(157 days)
No
The device description and intended use focus on mechanical components for spinal stabilization and do not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes
The VADER® Pedicle System is intended to restore the integrity of the spinal column, stabilize the thoracic and/or lumbar spine, and provide an adjunct to fusion, all of which are direct actions to treat a physical condition, defining it as a therapeutic device.
No
The VADER® Pedicle System is described as a surgical implant (pedicle screws, rods, connectors) intended to restore integrity and stabilize the spinal column. Its stated purpose is treatment (restoring integrity, stabilization, adjunct to fusion), not diagnosis.
No
The device description explicitly lists physical components made from Carbon/PEEK, such as pedicle screws, rods, and connectors, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to stabilize the spine in patients with specific conditions (tumors, infection). This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a system of screws, rods, and connectors made from Carbon/PEEK, intended for surgical implantation. This aligns with a surgical device, not a device used to examine specimens from the human body.
- No mention of in vitro testing: There is no mention of the device being used to test samples (blood, tissue, etc.) outside of the body.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
The VADER® Pedicle System:
The VADER® Pedicle System is 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.
When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws are 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
The VADER® Pedicle System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.
The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.
VADER®one Pedicle System:
The VADER ®one Pedicle System is 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.
The VADER®one Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.
Product codes
NKB, PML
Device Description
The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System and VADER®one Pedicle System with additional connector components. The VADER® Pedicle System and VADER®one Pedicle System are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of:
- Polyaxial cannulated, fenestrated pedicle screws,
- Polyaxial, cannulated, pedicle screws, ●
- Curved. straight. S-rods. J-rods. ●
- Connectors .
The VADER® Pedicle System and VADER®one Pedicle System can be used for single or multiple level fixations in the non-cervical spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracic and lumbar spine, non-cervical spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, posterior spinal surgery
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)
Bench testing consisting of static axial gripping capacity testing and static torque gripping capacity per ASTM 1798 and dynamic compression bending per ASTM F1717 was successfully completed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VADER® Pedicle System (K232628), VADER®one Pedicle System MIS (K193423), Tiger® Spine System (K133369)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
February 27, 2025
Image /page/0/Picture/1 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
icotec ag % Justin Eggleton VP. Musculoskeletal Regulatory Affairs MRCA, LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K242900
Trade/Device Name: VADER® Pedicle System and VADER®one Pedicle System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB. PML Dated: January 17, 2025 Received: January 17, 2025
Dear Justin Eggleton:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Image /page/2/Picture/3 description: The image contains the name "Colin O'neill -S" on the left side of the image. On the right side of the image, there is a faded logo that appears to be "FDA". The text is black, and the logo is a light blue color.
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242900
Device Name VADER® Pedicle System, VADER®one Pedicle System
Indications for Use (Describe)
The VADER® Pedicle System:
The VADER® Pedicle System is 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.
When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws are 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
The VADER® Pedicle System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis) and spinal instability due to infection, surgical debridement, or decompression.
The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.
VADER®one Pedicle System:
The VADER ®one Pedicle System is 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.
The VADER®one Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
510(k) Summary
| Device Trade Name: | VADER® Pedicle System, VADER®one Pedicle System |
|---|---|
| Manufacturer: | icotec ag |
| Industriestrasse 12 | |
| 9450 Altstaetten | |
| Switzerland | |
| www.icotec-medical.com | |
| Contact: | Justin Eggleton |
| Vice President, Head of Musculoskeletal Regulatory Affairs | |
| MCRA, LLC | |
| 803 7th Street, NW, 3rd Floor | |
| Washington, DC 20001 | |
| Phone: 202.552.5804 | |
| jeggleton@mcra.com | |
| Prepared by: | MCRA, LLC |
| 803 7th Street, NW, 3rd Floor | |
| Washington, DC 20001 | |
| Office: 202.552.5800 | |
| Date Prepared: | February 21, 2025 |
| Classifications: | 21 CFR §888.3070, Thoracolumbosacral pedicle screw system |
| 21 CFR §888.3027, Polymethylmethacrylate (PMMA) bone | |
| cement | |
| Class: | II |
| Product Codes: | NKB, PML |
| Primary Predicate: | VADER® Pedicle System (K232628) |
| Additional Predicate: | VADER®one Pedicle System MIS (K193423) |
| Tiger® Spine System (K133369) |
Indications For Use:
The VADER® Pedicle System:
The VADER® Pedicle System is 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.
6
When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws are 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
The VADER® Pedicle System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.
The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.
VADER®one Pedicle System:
The VADER ®one Pedicle System is 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.
The VADER®one Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.
Device Description:
The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System and VADER®one Pedicle System with additional connector components. The VADER® Pedicle System and VADER®one Pedicle System are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of:
- Polyaxial cannulated, fenestrated pedicle screws,
- Polyaxial, cannulated, pedicle screws, ●
- Curved. straight. S-rods. J-rods. ●
- Connectors .
The VADER® Pedicle System and VADER®one Pedicle System can be used for single or multiple level fixations in the non-cervical spine.
7
Predicate Device:
icotec ag submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, VADER® Pedicle System and VADER®one Pedicle System is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices:
Primary Predicate: VADER® Pedicle System (K232628)
Additional Predicate: VADER®one Pedicle System MIS (K193423) Tiger® Spine System (K133369)
Performance Testing Summary:
Bench testing consisting of static axial gripping capacity testing and static torque gripping capacity per ASTM 1798 and dynamic compression bending per ASTM F1717 was successfully completed.
Substantial Equivalence:
The subject device was demonstrated to be substantially equivalent to the predicate cited in the section above with respect to indications, design, materials, function, manufacturing, and performance. The VADER® Pedicle System and the VADER®one Pedicle System are substantially equivalent to the legally marketed predicate device.
Conclusion:
The icotec VADER® Pedicle System and the icotec VADER®one Pedicle System are substantially equivalent to the cited predicate device with respect to indications for use, design, function, material, and performance.