VU C*POD INTERVERTEBRAL BODY FUSION DEVICE

K111675 · Theken Spine, LLC · ODP · Aug 2, 2011 · Orthopedic

Device Facts

• Record ID: K111675
• Device Name: VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
• Applicant: Theken Spine, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Aug 2, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vu c POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Vu c.POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Theken Spine Manta Ray or the Theken Spine Tether systems.

Device Story

The Vu c-POD is a cervical spinal interbody fusion implant designed for single-level anterior fusion. It is manufactured from PEEK OPTIMA LT1 polymer. The device is implanted by a surgeon via an open, anterior approach to the cervical spine. It functions as a spacer to facilitate fusion, requiring the addition of autogenous bone graft and the use of supplemental internal fixation systems (e.g., Manta Ray or Tether systems) to provide stability. The device benefits patients with discogenic neck pain by promoting intervertebral fusion.

Clinical Evidence

Bench testing only. Preclinical mechanical testing was performed per ASTM F2077 and ASTM F2267 to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Material: PEEK OPTIMA LT1 polymer. Form factor: Cervical interbody fusion implant. Mechanical testing standards: ASTM F2077, ASTM F2267. Requires supplemental internal fixation and autogenous bone graft.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) at one level (C2-C3 to C7-T1) who have failed six weeks of non-operative treatment. Requires use with autogenous bone graft and supplemental internal fixation.

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

• Vu c.POD Intervertebral Body Fusion Device (K101363)

Reference Devices

• Theken Spine Manta Ray system
• Theken Spine Tether system

Submission Summary (Full Text)

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| Integra Spine | Vu c-POD™ IBF Device | 6/7/2011 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| 510(k) Summary | AUG - 2 2011 | |
| Manufacturer: | Integra Spine<br>1153 Medina Road<br>Medina, OH 44256 | |
| Device Trade Name: | Vu c-POD Intervertebral Body Fusion Device | |
| Contact: | Dale Davison<br>Vice President, Engineering<br>Integra Spine<br>1153 Medina Road<br>Medina, OH 44256<br>Office: 330.239.7700<br>Fax: [phone] | |
| Classification: | §888.3080 | |
| Class: | II | |
| Product Code: | ODP | |

## Indications For Use:

The Vu c POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Vu c.POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Theken Spine Manta Ray or the Theken Spine Tether systems.

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### Integra Spine

### Vu c·POD™ IBF Device

6/7/2011

#### Device Description:

The Vu c POD Intervertebral Body Fusion Device consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu c POD Intervertebral Body Fusion Device is manufactured from PEEK OPTIMA LT1 polymer. The Vu c·POD Intervertebral Body Fusion Device is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.

## Predicate Device(s):

The Vu c·POD Intervertebral Body Fusion Device was shown to be substantially equivalent to the previously cleared Vu c.POD Intervertebral Body Fusion Device, K101363, SE 12/16/2010 and has the same indications for use, design, and function.

### Performance Standards:

Preclinical testing has been performed per ASTM F2077 and ASTM F2267 indicating that the Vu c POD Intervertebral Body Fusion Device is substantially equivalent to the predicate device.

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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 eagle or bird-like figure with three wing-like lines, positioned to the right of a circular border. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

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

Integra Spine % Mr. Dale Davison Vice President, Engineering 1153 Medina Road Medina, Ohio 44256

AUG - 2 2011

Re: K111675

Trade/Device Name: Theken Spine Vu c-POD Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 18, 2011 Received: July 19, 2011

Dear Mr. Davison:

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 - Mr. Dale Davison

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/CDRH/CDRHOffices/ucm115809.html 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 vours

Sincerely yours,

Mark M Milkman

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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Integra Spine

510(k) Number (if known): Kul675

# Device Name: Theken Spine Vu c·POD Intervertebral Body Fusion Device

:

The Vu c-POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Vu c POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Theken Spine Manta Ray or the Theken Spine Tether systems.

Prescription Use V (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (29 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

_
(Division Sign-Off)

(Division Sign Qily Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________ KIJ1673

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