(66 days)
No
The device description and intended use focus on the mechanical properties and design of a vertebral body replacement system. There is no mention of AI or ML in the provided text, and the performance studies rely on equivalence to existing devices rather than algorithmic performance metrics.
Yes
The device is described as a vertebral body replacement system, indicated for use in the spine due to conditions like tumor, osteomyelitis, trauma, or degenerative disorders, and is intended to restore the integrity of the spinal column and aid in spinal fusion. These are direct therapeutic interventions.
No
The VLIFT®-s Vertebral Body Replacement System is an implantable device used for replacing diseased or damaged vertebral bodies, primarily to restore spinal integrity and aid in spinal fusion. It is a therapy device, not a diagnostic one.
No
The device description clearly details a physical implant made of materials, with various sizes, shapes, and modular components, intended for surgical implantation. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the VLIFT®-s Vertebral Body Replacement System is a physical implant used to replace or reconstruct vertebral bodies in the spine. It is a surgical device, not a diagnostic test.
- Lack of Diagnostic Information: The text does not mention any analysis of biological samples, detection of biomarkers, or any other activity related to diagnosing a condition.
Therefore, the VLIFT®-s Vertebral Body Replacement System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
VLIFT®-s Vertebral Body Replacement System is indicated for use in the cervical spine (C3-C7) and the thoracolumbar spine (T1-L5) in skeletally mature patial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissue in degenerative disorders.
The VLIFT®-s Vertebral Body Replacement System is intended for use with autograft oone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral Body Replacement System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The VLIFT®-s Vertebral Body Replacement System is intended to be used with FDA-cleared spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
Product codes
PLR, MQP
Device Description
The VLIFT®-s Vertebral Body Replacement System is intended for use as an aid in spinal fusion and consists of a single, pre-assembled distractible implant. The device may be distracted continuously via an inner concentric ring. The hollow core of the cage allows for packing bone graft. As the implant is distracted via its inner concentric ring, additional slotted openings appear.
The VLIFT®-s cages are available in various diameters and heights.
Modular end caps snap into each end of the VLIFT®-s implant. Serrated teeth at the rim of the end cap attachments help to anchor the implant to the end plates of the vertebral bodies. The VLIFT®-s end caps are available in both flush and contoured designs and are offered in a variety of angles.
Extension pieces are available for each diameter for the VLIFT®-s implants. Extension pieces may be used to achieve the desired height. The use of extension pieces is optional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C3-C7) and the thoracolumbar spine (T1-L5)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The published clinical literature demonstrates the substantial equivalence of VLIFT®-s Vertebral Body Replacement to other legally marketed cervical vertebral body replacement devices. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed.
The subject VLIFT®-s Vertebral Body Replacement System and the predicate was shown to be substantially equivalent based on material, design, and mechanical performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K172032, K180673, K162315, K152568, K151651, K091946, K060416
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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January 10, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
Stryker Spine Renee Norby Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K183071
Trade/Device Name: VLIFT®-s Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR, MQP Dated: December 14, 2018 Received: December 17, 2018
Dear Ms. Norby:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
VLIFT®-s Vertebral Body Replacement System
Indications for Use (Describe)
VLIFT®-s Vertebral Body Replacement System is indicated for use in the cervical spine (C3-C7) and the thoracolumbar spine (T1-L5) in skeletally mature patial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissue in degenerative disorders.
