STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM

K060506 · Stryker Spine · MQP · May 25, 2006 · Orthopedic

Device Facts

• Record ID: K060506
• Device Name: STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
• Applicant: Stryker Spine
• Product Code: MQP · Orthopedic
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stryker Spine VLIFT™ is a vertebral body replacement system intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectomy procedures due to tumor or trauma (i.e., fracture). For both corpectomy and vertebrectomy procedures, the VLIFT™ system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFT™ include, but are not limited to Stryker Spine plate or rod systems (Xia® Spinal System, Spiral Radius 90D, and Trio). The use of bone graft with VLIFT™ is optional.

Device Story

Stryker Spine VLIFT™ is a vertebral body replacement system; consists of a pre-assembled, cylindrically shaped titanium cage with a distractible/retractable center. Hollow core allows for optional bone graft packing. Available in 18mm and 22mm diameters; heights range from 18.5mm to 58.5mm; optional extension pieces add 15mm each (max height 88.5mm). End caps feature various round angled shapes to match sagittal spinal segment angles. Used in thoracolumbar spine (T1-L5) procedures; requires supplemental internal fixation (e.g., Stryker Xia, Spiral Radius 90D, Trio). Intended for use by surgeons in clinical settings to replace collapsed, damaged, or unstable vertebrae. Provides structural support to the spinal column following resection or excision.

Clinical Evidence

Bench testing only; no clinical data provided. Compliance with FDA's Guidance for Spinal System 510(k)s (May 3, 2004) demonstrated through mechanical performance testing.

Technological Characteristics

Material: Titanium. Design: Cylindrical, distractible/retractable cage with hollow core for bone graft. Dimensions: 18mm/22mm diameters; 18.5-58.5mm height (up to 88.5mm with extensions). End caps: Round angled shapes. Connectivity: None. Energy source: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) following corpectomy or vertebrectomy due to tumor or trauma (fracture). Must be used with supplemental internal fixation.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Stryker Spine AVS™ PL Peek Spacer (K050624)
• Synthes Spine Synex™ Spacer System (K003836)
• Surgical Dynamics Mesh Cage System (K003709)
• DePuy Harms Mesh Cage (K003043)

Submission Summary (Full Text)

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K060506 Stryker Spine VLIFT™ System Page 1 of 2

## MAY 2 5 2006

## 510(k) Summary of Safety and effectiveness Stryker Spine VLIFT™ Vertebral Body Replacement System

| Submitter: | Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Simona Voic<br>Regulatory Affairs Project Manager<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Date Prepared | May 15, 2006 |
| Trade Name | Stryker Spine VLIFT™ Vertebral Body Replacement System |
| Proposed Class | Class II |
| Classification Name<br>and Number | Spinal Intervertebral Body Fixation Orthosis<br>21 CFR 888.3060 |
| Product Code | MQP |
| Predicate Devices | 1) Stryker Spine AVS™ PL Peek Spacer (K050624),<br>Product Code MQP, Class II<br>2) Synthes Spine Synex™ Spacer System (K003836),<br>Product Code MQP, Class II<br>3) Surgical Dynamics Mesh Cage System (K003709),<br>Product Code MQP, Class II<br>4) DePuy Harms Mesh Cage (K003043), Product Code MQP, Class II |
| Device Description | Stryker Spine VLIFT™ is a vertebral body replacement system, intended for use as an aid in spinal fusion.<br><br>The VLIFT™ vertebral body replacement system consists of a single, pre-assembled cylindrically shaped titanium cage, with a distractible or retractable center. The hollow core of the cage allows for packing bone graft. The use of bone graft with VLIFT™ is optional.<br><br>The VLIFT™ cages are available in two (2) diameters (18 mm and 22 mm) and cover a range of heights from 18.5 to 58.5 mm. The end caps are available in a variety of round angled shapes to better match the sagittal angle of the spinal segment.<br><br>The optional extension pieces are offered for both the 18mm and 22mm diameter cages. Each extension piece adds 15mm to the construct height. One or two extensions can be assembled to the implant, which creates a maximum construct height of 88.5 mm. |

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| age | €<br>ﮯ | of 2 | |
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| | K060506<br>Stryker Spine VLIFTTM System |
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| | Page 2 of 2 |
| Intended Use | Stryker Spine VLIFTTM is a vertebral body replacement system<br>intended to replace a vertebral body or an entire vertebra. It is for<br>use in the thoracolumbar spine (T1-L5) to replace a collapsed,<br>damaged, or unstable vertebral body or vertebra resected or<br>excised during total and partial corpectomy and vertebrectomy<br>procedures due to tumor or trauma (i.e., fracture). For both<br>corpectomy and vertebrectomy procedures, the VLIFTTM system<br>is intended to be used with supplemental internal fixation<br>systems. The supplemental internal fixation systems that may be<br>used with VLIFTTM include, but are not limited to Stryker Spine<br>plate or rod systems (Xia® Spinal System, Spiral Radius 90D,<br>and Trio). The use of bone graft with VLIFTTM is optional. |
| Summary of the<br>Technological<br>Characteristics | Documentation is provided which demonstrates the Stryker<br>Spine VLIFTTM Vertebral Body Replacement System to be<br>substantially equivalent to its predicate devices in terms of its<br>material, design, indications for use, and mechanical<br>performance. Testing to demonstrate compliance with FDA's<br>Guidance for Spinal System 510(k)'s May 3, 2004 was<br>completed for the Stryker Spine VLIFTTM Vertebral Body<br>Replacement System. |

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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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three wavy lines forming the head, body, and legs.

Public Health Service

MAY 2 5 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Spine c/o Ms. Simona Voic 2 Pearl Court : … … Allendale, New Jersey 07401

Re: K060506

Trade Name: VLIFTTM Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 2, 2006 Received: May 3, 2006

Dear Ms. Voic:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Simona Voic

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 limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Hekut Lemer aos

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Stryker Spine VLIFT™ System Page 1 of 1

## Indications for Use

510(k) Number (if known):

K060506

Device Name:

Stryker Spine VLIFT™ Vertebral Body Replacement System

Indications For Use:

Stryker Spine VLIFT™ is a vertebral body replacement system intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra resected or excised during total and partial corpectorny and vertebrectorny procedures due to tumor or trauma (i.e., fracture). For both corpectorny and vertebrectomy procedures, the VLIFT™ system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFT™ include, but are not limited to Stryker Spine plate or rod systems (Xia Spinal System, Spiral Radius 90D, and Trio). The use of bone graft with VLIFT™ is optional.

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)

Hukum Remevas

Division of General, Restoral and Neurological Devices

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510(k) Number K060506