tumor cases. Surgeon selects and implants components to address specific spinal instability; output is a rigid construct providing immediate structural stabilization.

Clinical Evidence

Bench testing only. Testing performed per ASTM F1717 and ASTM F2706, including static compression bending, static torsion, dynamic compression bending, static tensile bending, and dynamic torsion. No clinical data presented.

Technological Characteristics

Construct components (screws, hooks, rods, plates, bars) manufactured from titanium alloys. Utilizes pedicle and lateral mass screws coupled to rigid longitudinal elements. Designed for occiput to T3 fixation. Connectivity via parallel connectors and tapered rods to other spinal systems. Mechanical fixation principle.

Indications for Use

Indicated for patients with acute/chronic instabilities of craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3) requiring immobilization/stabilization as adjunct to fusion. Conditions include traumatic fractures/dislocations, instability/deformity, failed fusions, tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for spinal column integrity restoration in patients with advanced cervical tumors with limited life expectancy where fusion is not achievable.

Regulatory Classification

Identification

Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Special Controls

*Classification.* Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant. (3) Device components must be demonstrated to be biocompatible. (4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (5) Labeling must include the following: (i) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (ii) Intended use and indications for use including levels of fixation; (iii) Device specific warnings, precautions, and contraindications that include the following statements: (A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies ( *e.g.,* CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.” (iv) Identification of magnetic resonance (MR) compatibility status; (v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and; (vi) Detailed instructions of each surgical step, including device removal.

Predicate Devices

• Medtronic Sofamor Danek's AXIS® Fixation System (K062254)

Reference Devices

• CerviFix System
• Axon System
• Synapse System
• OC Fusion System
• Synthes Universal Spinal System
• DePuy EXPEDIUM Spine System

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping faces. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. The logo is black and white.

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

January 20, 2015

Synthes USA Products, LLC % Ms. Kate Larose Manager, Regulatory Affairs DePuy Synthes Spine, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K142838

Trade/Device Name: Synapse Occipital-Cervical-Thoracic (OCT) System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: December 22, 2014 Received: December 24, 2014

Dear Ms. Larose:

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. Kate Larose

forth in the quality systems (OS) 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 yours,

## Vincent J. 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

510(k) Number (if known) K142838

#### Device Name

Synapse Occipital-Cervical-Thoracic (OCT) System

#### Indications for Use (Describe)

The Synapse OCT System, including Synapse, OC Fusion and Axon, is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the instability. The Synapse OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Axon and Synapse Systems may be connected to the Synthes Universal Spinal System using parallel connectors and tapered rods. The Synapse OCT System can also be linked to the titanium DePuy EXPEDIUM Spine System using the 3.5mm/5.5mm titanium tapered rods.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-family: sans-serif;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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| 510(k) Summary – Synapse Occipital-Cervical-Thoracic (OCT) System | |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of 510(k) Sponsor: | Synthes USA Products LLC |
| Name of Presiding Company: | DePuy Synthes Spine, a Johnson & Johnson Company<br>325 Paramount Drive<br>Raynham, MA 02767 |
| 510(k) Contact: | Kate Larose<br>Manager, Regulatory Affairs<br>Telephone: [phone] FAX: [phone]<br>Email: [e-mail] |
| Date Prepared: | January 13, 2015 |
| Trade Name: | Synapse Occipital-Cervical-Thoracic (OCT) System |
| Common Name: | Posterior, Cervical Pedicle Screw Spine Fixation<br>Spinal Interlaminal Fixation Orthosis<br>Posterior Cervical System |
| Classification: | Posterior, Cervical Pedicle Screw Spine Fixation<br>Orthopaedic and Rehabilitation Devices Panel<br>Unclassified; Pre-Amendment Device<br>Product Code: NKG<br><br>Appliance, Fixation, Spinal Interlaminal<br>Orthopaedic and Rehabilitation Devices Panel<br>Class 2 per 21 CFR 888.3050<br>Product Code: KWP |
| Predicate Device: | K062254- Medtronic Sofamor Danek's AXIS® Fixation System |
| Device Description: | The Synapse OCT System, including Synapse, OC Fusion and<br>Axon consists of screws, hooks, rods, plates, transverse bars,<br>parallel connectors, transconnectors, and locking screws. These<br>implants are designed for fixation of the occiput, cervical, and/or<br>upper thoracic spine (Occiput – T3). A complete OCT construct<br>can be created by using components that have been previously<br>cleared within the CerviFix, Axon, Synapse and OC Fusion<br>Systems.<br>The components of the Synapse OCT System are manufactured<br>from Titanium Alloys, similar to the predicate device. |
| Intended Use /<br>Indications for Use: | The Synapse OCT System, including Synapse, OC Fusion and<br>Axon, is intended to provide immobilization and stabilization of<br>spinal segments as an adjunct to fusion for the following acute<br>and chronic instabilities of the craniocervical junction, the<br>cervical spine (C1 to C7) and the thoracic spine (T1-T3):<br>traumatic spinal fractures and/or traumatic dislocations; instability |
| | |
| | tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Synapse OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.<br><br>In order to achieve additional levels of fixation, the Axon and Synapse Systems may be connected to the Synthes Universal Spinal System using parallel connectors and tapered rods. The Synapse OCT System can also be linked to the titanium DePuy EXPEDIUM Spine System using the 3.5mm/5.5mm and 4.0mm/5.5mm titanium tapered rods. |
| Comparison of the technological characteristics of the device to the predicate device: | The Synapse OCT System achieves the same surgical objective as the predicate device. The subject devices and the predicate both utilize pedicle and/or lateral mass screws in the cervical spine coupled to a rigid longitudinal element to achieve immobilization and stabilization of cervical spinal segments as an adjunct to fusion. The key differences in technological characteristics are the cross sectional shape of the rigid longitudinal element, and the means of coupling the rigid longitudinal element to the implanted pedicle and/or lateral mass screws. These technological differences do not raise different questions of safety and effectiveness. |
| Performance Data | Published literature and bench testing per ASTM F1717 and ASTM F2706 (static compression bending, static torsion, dynamic compression bending, static tensile bending and dynamic torsion) demonstrate that the Synapse OCT System is substantially equivalent to the predicate device. |

510(k) Summary – Synapse Occipital-Cervical-Thoracic (OCT) System

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