K260989 · Kyocera Medical Technologies Inc. (KMTI) · NKB · May 15, 2026 · Orthopedic
Device Facts
Record ID
K260989
Device Name
Varion Thoracolumbar Fixation System
Applicant
Kyocera Medical Technologies Inc. (KMTI)
Product Code
NKB · Orthopedic
Decision Date
May 15, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3070
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The KMTI Varion Thoracolumbar Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. When used for posterior non-cervical screw fixation in pediatric patients, the Varion Thoracolumbar Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the Varion Thoracolumbar Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft. The KMTI Varion Navigated Instruments System is intended to be used during the preparation and placement of KMTI screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The KMTI Varion Navigated Instruments System is specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Device Story
Varion Thoracolumbar Fixation System comprises longitudinal rods, polyaxial screws, modular tulips, and cross-links for spinal stabilization. Navigated instruments (probes, taps, drivers) integrate with Medtronic StealthStation S8 System for image-guided surgery. Surgeon uses navigation to track instrument position relative to patient anatomy (CT/MR/fluoroscopy) during open or minimally invasive procedures. System provides mechanical fixation to support spinal fusion; navigation assists in precise screw placement. Benefits include improved surgical accuracy and stabilization of spinal segments.
Clinical Evidence
Bench testing only. Performed static/dynamic compression bending (ASTM F1717), static torsion (ASTM F1717), and static axial/torsion grip and tulip-shank disassociation (ASTM F1798). Navigated instruments evaluated via engineering analysis and geometric comparison to Medtronic equivalent instruments.
Technological Characteristics
Implants: Ti-6Al-4V ELI (ASTM F136) or Co-28Cr-6Mo (ASTM F1537). Instruments: medical grade stainless steel and titanium alloy. System includes polyaxial screws, rods, tulips, cross-links. Navigated instruments compatible with Medtronic StealthStation S8. Sterilization: not specified. Mechanical testing per ASTM F1717 and F1798.
Indications for Use
Indicated for skeletally mature patients for posterior, non-cervical fixation as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, spinal curvatures, tumor, pseudarthrosis, or failed fusion. Also indicated for pediatric patients for adolescent idiopathic scoliosis, spondylolisthesis/spondylolysis, and fracture caused by tumor/trauma (posterior approach only, with autograft/allograft). Navigated instruments assist surgeons in locating anatomical structures during spinal 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.
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 15, 2026
Kyocera Medical Technologies Inc. (KMTI)
% Hannah Taggart
Engineer & Regulatory Specialist
Applied Technical Services (Empirical Technologies)
Contact Address
Re: K260989
Trade/Device Name: Varion Thoracolumbar Fixation System
Regulation Number: 21 CFR 888.3070
Regulation Name: Thoracolumbosacral Pedicle Screw System
Regulatory Class: Class II
Product Code: NKB, OLO
Dated: [NOTE: Use date of most recent supplement]
Received: March 27, 2026
Dear Hannah Taggart:
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260989 - Hannah Taggart
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(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K260989 - Hannah Taggart
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Sincerely,
COLIN O'NEILL -S
F-DA
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
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K260989 Page 1 of 1
| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260989 | ? |
| Please provide the device trade name(s). | | ? |
| Varion Thoracolumbar Fixation System | | |
| Please provide your Indications for Use below. | | ? |
| The KMTI Varion Thoracolumbar Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. When used for posterior non-cervical screw fixation in pediatric patients, the Varion Thoracolumbar Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the Varion Thoracolumbar Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft. The KMTI Varion Navigated Instruments System is intended to be used during the preparation and placement of KMTI screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The KMTI Varion Navigated Instruments System is specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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510(K) SUMMARY
#
#
#
KYOCERA
| Submitter's Name: | Kyocera Medical Technologies, Inc. |
| --- | --- |
| Submitter's Address: | 1289 Byrn Mawr Avenue, Suite A Redlands CA, 92374 |
| Submitter's Telephone: | 909-557-2360 |
| Contact Person: | Hannah Taggart, MS, RAC Applied Technical Services (Empirical Technologies) 1-719-4571152 htaggart@atslab.com |
| Date Summary was Prepared: | March 25, 2026 |
| Trade or Proprietary Name: | Varion Thoracolumbar Fixation System |
| Device Classification Name: | Thoracolumbosacral Pedicle Screw System Steretoxic Instrument System |
| Classification & Regulation #: | Class II per 21 CFR §888.3070 21 CFR §882.4560 |
| Product Code: | NKB, OLO |
| Classification Panel: | Orthopedic – Division of Spinal Devices (DHT6B) |
# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Kyocera Medical Technologies, Inc. (KMTI) Varion Thoracolumbar Fixation System is an internal thoracolumbar spinal fixation system comprised of longitudinal rods, polyaxial screws, modular tulips, and cross-links. The implant screw shanks, set screws, and tulips are manufactured from Ti-6Al-4V ELI per ASTM F136. The implant rods are manufactured from either Ti-6Al-4V titanium alloy per ASTM F136 or Co-28Cr-6Mo per ASTM F1537. The Varion Thoracolumbar Fixation System is offered in various sizes and configurations to accommodate patient anatomical needs.
The KMTI Varion Thoracolumbar Fixation System may be used with instruments from the KMTI Varion Navigated Instruments System for navigated preparation and placement of the implants during spinal surgery. The KMTI Varion Navigated Instruments System includes probes, taps, and drivers manufactured from medical grade stainless steel and titanium alloy which are compatible with Medtronic® StealthStation™ S8 System.
# INDICATIONS FOR USE
The KMTI Varion Thoracolumbar Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical screw fixation in pediatric patients, the Varion Thoracolumbar Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the Varion Thoracolumbar Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
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The KMTI Varion Navigated Instruments System is intended to be used during the preparation and placement of KMTI screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The KMTI Varion Navigated Instruments System is specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
## TECHNOLOGICAL CHARACTERISTICS
The predicates included in this submission were selected based on the best practices described in the FDA Draft Guidance document. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use
- Structure and Function
- Size and Styles
- Materials of manufacture
- Sterility
- Manufacturing and biocompatibility
- Mechanical Strength
## Predicate Devices
| 510k Number | Trade Name | Manufacturer | Product Code | Predicate Type |
| --- | --- | --- | --- | --- |
| K210539 | CoreLink Medilne Fixation System | CoreLink, LLC | NKB | Primary |
| K201648 | Safe Orthopeadics | Sterispine™ PS | NKB, KWQ | Additional |
| K223494 | CD Horizon Spinal System | Medtronic | OLO, NKB, KWP, KWQ, HBE | Additional |
There are no differences between the subject and predicate devices which raise questions for the safety and efficacy of the subject devices.
## PERFORMANCE DATA
The Varion Thoracolumbar Fixation System has been tested in the following test modes:
- Static Compression Bending per ASTM F1717
- Dynamic Compression Bending per ASTM F1717
- Static Torsion per ASTM F1717
- Static Axial Grip per ASTM F1798
- Static Torsion Grip per ASTM F1798
- Static Tulip-Shank Disassociation per ASTM F1798
The Varion Navigated Instruments System has been evaluated through an engineering analysis with a geometric comparison and a functional assessment of mating arrays and instrument verification compared to the
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Medtronic equivalent navigated instruments showing equivalent critical geometry. Based upon the equivalency in geometry, performance testing such as positional accuracy per ASTM F2554 was not required.
The results of this non-clinical testing and analysis show that the performance of the Varion Thoracolumbar Fixation System and Varion Navigated Instruments System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
## CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Varion Thoracolumbar Fixation System and Varion Navigated Instruments System are substantially equivalent to the predicate device.
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