(110 days)
The CMORE® CT 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.
In patients requiring adjuvant radiotherapy following spinal stabilization, metal markers at the screw tips can be used as fiducial markers in radiotherapy treatments (e.g., SBRT, proton therapy).
The CMORE® CT 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 (C1 to C7) and the upper thoracic spine (T1 to T3):
- Traumatic spinal fractures and/or traumatic dislocations
- Instability or 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 CMORE® CT 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.
The CMORE® CT System may be connected to the VADER® Pedicle System using connectors.
CMORE® CT System Navigated Instruments
CMORE® CT System Navigated Instruments are intended to be used during the preparation and placement of the CMORE® CT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic StealthStation® and Brainlab Navigation Systems which are indicated for any medical condition in which the use of stereotactic surgery may by 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 of anatomy.
CMORE® CT System
The CMORE® CT System is a posterior cervical fixation system intended to provide structural stability and mechanical support to the cervical and upper thoracic spine. The CMORE® CT System is manufactured from Carbon/PEEK using a proprietary manufacturing process and is comprised of screws, rods, nut screws, and connectors as well as corresponding instruments.
CMORE® CT System System Navigated Instruments
The CMORE® CT System Navigated Instruments are reusable instruments used for the preparation and placement of FDA-cleared spinal bone screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed to be used with the Medtronic StealthStation® and Brainlab Navigation Systems. The instruments include awls, drills, probes, taps, drivers, and adapters.
N/A
FDA 510(k) Clearance Letter - CMORE® CT System
Page 1
November 12, 2025
icotec ag
℅ Michael Coladonato
Associate Director, Spine Regulatory Affairs
MCRA, LLC
803 7th Street, NW
Washington, District of Columbia 20001
Re: K252327
Trade/Device Name: CMORE® CT System; CMORE® CT System Navigated Instruments
Regulation Number: 21 CFR 888.3075
Regulation Name: Posterior Cervical Screw System
Regulatory Class: Class II
Product Code: NKG, OLO
Dated: October 8, 2025
Received: October 8, 2025
Dear Justin Eggleton:
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.
Page 2
K252327 - Justin Eggleton 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 systems (QS) regulation (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-
Page 3
K252327 - Justin Eggleton 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
Page 4
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. K252327
Please provide the device trade name(s).
CMORE® CT System;
CMORE® CT System Navigated Instruments
Please provide your Indications for Use below.
CMORE® CT System
The CMORE® CT 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.
In patients requiring adjuvant radiotherapy following spinal stabilization, metal markers at the screw tips can be used as fiducial markers in radiotherapy treatments (e.g., SBRT, proton therapy).
The CMORE® CT 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 (C1 to C7) and the upper thoracic spine (T1 to T3):
- Traumatic spinal fractures and/or traumatic dislocations
- Instability or 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 CMORE® CT 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.
The CMORE® CT System may be connected to the VADER® Pedicle System using connectors.
CMORE® CT System Navigated Instruments
CMORE® CT System Navigated Instruments are intended to be used during the preparation and placement of the CMORE® CT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic StealthStation® and Brainlab Navigation Systems which are indicated for any medical condition in which the use of stereotactic surgery may by 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 of anatomy.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
Page 5
510(k) Summary
Device Trade Name: CMORE® CT System, CMORE® CT System Navigated Instruments
Manufacturer: icotec ag
Industriestrasse 12
9450 Altstaetten
Switzerland
www.icotec-medical.com
Contact: Michael Coladonato
Associate Director, Spine Regulatory Affairs
MCRA, LLC
803 7th Street, NW
Washington, DC 20001
Phone: 202.552.5804
mcoladonato@mcra.com
Prepared by: MCRA, LLC
803 7th Street, NW
Washington, DC 20001
Office: 202.552.5800
Date Prepared: 11/10/2025
Classifications: 21 CFR §888.3075, Posterior cervical screw system
21 CFR §882.4560, Stereotaxic instrument
Class: II
Product Codes: NKG, OLO
Primary Predicate: EUROPA™ Posterior Cervical Fusion System (K242516)
Additional Predicate: CarboClear® Posterior Cervical Screw System (K233989)
