ANATOMIC PEEK CERVICAL FUSION SYSTEM

K112444 · Medtronic Sofamor Danck USA, Inc. · ODP · Nov 15, 2011 · Orthopedic

Device Facts

• Record ID: K112444
• Device Name: ANATOMIC PEEK CERVICAL FUSION SYSTEM
• Applicant: Medtronic Sofamor Danck USA, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Nov 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ANATOMIC PEEK CERVICAL FUSION SYSTEM 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 ANATOMIC® PEEK™ device is to be used with supplemental fixation. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach.

Device Story

ANATOMIC PEEK CERVICAL FUSION SYSTEM consists of hemicylindrical cages of varying dimensions; manufactured from PEEK OPTIMA. Used in cervical fusion procedures to provide structural support between vertebral bodies. Implanted by surgeons via open, anterior approach; packed with autogenous bone graft. Requires concurrent use of cleared cervical supplemental fixation. Device maintains disc space height and facilitates fusion; benefits patients by alleviating symptomatic nerve root or spinal cord compression caused by disc disease.

Clinical Evidence

Bench testing only. Testing conducted per ASTM F2077-03, ASTM F2267-04, and draft static push-out test method. Evaluated static compression, static compression shear, compression fatigue, compression shear fatigue, static torsion, torsion fatigue, static subsidence, and static expulsion. All results met predetermined acceptance criteria.

Technological Characteristics

Material: PEEK OPTIMA. Form factor: Hemicylindrical cages of various widths, heights, and depths. Hollow geometry for autogenous bone graft. Standards: ASTM F2077-03, ASTM F2267-04, and draft static push-out test method. Mechanical device; no energy source or software.

Indications for Use

Indicated for cervical interbody fusion in skeletally mature patients with cervical disc disease (intractable radiculopathy/myelopathy, herniated disc, or osteophyte formation) at one level from C2-C3 to C7-T1. Requires six weeks of failed non-operative treatment. Must be used with supplemental fixation and autogenous bone graft 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

• VERTE-STACK Anatomic PEEK Spinal System (K070173)
• CORNERSTONE PSR Cervical Interbody Fusion Device (K100214)
• PEEK PREVAIL Cervical Interbody Device (K094042)
• Depuy Bengal System (K081917)
• Small PLATEAU (Plateau-C) (K093093)

Submission Summary (Full Text)

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Fax: [phone]

### MEDTRONIC Sofamor Danek ANATOMIC PEEK™ CERVICAL FUSION SYSTEM November 2011

- Medtronic Sofamor Danek, USA Company: Inc. 1800 Pyramid Place Memphis, Tennessee 38132 [phone] II. Becky Ronner Contact: Regulatory Affairs Specialist Telephone: [phone]
- ANATOMIC PEEK™ CERVICAL III. Proposed Proprietary Trade Name: FUSION SYSTEM
- IV. Classification Names: Intervertebral Body Fusion Device Class: 11 Product Code: ODP (21 CFR 888.3080)

### V. Description:

I.

The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is designed for use as a cervical interbody fusion device. The device is manufactured from PEEK™ OPTIMA™ and is to be used with autogenous bone graft.

The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM consists hemicylindrical of cages of various widths, heights and depths. The hollow geometry of the implants allows them to be inserted between two cervical vertebral bodies packed with autogenous bone graft in cervical fusion procedures. The ANATOMIC PEEK™ device is to be used with cleared cervical supplemental fixation.

#### VI. Indications for Use:

The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM 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

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# K112444

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 ANATOMIC® PEEK™ device is to be used with supplemental fixation. The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach.

### Summary of the Technological Characteristics: VII.

The purpose of this 510(k) submission is to seek clearance for a cervical interbody fusion indication for the ANATOMIC PEEK™ CERVICAL FUSION SYSTEM. The design is essentially the same fundamental technology with minor dimensional changes to the predicate VERTE-STACK Anatomic PEEK™ Spinal System.

## VIII. Identification of Legally Marketed Devices:

The design features and indications for use for the subject ANATOMIC PEEK™ CERVICAL FUSION SYSTEM are substantially equivalent to predicates:

- . VERTE-STACK Anatomic PEEK™ Spinal System(K070173, SE 3/14/2007)
- CORNERSTONE® PSR Cervical Interbody Fusion Device . (K100214, SE 6/25/2010)
- PEEK PREVAIL™ Cervical Interbody Device (K094042, SE . 6/30/2010)
- Depuy Bengal System (K081917, SE 5/22/2009) .
- Small PLATEAU® (Plateau-C) (K093093, SE 10/13/2010 .

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

The subject ANATOMIC PEEK™ CERVICAL FUSION Devices were tested in accordance ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices", ASTM F2267-04 " Standard Test Method for Measuring Load Induced Subsidence of the Intervertebral Body Fusion Device under Static Axial Compression" and ASTM F-04.25.02.02 "Draft Static Push-out Test Method for Intervertebral Body Fusion Devices". A full list of tests conducted includes:

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## (112444

- Static Compression o
- O Static Compression Shear
- Compression Fatigue o
- O Compression Shear Fatigue
- O Static Torsion
- Torsion Fatigue 0
- O Static Subsidence
- O Static Expulsion

The subject devices met the predetermined acceptance criteria for all tests. Test results were provided to demonstrate that the subject devices are substantially equivalent to the predicate devices.

### X. Conclusion:

A risk analysis was completed and non-clinical performance testing was performed. Based on the test results and additional supporting documentation provided in this pre-market notification, we believe that the subject device demonstrates substantial equivalence to the listed predicate devices.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

NOV 1 5 2011

Medtronic Sofamor Danek, USA Inc. % Ms. Becky Ronner Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K112444

Trade/Device Name: ANATOMIC PEEK™ CERVICAL FUSION SYSTEM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: August 15, 2011 Received: August 24, 2011

Dear Ms. Ronner:

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. Becky Ronner

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 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/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,

forMark 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): _ K112444

Device Name: ANATOMIC PEEK CERVICAL FUSION SYSTEM

### Indications for Use:

The ANATOMIC PEEK CERVICAL FUSION SYSTEM 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 ANATOMIC® PEEK™ device is to be used with supplemental fixation. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach."

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_________________________________________________________________________________________________________________________________________________________________