PERIMETER INTERBODY FUSION DEVICE

K111525 · Medtronic Sofamor Danek · MAX · Aug 24, 2011 · Orthopedic

Device Facts

• Record ID: K111525
• Device Name: PERIMETER INTERBODY FUSION DEVICE
• Applicant: Medtronic Sofamor Danek
• Product Code: MAX · Orthopedic
• Decision Date: Aug 24, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Device Story

PERIMETER® Interbody Fusion Device consists of hollow cages inserted between lumbar or lumbosacral vertebral bodies to provide support and correction during fusion surgery. Implants are packed with autogenous bone graft; designed with surface teeth for expulsion resistance. Offered in Titanium Alloy or PEEK Optima LT1; titanium versions include lateral windows for graft visibility. Used in open or minimally invasive (anterior, lateral, oblique) approaches. Requires supplemental fixation instrumentation. Physician-operated in surgical settings. Benefits include structural support and stabilization of vertebral segments in DDD patients.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via dynamic axial compression, bending, and static compression shear testing in accordance with ASTM 2077-03, supplemented by finite element analysis.

Technological Characteristics

Materials: Titanium-6Aluminum-4Vanadium ELI or PEEK Optima LT1. Dimensions: 8-20mm height, 21-28mm length, 19-38mm width; 4-15 degrees lordosis. Design: Hollow geometry with surface teeth for endplate grip; lateral windows on titanium versions. Sterilization: Provided sterile. Testing: ASTM 2077-03.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade 1 Spondylolisthesis or retrolisthesis. Requires six months of prior non-operative treatment. Used with autogenous bone graft and supplemental fixation.

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

• PERIMETER® Interbody Fusion Device (K090353)

Submission Summary (Full Text)

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K111525 510(k) Summary

AUG 2 4 2011

### MEDTRONIC Sofamor Danek PERIMETER® Interbody Fusion Device August 2011

| I. | Company: | Medtronic Sofamor Danek, Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>[phone] |
|-----|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: | Michael Scott<br>Sr. Regulatory Affairs Specialist |
| II. | Product Name:<br>Common Name:<br>Classification Name:<br>Classification Panel:<br>Regulation:<br>Product Code(s) | PERIMETER® Interbody Fusion Device<br>Interbody Fusion Device<br>Intervertebral Body Fusion Device<br>Class II (special controls)<br>21 CFR 888.3080<br>MAX |

III. Description: The PERIMETER® Interbody Fusion Device consists of cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The PERIMETER® Interbody Device is to be used with supplemental instrumentation.

The device is offered in Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI ) or PEEK Optima LT1 (Polyetheretherketone). This interbody device is provided in sterile forms. Refer to the package label for specific implant sterility information.

The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 21mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK Optima LT1 and Titanium Alloy devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy version of this device offers lateral windows for visibility of the Autogenous bone graft.

Based on fatigue testing results, when using the PERIMETER Interbody Fusion Device, the physician/surgeon should consider the levels of implantation, patient activity level, other patient conditions, etc., which may impact on the performance of this system.

# Never use stainless steel and titanium implant components in the same construct.

Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. PEEK Optima-LT1 implants may be used with stainless steel, titanium, or cobaltchromium-molybdenum alloy implants.

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#### Indications for Use:

The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

## Substantial Equivalence:

The subject PERIMETER® Interbody Fusion Device System is substantially equivalent to the predicate PERIMETER® Interbody Fusion Device (K090353 (S.E. 09/29/2009)) in terms of fundamental technology, intended use, indications for use and intervertebral body design and fundamental scientific technology.

#### IV. Technological Characteristics:

The purpose of this 510(k) is to include additional titanium versions of the PERIMETER® Interbody Fusion Device System. A revised surgical technique and IFU with the updated information to include the titanium version has also been included in this 510(k) submission.

The subject and predicate PERIMETER® Interbody Fusion Device are identical in terms of indications for use, intended use and performance specifications.

# SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*

| Performance Test Summary-New Device | | |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Dynamic Axial Compression<br>Bending | ASTM 2077-03 "Test Methods<br>for Intervertebral | The subject device successfully met all acceptance<br>criteria for these tests. |
| Static Compression Bending<br>Static Compression Shear | Body Fusion Devices"<br>An Finite Element Analysis in<br>line with ASTM 2077-03 was<br>used to assess Static<br>Compression Bending and<br>Static Compression Shear | Additional documentation was provided which<br>demonstrated the subject intervertebral devices to be<br>substantially equivalent to the predicate<br>PERIMETER® Interbody Fusion Device |

# Conclusions Drawn from the Non-Clinical Tests

The subject PERIMETER® Interbody Fusion Device System is substantially equivalent to the predicate

PERIMETER® Interbody Fusion Device (K090353 (S.E. 09/29/2009)) in terms of fundamental technology,

intended use, indications for use and intervertebral body design and fundamental scientific technology.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

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

AUG 2 4 2011

Medtronic Sofamor Danek, Inc. % Mr. Michael Scott Sr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K111525 ·

Trade/Device Name: PERIMETER® Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 22, 2011 Received: July 25, 2011

Dear Mr. Scott:

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 - Mr. Michael Scott

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Emil Keith

Co 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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#### KIII525 510(k) Number (if known):

Device Name: PERIMETER® Interbody Fusion Device

### Indications for Use:

The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use Per 21 CFR 801.109

Over-The-Counter Use --------

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Diysion of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111525