CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM

K111264 · Medtronic Sofamor Danek USA · ODP · Oct 12, 2011 · Orthopedic

Device Facts

• Record ID: K111264
• Device Name: CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM
• Applicant: Medtronic Sofamor Danek USA
• Product Code: ODP · Orthopedic
• Decision Date: Oct 12, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CORNERSTONE® PSR Cervical device is indicated for 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. 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. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.

Device Story

CORNERSTONE® PSR Cervical Fusion System is an interbody spacer for cervical fusion; implanted via open, anterior approach by surgeons. Device features hollow geometry for autograft packing; provides structural support and correction between cervical vertebral bodies until fusion occurs. Implant includes tantalum or titanium alloy markers for radiographic visualization. Used in conjunction with supplemental fixation and autograft. Benefits include stabilization of cervical spine segments in patients with disc disease.

Clinical Evidence

Bench testing only. Pre-clinical studies included static and dynamic compression, torsion, and compression shear per ASTM F2077-03, subsidence per ASTM F2267-04, and expulsion testing. No clinical data presented.

Technological Characteristics

Interbody fusion spacer; material: PEEK-OPTIMA® LT1 (ASTM F2026); markers: tantalum (ASTM F-560) or titanium alloy (ASTM F-136). Features hollow geometry for bone graft; available in various heights and 4º lordotic angle. Implanted via open anterior approach.

Indications for Use

Indicated for skeletally mature patients with cervical disc disease (intractable radiculopathy/myelopathy, herniated disc, or osteophyte formation with nerve root/spinal cord compression) at one level from C2-C3 to C7-T1, following six weeks of failed 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

• CORNERSTONE® PSR Cervical Interbody Fusion Device (K100214)
• VERTE-STACK® Spinal System (K041197)
• PLATEAU® (PLATEAU-C) Spacer System (K093093)
• BENGAL® System (K081917)

Submission Summary (Full Text)

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#### Page 1/2 KITI 264

OCT 1 2 2011

# CORNERSTONE® PSR Cervical Fusion System Interbody Fusion Device 510(k) Summary May 2011

I. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 [phone]

Regina Holmes Contact: Senior Regulatory Affairs Specialist

II. Proprietary Trade Name: CORNERSTONE® PSR Cervical Fusion System

Classification Name: Intervertebral Body Fusion Device

Product Code: ODP (21 CFR 888.3080)

Common Name: Cervical Interbody Fusion Device

## III. Product Description

The CORNERSTONE® PSR Cervical Fusion System consists of spacers which can be inserted between two cervical vertebral bodies to give support and correction until fusion occurs. The hollow geometry of the implant allows it to be packed with autogeneous bone graft. The CORNERSTONE® PSR Cervical Fusion System also includes instrumentation that enables the surgeon to implant the devices via an open, anterior approach.

The device sizes are available in various heights and in a 4º lordotic angle option. The implant devices are manufactured from medical grade polyetheretherketone (PEEK -OPTIMA® LT1) per ASTM F2026 and also contain either tantalum markers per ASTM F-560 or titanium alloy markers per ASTM F-136 so that the position of the implant can be determined on X-ray or other imaging.

### IV. Indications for Use

The CORNERSTONE® PSR Cervical device is indicated for 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. 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

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radiographic studies. This device is to be used in patients who have had six weeks of nonoperative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.

## V. Performance Data

The following pre-clinical studies were conducted using worst case CORNERSTONE® PSR devices: static and dynamic compression, static and dynamic torsion, static and dynamic compression shear per ASTM F2077-03; subsidence per ASTM F2267-04; and expulsion. The results of these studies were found to be substantially equivalent to legally marketed devices.

## VI. Substantial Equivalence

Documentation was provided which demonstrated that the subject device is substantially equivalent to the following currently marketed devices: CORNERSTONE® PSR Cervical Interbody Fusion Device (K100214, SE 6/25/2010); VERTE-STACK® Spinal System (K041197, SE 8/9/2004); PLATEAU® (PLATEAU-C) Spacer System (K093093, Life Spine, SE 10/13/2010); and BENGAL® System (K081917, DePuy, SE 5/22/2009).

## VII. Conclusion

It was determined that the subject device is substantially equivalent in design, materials, function, indications for use, and scientific technology to the predicate devices presented.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services of the USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. The seal is in black and white.

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

OCT 1 2 2011

Medtronic Sofamor Danek % Ms. Regina Holmes Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: KI11264

Trade/Device Name: CORNERSTONE® PSR Cervical Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 14, 2011 Received: September 15, 2011

Dear Ms. Holmes:

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 - Ms. Regina Holmes

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/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 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: CORNERSTONE® PSR Cervical Fusion System

## Indications for Use:

The CORNERSTONE® PSR Cervical device is indicated for 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. 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. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.

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)

| (Division Sign-Off) | |
|-----------------------------------------------------------|---------|
| Division of Surgical, Orthopedic, And Restorative Devices | |
| 510(k) Number | K111264 |