The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System is 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. The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System is intended to provide immobilization and stabilization of spinal segments with anterior interbody support implanted at the same spinal level/s as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine and the upper thoracic spine (T1 to T3): - Traumatic spinal fractures and/or dislocations - Instability and deformity - Failed previous fusions (e.g., pseudarthrosis) - Degenerative disease, including intractable radiculopathy and/or myelopathy - Neck and/or arm pain of discogenic origin as confirmed by radiographic studies - Degenerative disease of the facets with instability - Patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System is intended to be used with anterior interbody support implanted at the same spinal level/s with autogenous and /or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Device Story
System comprises spinal implants (screws, rods) and surgical instruments; used to build spinal constructs for immobilization/stabilization. Screws feature carbon fiber-reinforced PEEK (CFR-PEEK) bodies; some models include titanium alloy tulips/shells and tantalum markers. Rods available in CFR-PEEK or titanium alloy. Used in clinical/surgical settings by surgeons to treat spinal instability or tumors. Implants provide mechanical support to spinal segments; intended to facilitate fusion or provide temporary structural integrity in tumor cases. Benefits include spinal stabilization and restoration of column integrity. Supplied sterile for single use.
Clinical Evidence
Bench testing only. Performance characteristics evaluated via static and dynamic compression bending tests (ASTM F1717), flexion-extension, axial and torsional gripping capacity (ASTM F1798), and wear evaluation. Results demonstrate performance comparable to predicate devices.
Indicated for patients with advanced stage cervical tumors (limited life expectancy); acute/chronic cervical and upper thoracic (T1-T3) instabilities including traumatic fractures/dislocations, deformity, failed fusions, degenerative disease (radiculopathy/myelopathy/discogenic pain/facet instability), and spinal infection. Requires use with anterior interbody support and bone graft.
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
March 16, 2026
CarboFix Orthopedics, Ltd.
Yael Rubin
Director of Regulatory Affairs
11 Ha'Hoshlim St.
Herzeliya, 4672411
Israel
Re: K254045
Trade/Device Name: CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
Regulation Number: 21 CFR 888.3075
Regulation Name: Posterior Cervical Screw System
Regulatory Class: Class II
Product Code: NKG
Dated: December 16, 2025
Received: December 17, 2025
Dear Yael Rubin:
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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K254045 - Yael Rubin
Page 2
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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K254045 - Yael Rubin
Page 3
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 -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. | K254045 | ? |
| Please provide the device trade name(s). | | ? |
| CarboClear® Posterior Cervical Screw System ;
CarboClear® Hybrid Posterior Cervical Screw System | | |
| Please provide your Indications for Use below. | | ? |
| The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System
is 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.
The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System
is intended to provide immobilization and stabilization of spinal segments with anterior interbody support
implanted at the same spinal level/s as an adjunct to fusion for the following acute and chronic instabilities
of the cervical spine and the upper thoracic spine (T1 to T3):
- Traumatic spinal fractures and/or dislocations
- Instability and deformity
- Failed previous fusions (e.g., pseudarthrosis)
- Degenerative disease, including intractable radiculopathy and/or myelopathy
- Neck and/or arm pain of discogenic origin as confirmed by radiographic studies
- Degenerative disease of the facets with instability
- Patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection,
surgical debridement, or decompression
The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System
is intended to be used with anterior interbody support implanted at the same spinal level/s with autogenous
and /or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. | | |
| 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}
KarboFix Orthopedics Ltd.
CarboClear® Posterior Cervical Screw System
CarboClear® Hybrid Posterior Cervical Screw System
K254045 Page 1 of 4
# 510(k) Summary
CarboFix Orthopedics Ltd.
CarboClear® Posterior Cervical Screw System
CarboClear® Hybrid Posterior Cervical Screw System
## Applicant Name
CarboFix Orthopedics Ltd.
11 Ha’hoshlim St., Herzeliya 4672411, Israel
Tel: +972 9 9511511, Fax: +972 9 9548939
## Contact Person
Yael Rubin
CarboFix Orthopedics Ltd.
