PERIMETER INTERBODY FUSION DEVICE

K090353 · Medtronic Sofamor Danek · MAX · Sep 29, 2009 · Orthopedic

Device Facts

• Record ID: K090353
• Device Name: PERIMETER INTERBODY FUSION DEVICE
• Applicant: Medtronic Sofamor Danek
• Product Code: MAX · Orthopedic
• Decision Date: Sep 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PERIMETER® Interbody Fusion Device is indicated for use 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.

Device Story

PERIMETER® Interbody Fusion Device consists of hollow cages for lumbar or lumbosacral interbody fusion; implanted between vertebral bodies to provide support and correction. Implants packed with autogenous bone graft; feature teeth on superior/inferior surfaces for expulsion resistance. Used in conjunction with supplemental fixation instrumentation. Implanted by surgeons via open or minimally invasive approaches (anterior, lateral, oblique). Device provides structural support to facilitate fusion in patients with degenerative disc disease; benefits include stabilization of spinal segments and potential reduction of discogenic back pain.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Titanium alloy and PEEK (polyetheretherketone). Geometry: Hollow cage with superior/inferior surface teeth. Dimensions: 8mm-20mm height, 19mm-28mm width. Sterilization: Provided in sterile and non-sterile forms.

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, who have failed six 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

• CLYDESDALE® Spinal System (K083026)
• LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015)
• BAK® Cage (P950002)
• RAY® Threaded Fusion Cage (P950019)
• Lumbar I/F Cage (P960025)
• CAPSTONE® Spinal System (K073291)
• VERTE-STACK® Spinal System (K041452)

Submission Summary (Full Text)

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# PERIMETER® Interbody Fusion Device 510(k) Summary February 2009

| Company: | Medtronic Sofamor Danek |
|----------|-------------------------|
| | 1800 Pyramid Place |
| | Memphis, TN 38132 |
| | [phone] |

SEP & 8 2009

Lee Grant Contact: Principal, Regulatory Affairs

#### Proprietary Trade Name: PERIMETER® Interbody Fusion Device II.

Classification Name: Intervertebral Body Fusion Device (21 CFR 888.3080) III.

- IV. Product Code: MAX
#### Product Description V.

The PERIMETER® Interbody Fusion Device consists of cages 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.

This device is offered in both titanium alloy and PEEK

(POLYETHERETHERKETONE) versions. This interbody device is provided in both sterile and non-sterile forms. Refer to the package label for sterility information.

The subject PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height and between 19mm and 28mm in width. The device is designed with teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance.

#### V. Indications

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

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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.

#### Substantial Equivalence VI.

Documentation, including mechanical test results and published literature, was provided which demonstrated that the subject PERIMETER® Interbody Fusion Device is substantially equivalent to several recently down classified interbody cages including, the CLYDESDALE® Spinal System (K083026, SE 12/29/08); the LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03); the BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03); the RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03); the Lumbar I/F Cage (DePuy, P960025); as well as to the CAPSTONE® Spinal System K073291 (SE 04/24/08) and the VERTE-STACK® Spinal System (K041452, SF. 06/24/04).

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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 consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.

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

Medtronic Sofamor Danek % Mr. Lee Grant Principal, Regulatory Affairs 1800 Pyramid Place Memphis. Tennessee 38132

SEP. 2 9 2009

Re: K090353

Trade Name: PERIMETER® Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: II Product Code: MAX Dated: September 21, 2009 Received: September 22, 2009

Dear Mr. Grant:

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.

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 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.

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## Page 2 - Mr. Lee Grant

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,

Sincerely yours,

Mark M. Milkeran

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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510(k) Number (if known):

Device Name: PERIMETER® Interbody Fusion Device

### Indications for Use:

The PERIMETER® Interbody Fusion Device is indicated for use 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M Milhum

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

510(k) Number_ KO90353