# K252327: CMORE® CT System; CMORE® CT System Navigated Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Icotec AG
- Decided: Nov 12, 2025 after 110 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K040583 (2004). 837 ancestors in all.
1 later device descends from it; 1 cites it directly.
10 of 839 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242516: EUROPA™ Posterior Cervical Fusion System, MiRus, LLC (2024) Summary page 5.
- K233989: CarboClear® Posterior Cervical Screw System, CarboFix Orthopedics, Ltd. (2024) Summary page 5.
- K231850: QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments, Globus Medical, Inc. (2024) Summary page 5.

## Most influential descendants
- K254045: CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System (2026), 0 descendants of its own

## 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 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.

Source page: https://510kreport.com/device/K252327
Methodology: https://510kreport.com/methodology