CALIBER SPACER

K102293 · Globus Medical, Inc. · MAX · Jan 5, 2011 · Orthopedic

Device Facts

• Record ID: K102293
• Device Name: CALIBER SPACER
• Applicant: Globus Medical, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jan 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CALIBER™ Spacers are interbody fusion devices 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). CALIBER™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE® or REVOLVE™ Stabilization Systems.

Device Story

CALIBER™ Spacer is an interbody fusion device designed to provide structural stability in the lumbar spine following discectomy. The device is implanted by a surgeon during spinal fusion procedures. It features an expandable design to accommodate various surgical approaches (posterior, transforaminal, or lateral) and anatomical needs. The spacer is filled with autogenous bone graft material to promote fusion and must be used with supplemental fixation systems (e.g., REVERE® or REVOLVE™). Protrusions on the superior and inferior surfaces grip vertebral endplates to resist expulsion. The device provides mechanical support to the disc space, facilitating spinal fusion and potentially alleviating discogenic back pain.

Clinical Evidence

Bench testing only. Mechanical performance was evaluated through static and dynamic compression, static and dynamic compression-shear, and subsidence testing in accordance with the "Class II Special Controls Guidance Document: Intervertebral Fusion Device" and ASTM F2077.

Technological Characteristics

Materials: PEEK polymer (ASTM F2026) and titanium alloy (ASTM F136, F1295); non-expanding versions are PEEK only. Markers: Titanium alloy or tantalum (ASTM F560). Design: Expandable and non-expanding lumbar interbody spacers with surface protrusions for endplate fixation. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

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 those with up to Grade 1 spondylolisthesis or retrolisthesis, who have failed at least 6 months of non-operative 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

• Globus PATRIOT® Spacers (K072970 & K093242)
• Kiscomedica L-Varlock™ Lumbar Cages (K080537)

Submission Summary (Full Text)

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1102293

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# 510(k) Summary: CALIBER™ Spacer

| JAN | - 5 | 2011 |
|-----|-----|------|
|-----|-----|------|

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

Date Prepared: August 12, 2010

Device Name: CALIBER™ Spacer

- Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion device. Product Code MAX. Regulatory Class II, Panel Code 87
- Globus PATRIOT® Spacers (K072970 & K093242) Predicate(s): Kiscomedica L-Varlock™ Lumbar Cages (K080537)

### Purpose:

The purpose of this submission is the addition of CALIBER™ Spacers to the PATRIOT® Lumbar Spacers.

### Device Description:

CALIBER™ Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. CALIBER™ Spacers are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral) or lateral) and can expand to the desired height. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

CALIBER™ Spacers are manufactured from radiolucent PEEK polymer and titanium alloy per ASTM F2026, F136 and F1295; non-expanding CALIBER™ Spacers are manufactured from PEEK only. CALIBER™ Spacers contain radiopaque titanium alloy or tantalum markers as specified in ASTM F136, F1295 and F560.

### Indications for Use:

CALIBER™ Spacers are interbody fusion devices 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

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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).

CALIBER™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE® or REVOLVE™ Stabilization Systems.

#### Performance Data:

Mechanical testing consisting of static and dynamic compression, static and dynamic compression-shear and subsidence was conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007 and ASTM F2077 to demonstrate substantial equivalence to the predicate system(s).

### Basis for Substantial Equivalence:

CALIBER™ Spacers are similar to the predicate systems with respect to technical characteristics, performance and intended use. The information provided within this premarket notification supports substantial equivalence of the subject spacers to the predicate device(s).

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

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

JAN - 5 2011

Re: K102293

Trade/Device Name: CALIBER™ Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 28, 2010 Received: December 29, 2010

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 (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

JAN - 5 2011

KID2293 510(k) Number:

Device Name: CALIBER™ Spacer

Indications:

CALIBER™ Spacers are interbody fusion devices 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

CALIBER™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE® or REVOLVE™ Stabilization Systems.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

KIO 2293 510(k) Number_