VU APOD INTERVERTEBRAL BODY FUSION DEVICE

K101310 · Theken Spine, LLC · OVD · Sep 2, 2010 · Orthopedic

Device Facts

• Record ID: K101310
• Device Name: VU APOD INTERVERTEBRAL BODY FUSION DEVICE
• Applicant: Theken Spine, LLC
• Product Code: OVD · Orthopedic
• Decision Date: Sep 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used with the bone screws, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System. The Theken Spine Vu aPOD Intervertebral Body Fusion Device, when used with bone screws, is a stand alone device. If the Theken Spine Vu aPod Intervertebral Body Fusion Device is used with the SpinPlate then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. The SpinPlate and bone screws are not intended to be used together. This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

Device Story

Lumbar intervertebral body fusion device; consists of PEEK OPTIMA LT1 polymer spacers and Titanium alloy (Ti-6Al-4V ELI) bone screws or SpinPlate; includes tantalum radiographic markers. Implanted by surgeons in clinical settings to facilitate spinal fusion in DDD patients. Used with autogenous bone graft. When used with bone screws, functions as stand-alone device; when used with SpinPlate, requires additional cleared supplemental fixation. Provides structural support to intervertebral space; promotes fusion; stabilizes spinal segment. Benefits patients by addressing discogenic back pain.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified via mechanical testing per ASTM F2077 and ASTM F2267 standards.

Technological Characteristics

Spacer: PEEK OPTIMA LT1 (ASTM F2026). Screws/SpinPlate: Titanium alloy Ti-6Al-4V ELI (ASTM F136). Markers: Tantalum (ASTM F560). Mechanical fixation via screws or plate. Lumbar interbody application.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade 1 spondylolisthesis, who have failed at least 6 months of 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

• Theken Spine Vu aPOD System (K080822)
• Titan Spine Endoskeleton TA (K080615)
• Spinal Elements Lucent Magnum + (K083475)
• I.DR Spine ROI-A (K082262)

Reference Devices

• Coral Spinal System
• BodyForm Thoracolumbar Fixation System

Submission Summary (Full Text)

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# 510(k) Summary

| Manufacturer: | Theken Spine, LLC | SEP 02 2010 | |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|
| | 1800 Triplett Blvd<br>Akron, OH 44306 | 14101310 | |
| Device Trade Name: | Theken Spine Vu aPOD 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: | August 5, 2010 | | |
| Classification: | §888.3080, Intervertebral body fusion device | | |
| Class: | II | | |
| Product Code: | MAX | | |

# Indications For Use:

When used with the bone screws, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material.

When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.

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The Theken Spine Vu aPOD Intervertebral Body Fusion Device, when used with bone screws, is a stand alone device. If the Theken Spine Vu aPod Intervertebral Body Fusion Device is used with the SpinPlate then additional supplemental fixation, which has been cleared by the FIDA for use in the lumbar spine, must be used to augment stability. The SpinPlate and bone screws are not intended to be used together. This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

## Device Description:

The Vu aPOD Intervertebral Body Fusion Device consists of lumbar spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu aPOD spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026 while the bone screws and SpinMate are comprised of Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu aPOD Intervertebral Body Fusion Device is for lumbar spinal use at one or two contiguous levels from the L2-L3 to L5-S1 disc levels.

# Predicate Device(s):

The Vu aPOD Intervertebral Body Fusion Device was shown to be substantially equivalent to previously cleared devices, including the Theken Spine Vu aPOD System (K080822), Titan Spine Endoskeleton TA (K080615), Spinal Elements Lucent Magnum + (K083475), and I.DR Spine ROI-A (K082262), and has the same indications for use, design, and function.

#### Performance Standards:

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

# Conclusion:

Sufficient information, including extensive testing, has been presented to demonstrate the Vu aPOD 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 consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

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

SEP 12 2011

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

Re: K101310

Trade/Device Name: Vu a·POD Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: August 12, 2010 Received: August 13, 2010

Dear Mr. Stiegman:

This letter corrects our substantially equivalent letter of September 2, 2010.

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

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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, by ont rot 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 photifics: " now (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. Millbern

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

SEP 02 2010

### 510(k) Number (if known): K101310

#### Vu aPOD Intervertebral Body Fusion Device Device Name:_

Indications For Use:

When used with the bone screws, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material.

When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.

The Theken Spine Vu aPOD Intervertebral Body Fusion Device, when used with bone screws, is a stand alone device. If the Theken Spine Vu aPod Intervertebral Body Fusion Device is used with the SpinPlate then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. The SpinPlate and bone screws are not intended to be used together. This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Surgical. Orthopedic. and Restorative Devices

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KIDI310 510(k) Number_