VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0

K190545 · Icotec AG · NKB · Jun 20, 2019 · Orthopedic

Device Facts

• Record ID: K190545
• Device Name: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
• Applicant: Icotec AG
• Product Code: NKB · Orthopedic
• Decision Date: Jun 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 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 is of insufficient duration to permit achievement of fusion. The VADER® one Pedicle System MIS is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The LightMore® Pedicle System 6.0 is indicated to provide the surgeon with an open approach for posterior spinal surgery.

Device Story

Posterior pedicle screw systems; manufactured from Carbon/PEEK; comprised of polyaxial pedicle screws and rods (curved, straight, J-rods). Used for single or multiple level fixations in non-cervical spine. VADER® one MIS provides minimally invasive approach; LightMore® 6.0 provides open approach. Operated by surgeons in clinical settings. Devices restore spinal column integrity in patients with advanced stage tumors where fusion is not feasible due to limited life expectancy. Benefit: stabilization of spine in palliative oncology patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing including ASTM F543, ASTM F1717, ASTM F1798, and biocompatibility assessment.

Technological Characteristics

Materials: Carbon/PEEK. Components: Polyaxial pedicle screws, curved/straight/J-rods. Standards: ASTM F543 (screw testing), ASTM F1717 (pedicle screw system testing), ASTM F1798 (flexion/torsion). Non-cervical spine fixation. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients with advanced stage tumors of the thoracic and lumbar spine where life expectancy is too short to achieve fusion; intended to restore spinal column integrity without fusion. VADER® one MIS for minimally invasive posterior surgery; LightMore® 6.0 for open posterior surgery.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CarboFix CarboClear Pedicle System (K182377)
• icotec Pedicle System (K151977)
• Blackstone Pedicle Screw System (K082797)
• Corelink Tiger Spine System (K113058)

Reference Devices

• icotec Interbody Cage System (K172480)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 20, 2019

icotec ag % Mr. Justin Eggleton Senior Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001

Re: K190545

Trade/Device Name: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: May 24, 2019 Received: May 28, 2019

Dear Mr. 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 (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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ronald P. Jean, Ph.D. 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

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K190545

#### Device Name

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0

Indications for Use (Describe)

The VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 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 is of insufficient duration to permit achievement of fusion.

The VADER® one Pedicle System MIS is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The LightMore® Pedicle System 6.0 is indicated to provide the surgeon with an 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

| Device Trade Name: | VADER®one Pedicle System MIS and LightMore® Pedicle<br>System 6.0 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | icotec ag<br>Industriestrasse 12<br>9450 Altstätten<br>Switzerland<br>www.icotec-medical.com<br>Phone: [phone] |
| Contact: | Ms. Marina Hess<br>CQO/Management Representative<br>icotec ag |
| Prepared by: | Mr. Justin Eggleton<br>Senior Director, Spine Regulatory Affairs<br>MCRA, LLC<br>1050 K Street NW, Suite 1000<br>Washington, DC 20001<br>[e-mail] |
| Date Prepared: | March 1, 2019 |
| Classifications: | 21 CFR §888.3070, Pedicle screw spinal system |
| Class: | II |
| Product Codes: | NKR |

#### Indications for Use:

The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 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 is of insufficient duration to permit achievement of fusion

The VADER®one Pedicle System MIS is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The LightMore® Pedicle System 6.0 is indicated to provide the surgeon with an open approach for posterior spinal surgery.

{4}------------------------------------------------

# Device Description:

The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0. The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight and J-rods. The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 can be used for single or multiple level fixations in the non-cervical spine.

# Primary Predicate Device:

The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are substantially equivalent to the CarboFix CarboClear Pedicle System (K182377).

## Additional Predicate Devices:

The VADER one Pedicle System MIS and LightMore® Pedicle System 6.0 are substantially equivalent to additional predicate devices:

- icotec Pedicle System (K151977)
- Blackstone Pedicle Screw System (K082797)
- Corelink Tiger Spine System (K113058)

## Reference Device:

The subject 510(k) references the icotec Interbody Cage System (K172480) since it has the same BlackArmor® material, surface coating (Ti-iT®), and the device is used in the same anatomical area.

#### Performance Testing Summary:

The testing of the VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0includes:

- ASTM F543 Screw Testing ●
- ASTM F1717 Pedicle Screw System Testing ●
- ASTM F1798 Flexion Bending and Torsional Gripping ●
- Biocompatibility Assessment ●
- Clinical Data

# Substantial Equivalence:

The subject devices were demonstrated to be substantially equivalent to predicates cited in the table above with respect to indications, design, materials, function, manufacturing, and performance. The non-clinical tests performed by the company include static and dynamic compression per ASTM F1717 and screw testing per ASTM F543 and ASTM F1798. The results of the performed tests demonstrate that the VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are substantially equivalent to legally marketed predicate devices.

{5}------------------------------------------------

## Conclusion:

The purpose of the traditional 510(k) is to receive regulatory clearance to introduce the VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 to interstate commerce. Substantial equivalence has been demonstrated to the cited predicate devices.