(87 days)
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.
Stryker Spine VLIFT™ is a vertebral body replacement system, intended for use as an aid in spinal fusion.
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.
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.
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.
I'm sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is primarily a 510(k) summary for the Stryker Spine VLIFT™ Vertebral Body Replacement System, detailing its description, intended use, and substantial equivalence to predicate devices. It mentions "Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed," but it does not describe the specific tests, acceptance criteria, or performance results from such a study.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample size, data provenance, ground truth, expert involvement, or MRMC studies.
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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 Spine2 Pearl CourtAllendale, New Jersey 07401 |
|---|---|
| Contact Person | Ms. Simona VoicRegulatory Affairs Project ManagerPhone: 201-760-8145FAX: 201-760-8345Email: simona.voic@stryker.com |
| Date Prepared | May 15, 2006 |
| Trade Name | Stryker Spine VLIFT™ Vertebral Body Replacement System |
| Proposed Class | Class II |
| Classification Nameand Number | Spinal Intervertebral Body Fixation Orthosis21 CFR 888.3060 |
| Product Code | MQP |
| Predicate Devices | 1) Stryker Spine AVS™ PL Peek Spacer (K050624),Product Code MQP, Class II2) Synthes Spine Synex™ Spacer System (K003836),Product Code MQP, Class II3) Surgical Dynamics Mesh Cage System (K003709),Product Code MQP, Class II4) 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.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.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.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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| K060506Stryker Spine VLIFTTM System | |
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| Page 2 of 2 | |
| Intended Use | Stryker Spine VLIFTTM is a vertebral body replacement systemintended to replace a vertebral body or an entire vertebra. It is foruse in the thoracolumbar spine (T1-L5) to replace a collapsed,damaged, or unstable vertebral body or vertebra resected orexcised during total and partial corpectomy and vertebrectomyprocedures due to tumor or trauma (i.e., fracture). For bothcorpectomy and vertebrectomy procedures, the VLIFTTM systemis intended to be used with supplemental internal fixationsystems. The supplemental internal fixation systems that may beused with VLIFTTM include, but are not limited to Stryker Spineplate or rod systems (Xia® Spinal System, Spiral Radius 90D,and Trio). The use of bone graft with VLIFTTM is optional. |
| Summary of theTechnologicalCharacteristics | Documentation is provided which demonstrates the StrykerSpine VLIFTTM Vertebral Body Replacement System to besubstantially equivalent to its predicate devices in terms of itsmaterial, design, indications for use, and mechanicalperformance. Testing to demonstrate compliance with FDA'sGuidance for Spinal System 510(k)'s May 3, 2004 wascompleted for the Stryker Spine VLIFTTM Vertebral BodyReplacement 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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):
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
Page 1 of
510(k) Number K060506
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
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.(b)
Classification. Class II.