INTERCONTINENTAL PLATE-SPACER

K103382 · Globus Medical, Inc. · OVD · May 20, 2011 · Orthopedic

Device Facts

• Record ID: K103382
• Device Name: INTERCONTINENTAL PLATE-SPACER
• Applicant: Globus Medical, Inc.
• Product Code: OVD · Orthopedic
• Decision Date: May 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InterContinental™ Plate-Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The InterContinental™ Plate-Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation in addition to the integrated screws.

Device Story

InterContinental™ Plate-Spacer is a lateral lumbar interbody fusion device; provides structural stability following discectomy. Device consists of radiolucent polymer spacer with titanium alloy or tantalum markers; includes titanium alloy bone screws (optional hydroxyapatite coating). Implant filled with autogenous bone graft; screws provide bony fixation to lateral vertebral bodies. Used in surgical setting by physicians; requires supplemental fixation. Benefits include stabilization of spinal segments in DDD patients.

Clinical Evidence

Bench testing only. Mechanical testing performed per 'Class II Special Controls Guidance Document: Intervertebral Fusion Device' (2007) including static and dynamic compression, compression-shear, subsidence, expulsion, and fatigue bending.

Technological Characteristics

Spacer: radiolucent polymer with titanium alloy/tantalum markers (ASTM F136, F560, F1295, F2026). Plates/Screws: titanium alloy (ASTM F136, F1295). Screws: optional hydroxyapatite coating (ASTM F1185). Mechanical fixation via integrated screws and supplemental fixation.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1), including up to Grade 1 spondylolisthesis or retrolisthesis, who have failed at least six months of nonoperative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• INDEPENDENCE® Spacer (K082252)
• PATRIOT® TransContinental™ LLIF Spacer (K093242)
• CoRoent® XL-F (K071795)

Submission Summary (Full Text)

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MAY 2 0 2011

# 510(k) SUMMARY: InterContinental™ Plate-Spacer

| Company: | Globus Medical Inc.<br>2560 General Armistead Avenue<br>Audubon, PA 19403<br>[phone] |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D.<br>Vice President, Regulatory & Clinical Affairs |
| Date Prepared: | March 10, 2011 |
| Device Name: | InterContinental™ Plate-Spacer |
| Classification: | Per 21 CFR as follows:<br>§888.3080: Intervertebral Body Fusion Device<br>Product Code: OVD<br>Regulatory Class: II, Panel Code: 87 |
| Predicate(s): | INDEPENDENCE® Spacer (K082252)<br>PATRIOT® TransContinental™ LLIF Spacer (K093242<br>CoRoent® XL-F (K071795) |

## Purpose:

The purpose of this submission is clearance of the InterContinental™ Plate- Spacer as a modification of the cleared INDEPENDENCE® device.

### Device Description:

The InterContinental™ Plate-Spacer is a lateral lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. InterContinental™ is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to aid in expulsion resistance. InterContinental™ is to be filled with autogenous bone graft material, and is to be used with titanium alloy bone screws, with or without hydroxyapatite coating. Bone screws are used to attach to the lateral portion of the adjacent vertebral bodies for bony fixation.

The spacer in the InterContinental™ Plate-Spacer is manufactured from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. The plates in the InterContinental™ Plate-Spacer are manufactured from titanium alloy, as specified in ASTM F136, and F1295. The screws in the InterContinental™ Plate-Spacer are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.

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#### Indications for Use:

The InterContinental™ Plate-Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The InterContinental™ Plate-Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation in addition to the integrated screws.

#### Performance Data:

Mechanical testing consisting of static and dynamic compression, static and dynamic compression-shear, subsidence, expulsion, and fatigue bending was conducted by in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, to demonstrate substantial equivalence to the predicate devices.

### Basis for Substantial Equivalence:

The InterContinental™ Plate-Spacer has been found to be substantially equivalent to the predicates with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.

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

MAY 2 0 2011

Globus Medical Inc. % Kelly J. Baker, Ph.D. Vice President, Regulatory & Clinical Affairs 2560 General Armistead Avenue Audubon. Pennsylvania 19403

Re: K103382

Trade/Device Name: InterContinental™ Plate-Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: April 15, 2011 -Received :- April 18-201-1-

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

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Page 2 - Kelly J. Baker, Ph.D.

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

K. B. M.
for.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

K103382 510(k) Number:

InterContinental™ Plate-Spacer_ Device Name:

#### INDICATIONS:

The InterContinental™ Plate-Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The InterContinental™ Plate-Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation in addition to the integrated screws.

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- i Prescription Use ____________________________________________________________________________________________________________________________________________________________ OR OR OR (Per 21 CFR §801.109)

Over-The-Counter Use_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIO 3382 510(k) Number_