ExcelsiusHub™ (K231850)
Reference Device: SYMPHONY™ OCT System (K181949)
Indications For Use:
CMORE® CT System
The CMORE® CT 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
K252327
Page 1 of 4
Page 6
K252327
Page 1 of 4
510(k) Summary
Device Trade Name: CMORE® CT System, CMORE® CT System Navigated Instruments
Manufacturer: icotec ag
Industriestrasse 12
9450 Altstaetten
Switzerland
www.icotec-medical.com
Contact: Michael Coladonato
Associate Director, Spine Regulatory Affairs
MCRA, LLC
803 7th Street, NW
Washington, DC 20001
Phone: 202.552.5804
mcoladonato@mcra.com
Prepared by: MCRA, LLC
803 7th Street, NW
Washington, DC 20001
Office: 202.552.5800
Date Prepared: 11/10/2025
Classifications: 21 CFR §888.3075, Posterior cervical screw system
21 CFR §882.4560, Stereotaxic instrument
Class: II
Product Codes: NKG, OLO
Primary Predicate: EUROPA™ Posterior Cervical Fusion System (K242516)
Additional Predicate: CarboClear® Posterior Cervical Screw System (K233989)
ExcelsiusHub™ (K231850)
Reference Device: SYMPHONY™ OCT System (K181949)
Indications For Use:
CMORE® CT System
The CMORE® CT 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
Page 7
the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In patients requiring adjuvant radiotherapy following spinal stabilization, metal markers at the screw tips can be used as fiducial markers in radiotherapy treatments (e.g., SBRT, proton therapy).
The CMORE® CT 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 (C1 to C7) and the upper thoracic spine (T1 to T3):
- Traumatic spinal fractures and/or traumatic dislocations
- Instability or 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 CMORE® CT 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.
The CMORE® CT System may be connected to the VADER® Pedicle System using connectors.
CMORE® CT System Navigated Instruments
CMORE® CT System Navigated Instruments are intended to be used during the preparation and placement of the CMORE® CT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic StealthStation® and Brainlab Navigation Systems which are indicated for any medical condition in which the use of stereotactic surgery may by 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 of anatomy.
Device Description:
CMORE® CT System
The CMORE® CT System is a posterior cervical fixation system intended to provide structural stability and mechanical support to the cervical and upper thoracic spine. The CMORE® CT System is manufactured from Carbon/PEEK using a proprietary manufacturing process and is comprised of screws, rods, nut screws, and connectors as well as corresponding instruments.
CMORE® CT System System Navigated Instruments
The CMORE® CT System Navigated Instruments are reusable instruments used for the preparation and placement of FDA-cleared spinal bone screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed to be
K252327
Page 2 of 4
Page 8
K252327
Page 2 of 4
the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In patients requiring adjuvant radiotherapy following spinal stabilization, metal markers at the screw tips can be used as fiducial markers in radiotherapy treatments (e.g., SBRT, proton therapy).
The CMORE® CT 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 (C1 to C7) and the upper thoracic spine (T1 to T3):
- Traumatic spinal fractures and/or traumatic dislocations
- Instability or 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 CMORE® CT 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.
The CMORE® CT System may be connected to the VADER® Pedicle System using connectors.
CMORE® CT System Navigated Instruments
CMORE® CT System Navigated Instruments are intended to be used during the preparation and placement of the CMORE® CT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic StealthStation® and Brainlab Navigation Systems which are indicated for any medical condition in which the use of stereotactic surgery may by 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 of anatomy.
Device Description:
CMORE® CT System
The CMORE® CT System is a posterior cervical fixation system intended to provide structural stability and mechanical support to the cervical and upper thoracic spine. The CMORE® CT System is manufactured from Carbon/PEEK using a proprietary manufacturing process and is comprised of screws, rods, nut screws, and connectors as well as corresponding instruments.
CMORE® CT System System Navigated Instruments
The CMORE® CT System Navigated Instruments are reusable instruments used for the preparation and placement of FDA-cleared spinal bone screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed to be
Page 9
used with the Medtronic StealthStation® and Brainlab Navigation Systems. The instruments include awls, drills, probes, taps, drivers, and adapters.
