REVERE STABILIZATION SYSTEM

K133350 · Globus Medical, Inc. · NKB · Mar 11, 2014 · Orthopedic

Device Facts

• Record ID: K133350
• Device Name: REVERE STABILIZATION SYSTEM
• Applicant: Globus Medical, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Mar 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The REVERE® Stabilization System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, pseudoarthrosis and failed previous fusion. In addition, the REVERE® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium. When used as a posterior non-pedicle screw fixation system, the REVERE® Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, and/or lordosis, Scheuermann's disease), fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium. When used as an anterolateral thoracolumbar system, the REVERE® Stabilization System is intended for anterolateral screw (with or without staples or staple plates) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

Device Story

REVERE® Stabilization System is a spinal fixation construct consisting of rods, hooks, monoaxial/polyaxial/uniplanar/reduction screws, locking caps, t-connectors, and various plates/staples. System provides rigid immobilization of thoracic, lumbar, and sacral spinal segments. Surgeons implant components posteriorly or anterolaterally to stabilize the spine during fusion procedures. Screws are inserted into pedicles or vertebral bodies; rods are secured to screws/hooks via locking caps with inner set screws. T-connectors provide cross-member structural support. System accommodates 5.5mm or 6.35mm diameter rods. Device is used in clinical/surgical settings by orthopedic or neurosurgeons. Output is a stabilized spinal construct that facilitates bone fusion and corrects deformities. Benefits include structural support for unstable spinal segments and correction of spinal pathologies.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing only, specifically static and dynamic compression, static torsion, and static screw head pull-off testing conducted in accordance with ASTM F1717 and FDA guidance for spinal systems.

Technological Characteristics

Constructs utilize titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel (ASTM F136, F1295, F1472, F67, F1537, F138). Screws may feature hydroxyapatite (HA) coating (ASTM F1185). System is modular, utilizing rods (5.5mm or 6.35mm diameter), screws, hooks, and connectors. Mechanical performance validated per ASTM F1717. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Treats degenerative disc disease, spondylolisthesis, spinal stenosis, scoliosis, kyphosis, lordosis, Scheuermann's disease, fracture, dislocation, tumor, pseudoarthrosis, and failed fusion. Specific indications for severe spondylolisthesis (Grades 3-4) at L5-S1. Contraindications include galvanic corrosion risk if stainless steel is connected to titanium/cobalt-chrome alloys.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• REVERE® Stabilization System (K061202, K122226)

Reference Devices

• Stryker XIA® Spine System (K984251, K113666)
• Medtronic CD HORIZON® (K961633, K130646)
• Synthes Posterior Universal Spine System (K982987)
• PROTEX® system
• BEACON® Stabilization System
• TRANSITION® Stabilization System

Submission Summary (Full Text)

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# 510(k) Summary: REVERE® Additional Implants

# MAR 1 1 2014

| Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>610-930-1800 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Christina Kichula<br>Group Manager, Regulatory Affairs |
| Date Prepared: | October 2, 2013 |
| Device Name: | REVERE® Stabilization System |
| Classification: | Per 21 CFR as follows:<br>§888.3050 Spinal Interlaminal Fixation Orthosis<br>§888.3060 Spinal Intervertebral Body Fixation<br>Orthosis<br>§888.3070 Pedicle Screw Spinal System<br>§888.3070 Spondylolisthesis Spinal Fixation Device<br>System<br>Product Codes MNH, MNI, NKB, KWP, KWQ<br>Regulatory Class III, Panel Code 87. |
| Predicate(s): | REVERE® Stabilization System (K061202, K122226) |

- 226) Stryker XIA® Spine System (K984251, K113666) Medtronic CD HORIZON® (K961633, K130646) Synthes Posterior Universal Spine System (K982987)
## Purpose:

The purpose of this submission is to request clearance for additional threaded screws with a threaded locking cap and closed head screws in the REVERE® Stabilization System.

## Device Description:

The REVERE® Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking caps, tconnectors, offset housing clamps, head offset connectors, trans-illiac connectors, sacral and sacral-iliac plates, staples and staple plates, and associated manual surgical instruments. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. REVERE® implants mate with 5.5mm diameter rods; REVERE® 6.35 implants mate with 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples and staple plates are intended for anterior use only. Rods and monoaxial

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screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod, trans-iliac connectors and sacral-iliac plates.

The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.

The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.

Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae, pedicles, or transverse process of the posterior spine.

T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the t-connectors to the rods. Additional set screws secure the adjustable cross members at the desired length. T-connectors from the PROTEX® system may be used with 6.5mm, 6.0mm or 5.5mm rod systems. REVERE® t-connectors may only be used with 5.5mm rods; REVERE® 6.35 tconnectors may only be used with 6.35mm rods. Additional connectors may be used to connect two rods, and are also secured using set screws.

REVERE® hooks and t-connectors, and 5.5mm or 6.35mm diameter rods may be used with the BEACON® Stabilization System.

REVERE® screws and locking caps may be used with the TRANSITION® Stabilization System. Specifically, REVERE® polyaxial (solid, cannulated and dual outer diameter) screws and monoaxial screws 6.5mm diameter and larger, and 35mm length and longer, may be used with the TRANSITION® implant assemblies.

The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136. F1295, F1472, F67, F1537 and F138. All other REVERE® implants are composed of titanium alloy, stainless steel, and cobalt chromium molybdenum alloy, as specified in ASTM F136, F1295, F138, and F1537. The screws are available with hydroxyapatite (HA) coating, as specified in ASTM F1185. Due to the risk of galvanic corrosion following implantation, stainless steel implants

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should not be connected to titanium, titanium allov, or cobalt chromiummolybdenum.

#### Indication for Use:

The REVERE® Stabilization System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic. lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor. pseudoarthrosis and failed previous fusion.

In addition, the REVERE® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as a posterior non-pedicle screw fixation system, the REVERE® Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, and/or fordosis, Scheuermann's disease). fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the REVERE® Stabilization System is intended for anterolateral screw (with staples or staple plates) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

#### Technological Characteristics:

The technological characteristics of the REVERE® Stabilization System additional implants are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics.

#### Performance Data:

Mechanical testing (static and dynamic compression, static torsion, and static screw head pull-off) was conducted in accordance with ASTM F1717 and the

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"Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device.

## Basis of Substantial Equivalence:

REVERE® additional implants are similar to the predicate devices with respect to technical characteristics, material, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. REVERE® additional implants perform as well as or better than the predicate devices.

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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

**DEPARTMENT OF HEALTH**

March 11, 2014

Globus Medical, Incorporated Ms. Christina Kichula Group Manager. Regulatory Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K133350

Trade/Device Name: REVERE® Stabilization System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP, KWQ Dated: February 10, 2014 Received: February 11, 2014

Dear Ms. Kichula:

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. Christina Kichula

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins

- 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

K133350 510(k) Number:

Device Name: REVERE® Stabilization System

## INDICATIONS:

The REVERE® Stabilization System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the REVERE® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as a posterior non-pedicle screw fixation system, the REVERE® Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, turnor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrumfilium.

When used as an anterolateral thoracolumbar system, the REVERE® Stabilization System is intended for anterolateral screw (with or without staples or staple plates) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, turnor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

OR Over-The-Counter Use Prescription Use × (Per 21 CFR \$801.109)

(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: K133350