PERIMETER C SPINAL SYSTEM

K132584 · Medtronic Sofamor Danek USA, Inc. · ODP · Dec 4, 2013 · Orthopedic

Device Facts

• Record ID: K132584
• Device Name: PERIMETER C SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Dec 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.

Device Story

PERIMETER® C Spinal System consists of titanium alloy (Ti-6Al-4V ELI) interbody cages/spacers; designed for anterior cervical interbody fusion. Implants feature hollow geometry for autogenous bone graft packing; superior/inferior teeth resist expulsion; lateral windows allow visualization of graft. Used in clinical settings by surgeons via open, anterior approach. Provides structural support and correction during fusion; requires supplemental fixation. Benefits patients by stabilizing cervical segments and facilitating fusion in cases of symptomatic nerve root or spinal cord compression.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical mechanical testing, including static and dynamic torsion, compression, bending, and shear testing (ASTM F2077), subsidence testing (ASTM F2267), and expulsion testing.

Technological Characteristics

Interbody cages manufactured from medical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Features include lateral windows for graft visibility, hollow geometry, and serrated superior/inferior surfaces. Provided non-sterile. Implanted via open, anterior approach. Mechanical performance validated via ASTM F2077 and ASTM F2267 standards.

Indications for Use

Indicated for anterior cervical interbody fusion in skeletally mature patients with cervical disc disease (intractable radiculopathy/myelopathy, herniated disc, or osteophyte formation) at one level (C2-C3 to C7-T1) after 6 weeks of failed non-operative treatment. Requires use with autogenous bone graft and supplemental fixation via open anterior approach.

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® C Spinal System (K100967)
• AFFINITY® Anterior Cervical Cage System (P000028)
• BAK/C® Cervical Interbody Fusion System (P980048)
• CORNERSTONE® PSR Spinal System (K100214)
• ANATOMIC PEEK™ Spinal System (K112444)

Submission Summary (Full Text)

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## PERIMETER® C Spinal System 510(k) Summary

## December 2013

Medtronic Sofamor Danek USA. Inc. l. Company: 1800 Pyramid Place Memphis. TN 38132 Telephone: [phone] Fax: [phone]

| II. Contact: | Michael Scott<br>Senior Regulatory Affairs Specialist |
|------------------------------|-------------------------------------------------------|
| III. Proprietary Trade Name: | PERIMETER® C Spinal System |
| IV. Classification Name: | Intervertebral Body Fusion Device (21.CFR 888.3080) |
| V. Class: | II |
| VI. Product Code: | ODP |

#### VII. Product Description:

The PERIMETER® C Spinal System consists of spacers/cages of various widths and heights, which can be inserted between two cervical bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures.

The purpose of this submission is to include additional interbody cages manufactured from medical grade titanium alloy (Ti-6A1-4V ELI) and designed with lateral windows. The lateral windows allow for visibility of bone graft placement. The subject device is offered in a non-sterile form.

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#### VIII. Indications:

The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of nonoperative treatment. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.

#### Identification of Legally Marketed Predicate Devices Used to Claim Substantial IX. Equivalence:

In order to demonstrate substantial equivalence to legally marketed predicate device(s), PERIMETER® C Spinal System (K100967, S.E. 08/05/2011) is used as the primary predicate in terms of indications for use, intended use, fundamental scientific technology. and performance and technological characteristics.

AFFINITY® Anterior Cervical Cage System (P000028, Approval Date 06/13/2002, Down Classified to a Class II special control. Date of Final Order 06/12/2007), BAK/C® Cervical Interbody Fusion System (P980048, Approval Date 10/06/2004, Down Classified to a Class II special control. Date of Final Order 06/12/2007). CORNERSTONE® PSR Spinal System (K100214, S.E. 06/25/2010), and ANATOMIC PEEK™ Spinal System (K112444, S.E. 11/16/2011) are additionally used as predicates for this submission to demonstrate the material and performance of the subject device are substantially equivalent to other legally marketed interbody fusion devices.

#### X. Summary of the Technological Characteristics:

The subject and predicate PERIMETER® C Spinal System cages are identical in terms of indications for use, intended use, fundamental scientific technology, and performance and technological characteristics. The subject PERIMETER® C Spinal System is a modification to the predicate PERIMETER® C Spinal System (K100967, S.E. 08/05/2011). The subject devices comprises of interbody cages manufactured from medical grade titanium alloy (Ti-6A1-4V ELI) per ASTM F136, and include lateral windows. The lateral windows allow for visibility of bone graft placement. The subject devices are to be used with autogenous bone graft and supplemental fixation. The subject implants are provided non-sterile. The PERIMETER® C Spinal System implants are implanted via an open, anterior approach.

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#### Discussion of Non-Clinical Testing: XI.

An assessment of the device modifications was completed in accordance with Medtronic design control processes.

Mechanical testing was conducted according to FDA guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices". For a determination of substantial equivalence. the following non-clinical mechanical tests and Finite Element Analysis (FEA) was performed:

| Tests Performed | Applicable Standards |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Static Torsion Testing | |
| Static Compression Bending Testing | |
| Static Compression Shear Testing | ASTM F2077 |
| Dynamic Torsion Testing | (Test Methods for Intervertebral Body<br>Fusion Devices) |
| Dynamic Compression Bending<br>Testing | |
| Dynamic Compression Shear Testing | |
| Subsidence Testing | ASTM F2267<br>(Standard Test Method for Measuring<br>Load Induced Subsidence of the<br>Intervertebral Body Fusion Device under<br>Static Axial Compression) |
| | |
| | |
| | |
| Expulsion Testing Rationale | DRAFT ASTM F-04.25.02.02 |

The subject device successfully met all the predetermined acceptance criteria. Based on the results the subject intervertebral devices demonstrated that they are as safe and effective as the predicate device(s).

#### Discussion of Clinical Testing: XII.

No clinical testing was performed.

#### XIII. Conclusions Drawn from the Non-Clinical Tests:

Based on the risk analysis, test results and additional supporting documentation provided in this pre-market notification. the subject PERIMETER® C Spinal System demonstrates substantial equivalence to the predicate device(s).

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

December 4, 2013

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

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

Re: K132584

Trade/Device Name: PERIMETER C SPINAL SYSTEM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: October 25, 2013 Received: October 28, 2013

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 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

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### Page 2 - Mr. Michael Scott

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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 -S

Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known) K132584

#### Device Name PERIMETER C SPINAL SYSTEM

#### Indications for Use (Describe)

The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of aon-operative treatment. Cervical disc disease is defined as intractable radior myelopathy with hermated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal confirmed by radiographic studies. Additionally, the PERMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

COLLECT FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR

Concurrence of Center for Devices and Radiological Haath (CDRH) (Signature)

## nton E. Dmitriev. Pr

# Divisio

FORM FDA 3881 (9/13)

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