ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS

K150552 · Globus Medical, Inc. · NKG · Jun 4, 2015 · Orthopedic

Device Facts

• Record ID: K150552
• Device Name: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
• Applicant: Globus Medical, Inc.
• Product Code: NKG · Orthopedic
• Decision Date: Jun 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ELLIPSE® and PROTEX® CT Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-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 facets with instability. These implants 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. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

Device Story

Spinal fixation systems (ELLIPSE and PROTEX CT) provide immobilization/stabilization of craniocervical, cervical, and thoracic spinal segments; components include polyaxial screws, rods, hooks, locking caps, and various connectors; implants surgically placed by surgeons in OR; system provides mechanical support to spinal column; facilitates fusion or restores integrity in palliative tumor cases; output is rigid structural stabilization; benefits include pain reduction and spinal stability.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F1717 (static/dynamic compression bending, static/dynamic torsion) to demonstrate substantial equivalence. No clinical data provided.

Technological Characteristics

Implants composed of titanium alloy (ASTM F136, F1472, F1295), stainless steel (ASTM F138), or cobalt chromium molybdenum alloy (ASTM F1537). System includes polyaxial screws, rods (3.5mm), hooks, and connectors. Mechanical testing per ASTM F1717. No software or energy source.

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, pseudoarthrosis, tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for spinal column integrity restoration in advanced-stage tumor patients 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

• Vertex Reconstruction System (K143471)
• ELLIPSE® OCT Spinal System (K090565, K110963, K123783)
• PROTEX® CT OCT Spinal System (K050391, K081906)
• Synapse OCT System (K142838)

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

Globus Medical, Incorporated Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K150552 Trade/Device Name: ELLIPSE® and PROTEX® CT Occipito-Cervico-Thoracic Spinal Systems Regulatory Class: Unclassified Product Code: NKG, KWP Dated: March 16, 2015 Received: March 17, 2015

June 4, 2015

Dear Dr. Baker:

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 - Kelly J. Baker, Ph.D.

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.

Mark N. Melkerson -S

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)

## K150552

Device Name

ELLIPSE® and PROTEX® CT Occipito-Cervico-Thoracic Spinal Systems

### Indications for Use (Describe)

ELLIPSE® and PROTEX® CT Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-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 facets with instability. These implants 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.

In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary: ELLIPSE® and PROTEX® CT Spinal Systems

| Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>610-930-1800 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D.<br>Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | June 2, 2015 |
| Device Name: | ELLIPSE® and PROTEX® CT<br>Occipito-Cervico-Thoracic Spinal Systems |
| Classification: | Pre-Amendment Device<br>Cervical Pedicle Screw Spinal Fixation Orthosis<br>Product Code: NKG<br>Regulatory Class: Unclassified |
| Classification: | Per 21 CFR as follows:<br>§888.3050 Spinal Interlaminal Fixation Orthosis<br>Product Code: KWP<br>Regulatory Class: II, Panel Code: 87 |

Primary Predicate: Vertex Reconstruction System (K143471)

Additional ELLIPSE® OCT Spinal System (K090565, K110963, K123783) PROTEX® CT OCT Spinal System (K050391, K081906) Predicates: Synapse OCT System (K142838)

## Purpose:

The purpose of this submission is to request additional indications for the use of screws in the posterior cervical spine for the ELLIPSE® and PROTEX® CT Occipito-Cervico-Thoracic Spinal Systems.

### Device Description:

The ELLIPSE® Occipito-Cervico-Thoracic Spinal System consists of 3.5mm jointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, in-line connectors, rod-to-rod connectors, rod extension clamps and occipital plates, CAPITOL™ screws and rods are also available as components of the ELLIPSE® system. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), stainless steel (per ASTM F138) or cobalt chromium molybdenum alloy (CoCr) (per ASTM F1537). Mixing of stainless steel implant components with different

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materials is not recommended for metallurgical, mechanical and functional reasons.

The PROTEX® CT Occipito-Cervico-Thoracic Spinal System consists of rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, and occipital clamps. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295) or stainless steel (per ASTM F138). Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium or titanium alloy implants.

## Indications for Use:

ELLIPSE® and PROTEX® CT Occipito-Cervico-Thoracic Spinal System implants are 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-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. These implants 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.

In order to achieve additional levels of fixation, rods may be connected to other occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

## Performance Data:

There have been no design changes made to the ELLIPSE® and PROTEX® CT Occipito-Cervico-Thoracic Spinal systems in this submission. The purpose of this 510(k) submission is to obtain clearance for the added indications to use posterior screws in the cervical region of the ELLIPSE® (K090565, K110963, K123783) and PROTEX® CT (K050391, K081906) Occipito-Cervico-Thoracic Spinal systems. Published literature and mechanical testing per ASTM F1717 (static/dynamic compression bending, static/dynamic torsion) demonstrate that the ELLIPSE® and PROTEX® CT Occipito-Cervico-Thoracic Spinal systems are substantially equivalent.

## Basis of Substantial Equivalence:

The ELLIPSE® and PROTEX® CT Occipito-Cervico-Thoracic Spinal systems have the same intended use, similar indications for use, similar technological characteristics and design, same materials and the same principles of operation as the predicate device VERTEX Reconstruction System (K143471).