11 Ha’hoshlim St., Herzeliya 4672411, Israel
Tel: +972 9 9511511, Fax: +972 9 9548939
## Date Prepared
December 2025
## Trade/Proprietary Name
CarboClear® Posterior Cervical Screw System
CarboClear® Hybrid Posterior Cervical Screw System
## Common Name
Posterior, Cervical Spine Fixation
## Regulation Number and Device Class
Class II; 21 CFR §888.3075
## Product Code, Regulatory Description and Review Panel
NKG, Posterior Cervical Screw System, Orthopedic
{5}
KarboFix Orthopedics Ltd.
CarboClear® Posterior Cervical Screw System
CarboClear® Hybrid Posterior Cervical Screw System
K254045
Page 2 of 4
# Predicate Devices
## Primary Predicate Device:
- CMORE® CT System (icotec; K252327)
## Additional Predicate Devices:
- CarboClear® Posterior Cervical Screw System (CarboFix Orthopedics Ltd.; K233989)
- INFINITY™ OCT System (Medtronic; K163375)
## Reference Device:
- CarboClear® Hybrid Pedicle Screw System (CarboFix Orthopedics Ltd.; K240846, K243106)
# Indications for Use
The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System is 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.
The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System is intended to provide immobilization and stabilization of spinal segments with anterior interbody support implanted at the same spinal level/s as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine and the upper thoracic spine (T1 to T3):
- Traumatic spinal fractures and/or dislocations
- Instability and deformity
- Failed previous fusions (e.g., pseudarthrosis)
- Degenerative disease, including intractable radiculopathy and/or myelopathy
- Neck and/or arm pain of discogenic origin as confirmed by radiographic studies
- Degenerative disease of the facets with instability
- Patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression
The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System is intended to be used with anterior interbody support implanted at the same
{6}
CarboFix Orthopedics Ltd.
CarboClear® Posterior Cervical Screw System
CarboClear® Hybrid Posterior Cervical Screw System
K254045 Page 3 of 4
spinal level/s with autogenous and /or allogenic bone graft comprised of cancellous and/ or corticocancellous bone graft.
## System Description
CarboClear® Posterior Cervical Screw System (“CarboClear® System”) and CarboClear® Hybrid Posterior Cervical Screw System (“CarboClear® Hybrid System”) are composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants.
The screws incorporated into the systems are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with the CarboClear® Hybrid screws incorporating titanium alloy tulip. The screws threaded portion, and spherical head are encased within a thin titanium shell, and they may include a tantalum marker. The CarboClear® posterior cervical screws are used with CFR-PEEK set screw, and the CarboClear® Hybrid posterior cervical screws are used with a titanium alloy set screw. All screws are used with CarboClear® CFR-PEEK rods. CarboClear® titanium alloy rods are also offered.
The implants are supplied sterile, and are intended for single use.
## Purpose of Submission
Modification to the previously cleared CarboClear® Posterior Cervical Screw System (K233989) – modification to indications for use and addition of implants, and addition of CarboClear® Hybrid Posterior Cervical Screw System.
## Performance Data
Performance characteristics included static and dynamic compression bending tests according to ASTM F1717, ASTM F1798 (flexion-extension and axial and torsional gripping capacity), and wear evaluation. The results of the tests are comparable to those of the predicate devices, demonstrating substantially equivalent performance of the subject and predicate devices.
## Substantial Equivalence
The intended use, design, dimensions, materials, technological characteristics, principles of operation, and performance of the CarboClear®- and CarboClear® Hybrid Posterior Cervical Screw Systems are substantially equivalent to those of the predicate devices, as applicable.
{7}
K254045
Page 4 of 4
CarboFix Orthopedics Ltd.
CarboClear® Posterior Cervical Screw System
CarboClear® Hybrid Posterior Cervical Screw System
## Conclusion
Based on the information provided in this Premarket Notification, the CarboClear®- and CarboClear® Hybrid Posterior Cervical Screw Systems are substantially equivalent to their predicate devices.
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