← Product Code [NKB](/productcode/NKB) · K260362 # QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) (K260362) _MANTIZ Co., Ltd. · NKB · Jul 24, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K260362 ## Device Facts - **Applicant:** MANTIZ Co., Ltd. - **Product Code:** [NKB](/productcode/NKB.md) - **Decision Date:** Jul 24, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3070 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The QUATTRO Spinal System are 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 and pseudarthrosis ## Device Story QUATTRO Spinal system (Open) and QUATTRO-GADGET (MIS) are posterior thoracolumbosacral pedicle screw systems; provide temporary spinal stabilization as adjunct to fusion. System components include pedicle screws, longitudinal rods, set screws, and optional cross-links; assembled intraoperatively by surgeons. Principle of operation: rigid mechanical anchoring of pedicle screws into vertebrae; coupling with rods to restrict motion across spinal segments; promotes bony fusion. No active electronic components; purely mechanical fixation. Used in clinical/OR settings. Benefits: stabilization of spinal column until solid bony fusion occurs. ## Clinical Evidence Bench testing only. Mechanical performance evaluated per ASTM F1717-21 (static compression bending, dynamic compression bending, and static torsion) in a vertebrectomy model. Results compared to predicate device data demonstrate comparable mechanical performance. ## Technological Characteristics Posterior thoracolumbosacral pedicle screw system. Materials: Ti-6Al-4V ELI (ASTM F136). Components: pedicle screws, rods, set screws, cross-links. Mechanical fixation principle; no electronics, software, or energy sources. Sterilization method not specified. Testing per ASTM F1717-21. ## Regulatory 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 - Goblin and Goblin LS Pedicle Screw Systems ([K210420](/device/K210420.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} [LOGO] FDA U.S. FOOD & DRUG ADMINISTRATION July 24, 2026 MANTIZ Co., Ltd. Jay Kim Senior Researcher 423-15, Hyeoksin-Daero Daegu, Dong 41701 Republic Of Korea Re: K260362 Trade/Device Name: QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: July 7, 2026 Received: July 7, 2026 Dear Jay Kim: 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} K260362 - Jay Kim 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} K260362 - Jay Kim Page 3 Sincerely, COLIN O'NEILL -S 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. | K260362 | ? | | Please provide the device trade name(s). | | ? | | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | | | | Please provide your Indications for Use below. | | ? | | The QUATTRO Spinal System are 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 and pseudarthrosis | | | | 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) | ? | {4} | 510(k) #: K260362 510(k) Summary Prepared on: 2026-07-07 | | | | --- | --- | --- | | Contact Details | | 21 CFR 807.92(a)(1) | | Applicant Name | MANTIZ Co.,Ltd. | | | Applicant Address | 423-15, Hyeoksin-daero Daegu Dong-gu 41071 Korea, Republic of | | | Applicant Contact Telephone | 82 10 6680 8429 | | | Applicant Contact | Mr. Jay Kim | | | Applicant Contact Email | kim.hj@mantiz.net | | | Device Name | | 21 CFR 807.92(a)(2) | | Device Trade Name | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | | | Common Name | Thoracolumbosacral pedicle screw system | | | Classification Name | Thoracolumbosacral Pedicle Screw System | | | Regulation Number | 888.3070 | | | Product Code(s) | NKB | | | Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) | | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | K210420 | Goblin and Goblin LS Pedicle Screw Systems | NKB | | Device Description Summary | | 21 CFR 807.92(a)(4) | | The subject device is a posterior thoracolumbosacral pedicle screw spinal fixation system intended to provide temporary stabilization of spinal segments as an adjunct to spinal fusion procedures. The system consists of multiple implant components, including pedicle screws, longitudinal rods, set screws, and optional cross-links, which are assembled intraoperatively to immobilize and stabilize the spine. The device functions by rigidly anchoring pedicle screws into the vertebrae and mechanically coupling them with rods to restrict motion across the treated spinal segments, thereby promoting conditions favorable for fusion. The scientific principle of operation is based on mechanical load sharing and stabilization of the spinal column until solid bony fusion occurs. The implant components are manufactured from titanium alloy materials commonly used in orthopedic spinal applications and are available in a range of sizes to accommodate patient anatomy. The system does not contain active electronic components and relies solely on mechanical fixation principles. | | | | Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) | | The QUATTRO Spinal System are 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; | | | K260362 Page 1 of 2 {5} • Trauma (i.e., fracture or dislocation); • Spinal stenosis; • Curvatures (i.e., scoliosis, kyphosis and/or lordosis); • Tumor and pseudarthrosis ## Indications for Use Comparison 21 CFR 807.92(a)(5) The Subject Device has the same intended use and identical indications for use as the predicate device, Goblin and Goblin LS Pedicle Screw Systems (K210420). Both devices are intended for posterior, non-cervical pedicle fixation as an adjunct to spinal fusion in skeletally mature patients with degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, spinal deformities, tumor, and pseudoarthrosis. Because the indications for use are the same, no new intended use is introduced. ## Technological Comparison 21 CFR 807.92(a)(6) The technological characteristics of the Subject Device are substantially equivalent to those of the predicate device, Goblin and Goblin LS Pedicle Screw Systems (K210420). Both systems are posterior, non-cervical pedicle screw fixation systems consisting of pedicle screws, rods, set screws, and optional transverse connectors. The design features, mechanical interface, and method of assembly are the same as those of the predicate. Both the Subject Device and predicate device are manufactured from Ti-6Al-4V ELI in accordance with ASTM F136, and all materials used in patient-contacting components share the same chemical composition and biocompatibility profile. The devices operate under the same principle of action-rigid spinal fixation through pedicle anchorage and rod stabilization-and do not include electronics, software, biologic materials, or energy-based components. Any dimensional variations within the screw or rod size ranges are minor and do not alter the mechanical behavior or clinical use of the system. Mechanical testing performed in accordance with ASTM F1717 (static compression bending, dynamic compression bending, and static torsion) demonstrates that the Subject Device performs at least as well as the predicate device, confirming that no new technological questions are introduced. Therefore, the Subject Device has the same technological characteristics as the predicate device and does not raise new issues of safety or effectiveness. ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Non-clinical bench testing was performed to support the substantial equivalence of the subject device. Performance testing of the subject device was conducted in accordance with ASTM F1717-21, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. The testing evaluated the mechanical performance of the spinal fixation system under representative loading conditions. The results of the subject device testing were compared against performance data from the legally marketed predicate device, including previously conducted dynamic compression, static torsion, and static compression testing. These non-clinical performance evaluations demonstrated that the subject device exhibits mechanical performance comparable to that of the predicate device. Not Applicable. Based on the results of non-clinical bench testing conducted in accordance with ASTM F1717-21, and a comparison with performance data from the legally marketed predicate device, the subject device demonstrates mechanical performance that is as safe and effective as the predicate device. The non-clinical performance data support the conclusion that the subject device is substantially equivalent to the predicate device for its intended use. K260362 Page 2 of 2 --- **Source:** [https://fda-staging.innolitics.com/device/K260362](https://fda-staging.innolitics.com/device/K260362) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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