TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
K253195 · ZheJiang Decans Medical Devices Co., Ltd. · NKG · Jun 2, 2026 · Orthopedic
Device Facts
Record ID
K253195
Device Name
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
Applicant
ZheJiang Decans Medical Devices Co., Ltd.
Product Code
NKG · Orthopedic
Decision Date
Jun 2, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3075
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine and the thoracic spine (Occiput-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Device Story
TAURUS Posterior Occipital-Cervico-Thoracic Spinal System is a posterior spinal fixation implant set; includes rods, screws, connectors, crosslinks, occipital plates, and laminar hooks. Used by surgeons in hospital settings to achieve stable fixation of two or more vertebral segments. Implants are customized to patient anatomy and locked in place to promote fusion or provide temporary stabilization in tumor cases. System is non-sterile, single-use, and manufactured from Ti-6Al-4V. Provides mechanical support to the spinal column to facilitate healing or manage instability.
Clinical Evidence
No clinical or animal study data submitted. Substantial equivalence is supported by non-clinical bench testing, including static and dynamic mechanical performance evaluations (bending, torque, pullout, and gripping capacity) conducted per ASTM F2193, F543, F1798, and F2706 standards. Sterilization efficacy validated to SAL 10⁻⁶ per ISO 17665:2024.
Technological Characteristics
Constructed from Ti-6Al-4V (ISO 5832-3). System components include rods, screws, connectors, crosslinks, occipital plates, and laminar hooks. Mechanical fixation via screw-rod-connector assembly. Non-sterile, single-use implants; reusable instruments. Sterilization via moist heat (ISO 17665:2024).
Indications for Use
Indicated for adults requiring immobilization and stabilization of craniocervical junction, cervical spine, and thoracic spine (Occiput-T3) as an adjunct to fusion for traumatic fractures/dislocations, instability, deformity, pseudarthrosis, tumors, or degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for temporary spinal column stabilization in patients with advanced cervical tumors where fusion is not feasible due to limited life expectancy.
Regulatory Classification
Identification
Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Special Controls
*Classification.* Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
*e.g.,* CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 2, 2026
ZheJiang Decans Medical Devices Co., Ltd.
Haifeng Liu
RA Manager
No.2836,Xincheng Avenue,Gaozhao Street,Xiuzhou District
Jiaxing City, Zhejiang Province,314031,P.R. China
Jiaxing, Zhejiang
China
Re: K253195
Trade/Device Name: TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
Regulation Number: 21 CFR 888.3075
Regulation Name: Posterior Cervical Screw System
Regulatory Class: Class II
Product Code: NKG, KWP
Dated: May 14, 2026
Received: May 15, 2026
Dear Haifeng Liu:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253195 - Haifeng Liu
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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" (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-
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K253195 - Haifeng Liu
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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).
Sincerely,
Colin O'Neill, M.B.E.
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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# 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. | K253195 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | | |
| Please provide your Indications for Use below. | | ? |
| TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine and the thoracic spine (Occiput-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of 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) | ? |
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# 510(k) Summary
This 510(k) Summary has been prepared in accordance with 21 CFR §807.92.
Date of Preparation: 15 September 2025
## 1. Submitter and Contact
### Submitter
ZheJiang Decans Medical Devices Co., Ltd.
