TRANSITION STABILIZATION SYSTEM

K073439 · Globus Medical, Inc. · NQP · Feb 20, 2009 · Orthopedic

Device Facts

• Record ID: K073439
• Device Name: TRANSITION STABILIZATION SYSTEM
• Applicant: Globus Medical, Inc.
• Product Code: NQP · Orthopedic
• Decision Date: Feb 20, 2009
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TRANSITION™ Stabilization System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine in skeletally mature patients: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis). In addition, the TRANSITION™ Stabilization System is indicated for use in patients: who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and who are having the device removed after the development of a solid fusion mass. TRANSITION™ is only indicated for use when fusion with autogenous bone graft is being performed at all instrumented levels.

Device Story

TRANSITION™ Stabilization System provides spinal immobilization/stabilization as an adjunct to fusion. Implants include pedicle screws (HA-coated) and assemblies (PET cord, PCU spacers/bumpers, titanium alloy spools). Assemblies connect to pedicle screws via REVERE® locking caps. Used in thoracic, lumbar, and sacral spine. Surgeon-operated in clinical/OR setting. Provides rigid connection to stabilize spinal segments during fusion healing. Benefits patient by supporting spinal alignment and stability during bone graft consolidation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium alloy (Ti6Al4V ASTM F136 or Ti6Al7Nb ASTM F1295), PET, PCU. Screws HA-coated (ASTM F1185). Components: Pedicle screws, PET cord, PCU spacers/bumpers, titanium spools. Connectivity: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with acute/chronic thoracic, lumbar, or sacral spine instabilities/deformities (degenerative spondylolisthesis with neurologic impairment, kyphosis, pseudoarthrosis). Requires fusion with autogenous bone graft at all instrumented levels. Contraindicated for use without fusion.

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 (K061202)
• Dynesys (K031511)

Submission Summary (Full Text)

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# ko73439

## 510(k) SUMMARY: TRANSITION™ STABILIZATION SYSTEM

| Company: | Globus Medical Inc. |
|----------|-----------------------------------------|
| | 2560 General Armistead Ave. |
| | Audubon, PA 19403 |
| | [phone] |
| Contact: | Kelly J. Baker, Ph.D |
| | Director, Clinical Affairs & Regulatory |

FEB 2 0 2009

Device Name: TRANSITION™ Stabilization System

Classification: Product Code NQP. Class II. 21 CFR \$888.3070 Pedicle Screw Spinal System

REVERE (K061202), Dynesys (K031511) Predicate(s):

#### Device Description:

The TRANSITION™ Stabilization System implants include pedicle screws and implant assemblies which are provided pre-assembled or can be assembled intraoperatively.

TRANSITION™ pedicle screws are coated with hydroxyapatite (HA). Either TRANSITION™ HA coated pedicle screws or specified REVERE® pedicle screws may be used in conjunction with the implant assemblies. Specifically, REVERE® polyaxial (solid, cannulated and dual outer diameter) screws and monoaxial screws 6.5mm diameter and larger, and 35mm length and larger, may be used with the TRANSITION™ implant assemblies.

Implant assemblies consist of a polyethylene terepthalate (PET) cord, polycarbonate urethane (PCU) spacers and bumpers, and titanium alloy spools, end spools and set screw ends. The cord passes through the entire implant such that the spools are positioned to sit within the screw heads and the spacer sits between the spools. The end spool includes one end of the secured cord. The bumper followed by a set screw end is positioned at the other end of the cord.

Implant assemblies are available in single or multi-level configurations. REVERE® locking caps with inner set screws are used to rigidly connect the pedicle screws to the implant assemblies.

TRANSITION™ implants are available in a variety of sizes to accommodate varied patient anatomy.

TRANSITION™ implants are manufactured from titanium alloy Ti6AI4V (ASTM F136) or Ti6Al7Nb (ASTM F1295), polyethylene terepthalate (PET), and/or polycarbonate urethane (PCU). Titanium alloy TRANSITION™ screws are hydroxyapatite (HA) coated (ASTM F1185).

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K073439

### Intended Use/Indications for Use:

The TRANSITION™ Stabilization System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine in skeletally mature patients: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis).

In addition, the TRANSITION™ Stabilization System is indicated for use in patients: who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and who are having the device removed after the development of a solid fusion mass.

TRANSITION™ is only indicated for use when fusion with autogenous bone graft is being performed at all instrumented levels.

#### Basis for Substantial Equivalence:

The TRANSITION™ Stabilization System has been found to be substantially equivalent to the previously cleared predicate devices in terms of indications for use, design, function, and materials.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, with its wings spread.

#### Public Health Service .

FEB 2 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Medical Inc. % Kelly J. Baker, PhD Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K073439

Trade/Device Name: TRANSITION™ Stabilization System Regulation Number: 21 CFR 888.3070 -Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: NOP Dated: November 24, 2008 Received: November 25, 2008

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device has not been established for the intended use of spinal stabilization without fusion. This device is only intended to be used when fusion with autogenous bone graft is being performed at all instrumented levels.

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Page 2 - Kelly J. Baker, PhD

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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); good manufacturing practice requirements as set 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

510(k) Number: K073439

Device Name: TRANSITION™ Stabilization System

#### Indications:

The TRANSITION™ Stabilization System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine in skeletally mature patients. degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis).

In addition, the TRANSITION™ Stabilization System is indicated for use in patients: who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and who are having the device removed after the development of a solid fusion mass.

TRANSITION™ is only indicated for use when fusion with autogenous bone graft is being performed at all instrumented levels.

Prescription Use × (Per 21 CFR §801.109) OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

(Division Sign-Off) (Division Sign-Oral, Restorative, Division of Neurological Devices

510(k) Number