FRAXION Spinal Fixation System

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 17, 2026 Ortler Global Tibbi Gerecler Anonim Sirketi Victor Weaver Regulatory Consultant Ivedikkoy Mah., 1492 Cadde, 17 B, 43, Yenimahalle Ankara, 06378 Turkey Re: K262091 Trade/Device Name: FRAXION Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: June 22, 2026 Received: June 22, 2026 Dear Victor Weaver: 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 {1} K262091 - Victor Weaver Page 2 (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). {2} K262091 - Victor Weaver Page 3 Sincerely,  For 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 | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262091 | ? | | Please provide the device trade name(s). | | ? | | FRAXION Spinal Fixation System | | | | Please provide your Indications for Use below. | | ? | | FRAXION SPINAL FIXATION SYSTEM is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the FRAXION SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: * Degenerative disc disease (DDD), defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; * Spondylolisthesis; * Trauma, including fracture or dislocation; * Spinal stenosis; * Curvatures, including scoliosis, kyphosis, and/or lordosis; * Tumor; * Pseudoarthrosis; and * Failed previous fusion. | | | | 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) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} K262091, Page 1 of 3 | 510(k) #: | 510(k) Summary | Prepared on: 2026-06-22 | | --- | --- | --- | | Contact Details | | 21 CFR 807.92(a)(1) | | Applicant Name | Ortler Global Tibbi Gerecler Anonim Sirketi | | --- | --- | | Applicant Address | IVEDIKKOY MAH., 1492 CADDE, 17 B, 43, YENIMAHALLE Ankara 06378 Turkey | | Applicant Contact Telephone | +905356949313 | | Applicant Contact | Mr. TAHA CIBIR | | Applicant Contact Email | ortlerfda@gmail.com | | Correspondent Name | Mr. Victor Weaver | | Correspondent Address | null United States | | Correspondent Contact Telephone | +905323973043 | | Correspondent Contact | Mr. Victor Weaver | | Correspondent Contact Email | 9342mdd@gmail.com | | Device Name | 21 CFR 807.92(a)(2) | | --- | --- | | Device Trade Name | FRAXION Spinal Fixation System | | Common Name | Thoracolumbosacral pedicle screw system | | Classification Name | Thoracolumbosacral Pedicle Screw System | | Regulation Number | 888.3070 | | Product Code(s) | NKB, KWP, KWQ | | Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) | | --- | --- | --- | | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | K212220 | ArtFX Spinal Fixation System | NKB | | Device Description Summary | 21 CFR 807.92(a)(4) | | --- | --- | The FRAXION Spinal Fixation System is a top-loading, multiple-component posterior spinal fixation system intended to provide immobilization and stabilization of non-cervical spinal segments in skeletally mature patients as an adjunct to fusion using autograft or allograft. The system is used for anterior/anterolateral and posterior non-cervical pedicle and non-pedicle fixation in the treatment of acute and chronic spinal instabilities or deformities, including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion. The device functions by creating a rigid spinal construct using bone-anchored screws, rods, setscrews, connectors, and hooks. Pedicle screws or hooks are placed into or onto the vertebral anatomy, longitudinal rods are seated into the screw or hook heads, and setscrews are tightened to lock the rod-screw or rod-hook interface. Once assembled, the construct limits motion between affected spinal segments, maintains alignment, supports load sharing, and provides mechanical stability during the spinal fusion process. The top- {5} K262091, Page 2 of 3 loading design allows the rod and setscrew to be inserted from above the screw head, facilitating intraoperative assembly and reducing procedural complexity. The scientific concept underlying the device is mechanical stabilization of the spine to support biological fusion. By immobilizing unstable or deformed spinal segments and maintaining the desired anatomical relationship between vertebrae, the system provides an environment that supports osseous fusion using autograft or allograft. The device does not achieve its primary intended effect by chemical action, metabolism, or pharmacological means; its function is based on mechanical fixation, load support, and stabilization. The system includes polyaxial pedicle screws, monoaxial pedicle screws, spondylolisthesis/reduction screws, cannulated screws, fenestrated screws, straight rods, pre-bent rods, transverse connectors, multiaxial transverse connectors, lateral connectors, axial extension connectors, domino connectors, laminar hooks, pedicular hooks, and setscrews. Polyaxial screws include a screw body, tulip head, and fastening component, allowing angular variability for construct alignment. Monoaxial screws have a fixed head. Cannulated screws allow placement over a guidewire. Reduction screws include an extended tulip head to assist rod reduction in spondylolisthesis cases. Rods are provided in straight and pre-bent configurations and may be contoured intraoperatively to match patient anatomy. Connectors and hooks provide additional construct options to improve fixation, accommodate anatomy, or increase construct stability. All implantable components are manufactured from titanium alloy Ti6Al4V-ELI conforming to ASTM F136. Components may be anodized for color coding and identification; anodizing forms a titanium dioxide surface layer. Components are also laser-marked for product identification. The system is supplied non-sterile, for single use only, and is available in multiple sizes to accommodate patient anatomy and surgical