The VLIFT®-s Vertebral Body Replacement System is intended for use with autograft oone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral Body Replacement System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The VLIFT®-s Vertebral Body Replacement System is intended to be used with FDA-cleared spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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stryker
510(k) Summary
| 510(k) Summary: VLIFT®-s Vertebral Body Replacement System | |
|---|---|
| Submitter: | Stryker Spine |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Contact Person : | Name: Renee Norby |
| Phone: 201-749-8074 | |
| Email: renee.norby@stryker.com | |
| Date Prepared: | January 7, 2019 |
| Trade Name: | VLIFT®-s Vertebral Body Replacement System |
| Common Name: | Spinal Vertebral Body Replacement Device |
| Proposed Class: | Class II |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) |
| Product Code: | PLR, MQP |
| Predicate Devices: | The VLIFT®-s Vertebral Body Replacement System was shown to be |
| substantially equivalent to the device listed below: |
Primary Predicate:
Aesculap® Implant Systems, Inc., Modulift Vertebral Body Replacement (VBR) System, K172032 Additional Predicates: Zavation Normandy VBR System, K180673Globus Medical Inc., FORTIFY® Corpectomy Spacers, K162315Cardinal Spine, LLC, C-VBR, K152568NuVasive® Incorporated, NuVasive® X-Core® Mini Cervical Expandable VBR System, K151651Stryker Spine, VLIFT®-s Vertebral Body Replacement System, K091946Ulrich GmbH, Obelisc VBR, K060416 Reference Devices: Stryker Spine, AVS® AS PEEK Spacer, K120486Stryker Spine, Tritanium® C Anterior Cervical Cage, K171496 |
| Device Description: | The VLIFT®-s Vertebral Body Replacement System is intended for use as an aid
in spinal fusion and consists of a single, pre-assembled distractible implant. The
device may be distracted continuously via an inner concentric ring. The hollow
core of the cage allows for packing bone graft. As the implant is distracted via
its inner concentric ring, additional slotted openings appear. |
| | 510(k) Summary: VLIFT®-s Vertebral Body Replacement System |
| | The VLIFT®-s cages are available in various diameters and heights. |
| | Modular end caps snap into each end of the VLIFT®-s implant. Serrated teeth at
the rim of the end cap attachments help to anchor the implant to the end plates
of the vertebral bodies. The VLIFT®-s end caps are available in both flush and
contoured designs and are offered in a variety of angles. |
| | Extension pieces are available for each diameter for the VLIFT®-s implants.
Extension pieces may be used to achieve the desired height. The use of
extension pieces is optional. |
| Intended Use: | The Stryker Spine VLIFT®-s Vertebral Body Replacement System is indicated
for use in the cervical spine (C3-C7) and the thoracolumbar spine (T1-L5) in
skeletally mature patients for partial or total replacement of a diseased,
collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis,
trauma (i.e., fracture), or for reconstruction following corpectomy performed to
achieve decompression of the spinal cord and neural tissue in degenerative
disorders. |
| | The VLIFT®-s Vertebral Body Replacement System is intended for use with
autograft or allogenic bone graft comprised of cancellous and/or
corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral
Body Replacement System is also intended to restore the integrity of the spinal
column even in the absence of fusion for a limited time period in patients with
advanced stage tumors involving the cervical, thoracic, and lumbar spine in
whom life expectancy is of insufficient duration to permit achievement of
fusion, with bone graft used at the surgeon's discretion. |
| | The VLIFT®-s Vertebral Body Replacement System is intended to be used with
FDA-cleared supplemental spinal fixation systems that have been labeled for
use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod
systems, anterior plate systems, and anterior screw and rod systems). When
used at more than two levels, supplemental fixation should include posterior
fixation. |
| Summary of the
Technological
Characteristics | The subject VLIFT®-s Vertebral Body Replacement System and the predicate
was shown to be substantially equivalent based on material, design, and
mechanical performance. |
| | The purpose of this 510(k) submission is to seek clearance for use in the
cervical spine. No changes have been made to the actual implants. |
| 510(k) Summary: VLIFT®-s Vertebral Body Replacement System | |
| Summary of the
Performance Data | The published clinical literature demonstrates the substantial equivalence of
VLIFT®-s Vertebral Body Replacement to other legally marketed cervical
vertebral body replacement devices. No changes were made to the existing
devices, nor were any new components added to the system. Therefore, no
additional testing was required or performed. |
| Conclusion | The design features, materials used, manufacturing, and sterilization methods
are identical to the previously cleared VLIFT®-s Vertebral Body Replacement
System with the exception of broadening the indications to include the cervical
spine. Additionally, the design features, materials used, manufacturing, and
sterilization methods are similar to the predicates identified in this submission.
Based on information provided, the subject device has been determined to be
substantially equivalent to the predicate devices. |
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stryker
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