(87 days)
Not Found
No
The device description and performance studies focus on the mechanical design and structural integrity of a vertebral body replacement system, with no mention of AI or ML capabilities for image processing, diagnosis, or any other function.
No
The device is described as a vertebral body replacement system, replacing resected or excised vertebrae, which serves a structural and supportive role rather than directly curing or alleviating a disease.
No
The device description indicates that the VLIFT-s system is a vertebral body replacement system, which is a therapeutic device intended for spinal fusion, not for diagnosing conditions.
No
The device description clearly describes a physical implant (a distractible vertebral body replacement system) made of materials and with mechanical properties, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant designed to replace a vertebral body or entire vertebra in the spine. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a physical implant made of materials for surgical placement, not reagents, instruments, or software used to analyze biological samples.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used in the body for structural support and replacement.
N/A
Intended Use / Indications for Use
The VLIFT-s system is a device 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 vertebrectorny procedures due to tumor or trauma (i.e., fracture).
For both corpectorny and vertebrectorny procedures, VLIFT -s system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFT -s system include, but are not limited to, Stryker Spine plate or rod systems (e.g., Xia Spinal System, Radius® Spinal System, Mantis® Percutaneous Spinal System, Thore Plating System, Trio +Spinal System). The use of bone graft with VLIFT® -s system is optional.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The VLIFT®-s Distractible In-situ (DIS) Vertebral Body Replacement system is intended for use as an aid in spinal fusion and consists of a single, pre-assembled distractible implant. The hollow cylindrical center may be adjusted continuously via an inner concentric ring. The hollow core of the cage allows for packing bone graft. The use of bone graft with VLIFT®-s is optional. 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
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K060506, K080568, K061891, K003709, K003043
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Stryker Spine VLIFT®-s System
Traditional 510(k) Premarket Notification
SEP 2 5 2009
ー -
510(k) Summary: Stryker Spine VLIFT -s Vertebral Body Replacement System
| Submitter: | Stryker Spine |
|---|---|
| 2 Pearl Court | |
| Allendale, New Jersey 07401 | |
| Contact Person | Ms. Kimberly Lane |
| Regulatory Affairs Specialist | |
| Phone: 201-760-8215 | |
| FAX: 201-760-8415 | |
| Email: Kimberly.lane@stryker.com | |
| Date Prepared | June 26, 2009 |
| Trade Name | Stryker Spine VLIFT®-s Vertebral Body Replacement System |
| Proposed Class | Class II |
| Classification Name | |
| and Number | Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060 |
| Product Code | MQP |
| Predicate Devices | Stryker Spine VLIFT® Vertebral Body Replacement System |
| [K060506], DePuy X-MESHTM Expandable Cage System [K080568], | |
| Synthes Spine Synex TM II Spacer [K061891], | |
| Surgical Dynamics™ Mesh Cage System, [K003709] and | |
| DePuy AcroMed Surgical Titanium Mesh™ [K003043] | |
| Product Code MQP, Class II | |
| Device Description | The VLIFT®-s Distractible In-situ (DIS) Vertebral Body Replacement |
| system is intended for use as an aid in spinal fusion and consists of a | |
| single, pre-assembled distractible implant. The hollow cylindrical | |
| center may be adjusted continuously via an inner concentric ring. The | |
| hollow core of the cage allows for packing bone graft. The use of bone | |
| graft with VLIFT®-s is optional. 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. |
| Intended Use | The VLIFT®-s system is a device 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, VLIFT®-s system |
| | is intended to be used with supplemental internal fixation systems. The |
| | supplemental internal fixation systems that may be used with VLIFT®- |
| | s system include, but are not limited to, Stryker Spine plate or rod |
| | systems (e.g., Xia® Spinal System, Radius® Spinal System, Mantis® |
| | Percutaneous Spinal System, Thor® Plating System, Trio®+Spinal |
| | System). The use of bone graft with VLIFT®-s system is optional. |
| Summary of the | Documentation is provided which demonstrates the Stryker Spine |
| Technological | VLIFT®-s Vertebral Body Replacement System to be substantially |
| Characteristics | equivalent to its predicate devices in terms of its material, design, |
| | indications for use, and mechanical performance. Testing to |
| | demonstrate compliance with FDA's Guidance for Spinal System |
| | 510(k) 's issued May 3, 2004 was completed for the Stryker Spine |
| | VLIFT®-s Vertebral Body Replacement System. |
1
Stryker Spine VLIFT®-s System
1 3
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Stryker Spine % Ms. Kimberly Lane Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
SEP 2 5 2009
Re: K091946
Trade/Device Name: Stryker Spine VLIFT®-s Vertebral Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 26, 2009 Received: June 30, 2009
Dear Ms. Lane:
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 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 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.
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Page 2 - Ms. Kimberly Lane
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 (800) 638-2041 or (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
laubare michm
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Traditional 510(k) Premarket Notification
Stryker Spine VLIFT -s System
Indications for Use
510(k) Number (if known): K C 9 194 G
Device Name: Stryker Spine VLIFT -s Vertebral Body Replacement System
Indications For Use:
The VLIFT -s system is a device 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 vertebrectorny procedures due to tumor or trauma (i.e., fracture).
For both corpectorny and vertebrectorny procedures, VLIFT -s system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFT -s system include, but are not limited to, Stryker Spine plate or rod systems (e.g., Xia Spinal System, Radius® Spinal System, Mantis® Percutaneous Spinal System, Thore Plating System, Trio +Spinal System). The use of bone graft with VLIFT® -s system is optional.
AND/OR Prescription Use_ (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)
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