Predicate Device:
CMORE® CT System
icotec ag submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the CMORE® CT System is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices:
Primary Predicate: EUROPA™ Posterior Cervical Fusion System (K242516)
Additional Predicate: CarboClear® Posterior Cervical Screw System (K233989)
Reference Device: SYMPHONY™ OCT System (K181949)
CMORE® CT System Navigated Instruments
icotec ag submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the CMORE® CT System Navigated Instruments are substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices:
Additional Predicate: ExcelsiusHub™ (K231850)
Performance Testing Summary:
CMORE® CT System
The mechanical performance profile of the CMORE® CT System was assessed through static and dynamic testing in accordance with the following test methods:
- Static and dynamic compression bending per ASTM F1717
- Static torsion strength testing per ASTM F1717
- Static axial and torque gripping capacity per ASTM F1798
- Static flexion/extension bending strength per ASTM F1798
The summative usability evaluation was conducted on the CMORE® CT System markers as part of the final assessment of cervical posterior fixation implants. The evaluation took place in a wetlab environment using cadaver specimens and various imaging modalities. Orthopedic surgeons and radiation oncologists participated by providing feedback on implant visibility and imaging compatibility.
Results demonstrated that tantalum and titanium markers provided radiographic visibility with CT and MRI imaging modalities. The usability testing found no safety-related issues or deviations during the evaluation.
Overall, the implant markers were confirmed to be safe and effective for intra- and postoperative imaging, supporting their use in the device as intended.
K252327
Page 3 of 4
Page 10
K252327
Page 3 of 4
used with the Medtronic StealthStation® and Brainlab Navigation Systems. The instruments include awls, drills, probes, taps, drivers, and adapters.
Predicate Device:
CMORE® CT System
icotec ag submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the CMORE® CT System is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices:
Primary Predicate: EUROPA™ Posterior Cervical Fusion System (K242516)
Additional Predicate: CarboClear® Posterior Cervical Screw System (K233989)
Reference Device: SYMPHONY™ OCT System (K181949)
CMORE® CT System Navigated Instruments
icotec ag submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the CMORE® CT System Navigated Instruments are substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices:
Additional Predicate: ExcelsiusHub™ (K231850)
Performance Testing Summary:
CMORE® CT System
The mechanical performance profile of the CMORE® CT System was assessed through static and dynamic testing in accordance with the following test methods:
- Static and dynamic compression bending per ASTM F1717
- Static torsion strength testing per ASTM F1717
- Static axial and torque gripping capacity per ASTM F1798
- Static flexion/extension bending strength per ASTM F1798
The summative usability evaluation was conducted on the CMORE® CT System markers as part of the final assessment of cervical posterior fixation implants. The evaluation took place in a wetlab environment using cadaver specimens and various imaging modalities. Orthopedic surgeons and radiation oncologists participated by providing feedback on implant visibility and imaging compatibility.
Results demonstrated that tantalum and titanium markers provided radiographic visibility with CT and MRI imaging modalities. The usability testing found no safety-related issues or deviations during the evaluation.
Overall, the implant markers were confirmed to be safe and effective for intra- and postoperative imaging, supporting their use in the device as intended.
CMORE® CT System Navigated Instruments
The CMORE® CT System Navigated Instruments have been tested per ASTM F2554.
Substantial Equivalence:
The CMORE® CT System is composed of Carbon/PEEK, while the primary predicate device (K242516) is made of a Molybdenum-Rhenium composite. An additional predicate device (K233989) made of CFR-PEEK has been cleared for cervical and upper thoracic spine applications. Despite the differences in material composition, the technological characteristics of the CMORE® CT System do not raise new safety or effectiveness concerns.
The CMORE® CT System Navigated instruments and the corresponding additional predicate device (K231850) both use instrument mounted tracking arrays for navigation and allow for integration with CT or fluoroscopy-based imaging for anatomical referencing. The subject device and the predicate device have different navigation system compatibility, but this does not raise questions of safety and effectiveness.
The subject devices were demonstrated to be substantially equivalent to the predicate devices cited in the section above with respect to intended use, indications, design, and performance.
Conclusion:
The subject devices and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. The CMORE® CT System and the CMORE® CT System Navigated Instruments are as safe, as effective, and performs as well as, or better, than the predicate devices.
K252327
Page 4 of 4
§ 888.3075 Posterior cervical screw system.
(a)
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.(b)
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.