No.2836 Xincheng Avenue, Gaozhao Street, Xiuzhou District, Jiaxing City, Zhejiang Province, 314031, P.R.China
### Contact
Contact Person: Haifeng Liu, RA Manager
Telephone: +86 15210058659
Email: hfliu@decansmd.com
Correspondent: Peiwen Feng, RA
Telephone: +86 18758326652
Email: pwfeng@decansmd.com
## 2. Identification of Subject Device
Trade Name: TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
Regulation Number: 21 CFR 888.3075
Regulation Name: Posterior cervical screw system
Classification: II
Product Code: NKG
Associated Product Code: KWP
Review Panel: Orthopedic
Materials: Ti6Al4V
Patient contact: Bone and surrounding tissue
Contact duration: Permanent, >30 days
Sterilization method: Moist heat sterilization
Environment of Use: Healthcare facility/Hospital
Single Use: Yes
Provided status: Non-sterile
## 3. Identification of Predicate Device(s)
#### ➤ Primary predicate device
| Product Name | VERTEX™ Reconstruction System |
| --- | --- |
| Manufacturer | Medtronic Sofamor Danek USA, Inc. |
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| 510 (k) | K180851 |
| --- | --- |
| Regulation number | 21CFR888.3075 |
| Regulation Name | Posterior Cervical Screw System |
| Regulation class | Class II |
| Product code | NKG,KWP |
| Review panel | Orthopedic |
# ➤ **Additional predicate device**
| Product Name | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System | Posterior cervical Spine System |
| --- | --- | --- |
| 510 (k) | K190895 | K233078 |
| Manufacturer | Medos International SARL % | Double Medical Technology, Inc. |
| Regulation number | 21CFR888.3075 | 21CFR888.3075 |
| Regulation Name | Posterior Cervical Screw System | Posterior Cervical Screw System |
| Regulation class | Class II | Class II |
| Product code | NKG,KWP,HWC,HRS | NKG,KWP |
| Review panel | Orthopedic | Orthopedic |
# ➤ **Reference predicate**
| Product Name | VERTEX® Reconstruction System |
| --- | --- |
| 510 (k) | K110522 |
| Manufacturer | Medtronic Sofamor Danek USA, Inc. |
| Regulation number | 21CFR888.3050 |
| Regulation Name | Spinal interlaminal fixation orthosis |
| Regulation class | Class II |
| Product code | KWP |
| Review panel | Orthopedic |
#### 4. Indications for Use
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine and the thoracic spine (Occiput-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis);
K253195 Page 2 of 4
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tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
## 5. Device Description
The TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems consists of rods, screws, connectors, crosslink, occipitocervical bone screws, occipital plates, laminar hooks and set screw. It can be firmly locked in multiple configurations and is suitable for each case to be customized with each structure. The implanted part can achieve stable fixation of two or more vertebral segments and can be removed when its stabilizing function is no longer needed.
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems is a posterior cervical fixation system designed to effectively promote occipitocervical, cervical, and thoracic posterior fixation and fusion.
The implants are made from Ti-6Al-4V per ISO 5832-3. The implants and instruments are provided non-sterile. The implants are intended for single-use only, while the instruments are reusable.
## 6. SE Comparison of Indications for Use and Technological Characteristics
The subject device and predicate devices are equivalent in indications for use and technological characteristics.
The technological similarities identified between the subject and predicate devices are considered minor and won't impact substantial equivalence.
## 7. Test Summary
### **➤ Standard Performance Test**
A series of side-by-side tests have been conducted on subject and predicate, in order to support mechanical equivalence, including following:
Four-point bending test (static&dynamic) per ASTM F2193
Driving torque test per ASTM F2193
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Axial pullout strength test per ASTM F543
Torsional properties test per ASTM F2193
Static axial torque test per ASTM F1798
Static axial gripping capacity test per ASTM F1798
Flexion extension moment test per ASTM F1798
Axial compression bending test (static&dynamic) per ASTM F2706
Torsion test (static&dynamic) per ASTM F2706
Screw bending test (static&dynamic) per ASTM F2193
Static axial tensile bending test per ASTM F2706
# ➤ **Sterilization efficacy validation**
The recommended sterilization method for subject device is moist heat sterilization. The sterilization validation has been performed on an representative product in accordance with ISO 17665:2024. A sterility assurance level (SAL) of 10⁻⁶ has been demonstrated.
## 8. Performance-Clinical or Animal
No animal study data is submitted in this 510(k).
No clinical study data is submitted in this 510(k).
## 9. Conclusion
Comparison of indications for use, technological characteristics and nonclinical bench testing demonstrate the TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems is substantially equivalent to the predicate devices.
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