PEEK PREVAIL CERVICAL INTERBODY DEVICE

K073285 · Medtronic Sofamor Danek USA, Inc. · OVE · May 15, 2008 · Orthopedic

Device Facts

• Record ID: K073285
• Device Name: PEEK PREVAIL CERVICAL INTERBODY DEVICE
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: May 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PEEK PREVAIL™ Cervical Interbody Device is indicated 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. 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. The PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment.

Device Story

PEEK PREVAIL™ Cervical Interbody Device is an intervertebral body fusion implant; I-beam shape; features internal screw fixation to stabilize vertebral bodies and prevent expulsion. Implanted via open, anterior approach; requires autograft. Components include PEEK Optima, tantalum radiopaque markers, and Nitinol screw locking mechanism. ZEPHIR® Anterior Cervical Screws (titanium alloy) provide fixation. Used by surgeons in clinical settings to treat cervical disc disease; provides structural support for fusion; benefits patients by relieving nerve root or spinal cord compression.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design comparison to predicate devices.

Technological Characteristics

Materials: PEEK Optima, Titanium Alloy (screws), Tantalum (markers), Nitinol (locking mechanism). Form factor: I-beam shaped interbody cage with 2-screw midline configuration. Energy source: None (mechanical). Sterilization: Not specified.

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.

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

• AFFINITY® Anterior Cervical Cage (P000028)
• BAK/C® Cervical Interbody Fusion System (P980048)
• VERTE-STACK® Spinal System (K070173, K062073)
• VENTURE™ Anterior Cervical Plate System (K061274)

Submission Summary (Full Text)

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K073285

## MAY 1 5 2008

## MEDTRONIC Sofamor Danek PEEK PREVAIL™ Cervical Interbody Device February 2008

- 】. Company:
Medtronic Sofamor Danek, Inc. 1800 Pyramid Place Memphis, Tennessee 38132 [phone]

II. PEEK PREVAIL™ Cervical Interbody Device Product Name: Common Name: Interbody Fusion Device 21 CFR 888.3080 - Product Code: MAX ODP Classification:

> III. Description: The PEEK PREVAIL™ Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant is "I-Beam" shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autograft.

The PEEK PREVAIL™ Cervical Interbody device implant is manufactured from PEEK Optima and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR® Anterior Cervical Screws) are manufactured from Titanium Alloy.

- IV. Indications for Use: The PEEK PREVAIL™ Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc discase 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 hemiated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

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- V. Substantial Equivalence: Documentation was provided which demonstrated that the PEEK PREVAIL™ Cervical Interbody Device components are substantially equivalent to previously approved devices such as the previously approved AFFINITY® Anterior Cervical Cage (P000028, Approved - 06/13/2002), the BAK/C® Cervical Interbody Fusion System (P980048, Approved – 04/20/2001), VERTE-STACK® Spinal System (K070173, S.E. 3-14-2007 and K062073, S.E. 8-14-2007), and the VENTURE™ Anterior Cervical Plate System (K061274, S.E. 05-25-2006).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Medtronic Sofamor Danek, Inc. % Mr. Michael Scott 1800 Pyramid Place Memphis, TN 38132

SEP 12 2011

Re: K073285

> Trade/Device Name: PEEK PREVAIL™ Cervical Interbody Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: May 7, 2008 Received: May 9, 2008

Dear Mr. Scott:

This letter corrects our substantially equivalent letter of May 15, 2008.

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 (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

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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,
Mark A. Milkerss

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): KO73285

Device Name: PEEK PREVAIL™ Cervical Interbody Device

Indications for Usc:

The PEEK PREVAIL™ Cervical Interbody Device is indicated 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. 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. The PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment.

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

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)

Nil R.P.Ogl. for mkm

. Restorative. Division of General and Neurological Devices

510(k) Number K073285