VU CPOD INTERVERTEBRAL BODU FUSION DEVICE

K101363 · Musculoskeletal Clinical Regulatory Advisers · ODP · Dec 16, 2010 · Orthopedic

Device Facts

• Record ID: K101363
• Device Name: VU CPOD INTERVERTEBRAL BODU FUSION DEVICE
• Applicant: Musculoskeletal Clinical Regulatory Advisers
• Product Code: ODP · Orthopedic
• Decision Date: Dec 16, 2010
• Decision: SESE
• Submission Type: Traditional
• 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 nonoperative treatment. The Vu c POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Theken Manta Ray or the Theken Tether systems.

Device Story

Vu c·POD Intervertebral Body Fusion Device is a cervical spinal implant; used for anterior interbody fusion at one level (C2-C3 to C7-T1). Device consists of PEEK OPTIMA LT1 polymer spacers with tantalum radiographic markers; implanted via open anterior approach; requires autogenous bone graft; must be used with supplemental internal fixation (e.g., Manta Ray or Tether systems). Intended for skeletally mature patients with cervical DDD. Device provides structural support to facilitate fusion; surgeon-operated in clinical/OR setting.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F2077 (static/dynamic axial compression, compression-shear, torsion, expulsion) and ASTM F2267 (static subsidence). No clinical data presented.

Technological Characteristics

Spacer material: PEEK OPTIMA LT1 (ASTM F2026). Radiographic markers: Tantalum (ASTM F560). Form factor: Cervical interbody fusion spacer. Energy source: None (mechanical). Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) at one level (C2-C3 to C7-T1) presenting with discogenic neck pain confirmed by radiography, following six weeks of failed nonoperative 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

• US Spine Phantom PLUS Cage System (K082801)
• Interbody Innovations Zeus Cervical Cage (K081614)
• LDR Spine MC+ (K080588)
• LDR Spine ROI-C Cervical Cage (K091088)
• Synthes Spine Zero-P Cervical Cage (K072981)
• SpineArt Tryptik® Cervical Cage (K091873)

Submission Summary (Full Text)

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# KIO13G3

### DEC 1 6 2010

## 510(k) Summary

| Manufacturer: | Theken Spine, LLC<br>1800 Triplett Blvd<br>Akron, OH 44306 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Theken Spine Vu c•POD Intervertebral Body Fusion Device |
| Contact: | Glenn Stiegman<br>Vice President, Regulatory Affairs<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>Office: 202.552.5800<br>Fax: [phone] |
| Date Prepared: | November 24, 2010 |
| Classification: | §888.3080, Intervertebral body fusion device |
| 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 nonoperative treatment. The Vu c POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Theken Manta Ray or the Theken Tether systems.

#### 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 spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu c POD Intervertebral Body Fusion Device is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.

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K101363

#### Predicate Device(s):

The Vu c POD Intervertebral Body Fusion Device was shown to be substantially equivalent to previously cleared devices, including the US Spine Phantom PLUS Cage System (K082801), Interbody Innovations Zeus Cervical Cage (K081614), LDR Spine MC+ (K080588), LDR Spine ROI-C Cervical Cage (K091088), Synthes Spine Zero-P Cervical Cage (K072981), and SpineArt Tryptik® Cervical Cage (K091873).

#### Summary of Technological Characteristics:

The Vu c POD Intervertebral Body Fusion Device, in comparison to relevant predicate devices, has been shown to have the same indications for use, design, material of manufacture, and function.

#### Performance Standards:

Preclinical testing has been performed per ASTM F2077 (static axial compression, static compression-shear, static torsion, dynamic axial compression, dynamic compression-shear, expulsion) and ASTM F2267 (static subsidence) indicating that the Vu crPOD Intervertebral Body Fusion Device is substantially equivalent to predicate devices.

#### Conclusion:

Sufficient information, including extensive testing, has been presented to demonstrate the Vu c POD Intervertebral Body Fusion Device is substantially equivalent to predicate devices with the same indications, intended use, and technological features.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.

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

Theken Spine, LLC % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Glenn Stiegman Vice President, Regulatory Affairs 1331 H Street NW, 12th Floor Washington, District of Columbia 20005

DEC 1 6 2010

Re: K101363

1

Trade/Device Name: 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: December 02, 2010 Received: December 03, 2010

Dear Mr. Stiegman:

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. Glenn Stiegman

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/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. Milkus

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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## Indications for Use

510(k) Number (if known): K101363

#### Device Name: Integra Spine Vu coPOD 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 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 nonoperative treatment. The Vu c POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Integra Spine Manta Ray or the Integra Spine Tether systems.

V Prescription Use (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)

Mark A. Millhusan

Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K10/363