# K254045: CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Mar 16, 2026 after 89 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: 23 generations back to K040583 (2004). 865 ancestors in all.
No later device cites it as a predicate yet.
10 of 866 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252327: CMORE® CT System; CMORE® CT System Navigated Instruments, Icotec AG (2025) Summary page 6.
- K233989: CarboClear® Posterior Cervical Screw System, CarboFix Orthopedics, Ltd. (2024) Summary page 6.
- K163375: INFINITY™ OCT System, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 6.

## 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 spinal level/s with autogenous and /or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Source page: https://510kreport.com/device/K254045
Methodology: https://510kreport.com/methodology