requirements. Significant physical characteristics include screw diameters generally ranging from 4.5 mm to 8.0 mm depending on screw type, screw lengths varying by configuration, compatibility with 5.5 mm and/or 6.0 mm rods, smooth cylindrical rods in various lengths, and threaded setscrews that lock the rod within the screw or hook head. The screw heads include U-shaped slots and threaded internal walls to receive the rod and setscrew. The screw bodies include self-tapping, tapered threaded designs to support insertion into vertebral bone. The polyaxial screw design allows angular adjustment before final locking, while the setscrew design secures the rod and minimizes the potential for misalignment or cross-threading. The principal performance characteristics of the FRAXION Spinal Fixation System are its ability to provide spinal immobilization, stabilization, construct rigidity, rod-screw locking strength, and resistance to expected mechanical loads during the fusion period. The system is designed to maintain spinal alignment, support fusion, and withstand loads associated with non-cervical spinal fixation when used according to the surgical technique and instructions for use. ## Intended Use/Indications for Use 21 CFR 807.92(a)(5) FRAXION SPINAL FIXATION SYSTEM is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the FRAXION SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: - Degenerative disc disease (DDD), defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; - Spondylolisthesis; - Trauma, including fracture or dislocation; - Spinal stenosis; - Curvatures, including scoliosis, kyphosis, and/or lordosis; - Tumor; - Pseudoarthrosis; and - Failed previous fusion. ## Indications for Use Comparison 21 CFR 807.92(a)(5) The indications for use of the FRAXION Spinal Fixation System are the same as the predicate device, Artfx Spinal Fixation System (K212220). The subject device and predicate device are both intended for use in the non-cervical spine as anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation systems to provide additional support during fusion using autograft or allograft in skeletally mature patients for the treatment of the same acute and chronic instabilities or deformities, including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion. There are no differences in indications for use between the subject device and the predicate device. In addition, the subject device is identical to the predicate device with respect to intended use, technological characteristics, design, materials, manufacturing process, performance specifications, and method of use. The predicate device manufacturer, Artfx, will manufacture the FRAXION Spinal Fixation System using the same design, materials, manufacturing processes, equipment, quality system controls, technological characteristics, and performance specifications as the device cleared under K212220. {6} K262091, Page 3 of 3 Therefore, the indications for use are the same as the predicate device and do not constitute a new intended use. ## Technological Comparison 21 CFR 807.92(a)(6) The FRAXION Spinal Fixation System has the same technological characteristics as the predicate device, Artfx Spinal Fixation System (K212220). The subject device and predicate device have the same design, materials, chemical composition, principle of operation, sterility status, method of use, and performance specifications. Both devices are top-loading, multiple-component spinal fixation systems consisting of pedicle screws, rods, connectors, hooks, and setscrews. The subject device uses the same rod-screw-setscrew interconnection mechanism as the predicate device. After the screws are placed in the spine, the rod is seated into the U-shaped slot of the screw head and locked using a setscrew to create a spinal fixation construct. The subject device and predicate device are manufactured from the same implant material, Ti6Al4V-ELI titanium alloy conforming to ASTM F136. The material composition, biocompatibility profile, corrosion resistance, mechanical strength, and fatigue strength are the same as the predicate device. The device is non-powered and does not use an energy source. Its principle of operation is mechanical stabilization and immobilization of non-cervical spinal segments as an adjunct to fusion. The function of the subject device is the same as the predicate device: to act as a spinal implant construct to stabilize and promote spinal fusion. The subject device is identical to the predicate device cleared under K212220 with respect to design, materials, technological characteristics, interconnection mechanism, performance specifications, and intended use. Therefore, the FRAXION Spinal Fixation System has the same technological characteristics as the predicate device. No technological differences exist that raise different questions of safety or effectiveness. ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) The FRAXION Spinal Fixation System is identical to the predicate device, Artfx Spinal Fixation System (K212220), with respect to intended use, indications for use, design, materials, technological characteristics, principle of operation, interconnection mechanism, manufacturing approach, sterility status, and performance specifications. Therefore, the nonclinical performance information relied upon for substantial equivalence is based on the previously established performance data for the predicate device and the mechanical evaluation provided in K212220, including ASTM F1717 (static and dynamic compression bending, static torsion) and ASTM F1798 (axial grip, torsional grip, static flexion-extension). The information presented demonstrates the substantial equivalence of the subject device.