# K233989: CarboClear® Posterior Cervical Screw System

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Mar 27, 2024 after 100 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: 21 generations back to K040583 (2004). 455 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 458 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 5.
- K153370: Caspian OCT/MESA Mini/DENALI Mini Spinal System, K2m, Incorporated (2016) Summary page 5.
- K210716: CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments, CarboFix Orthopedics, Ltd. (2021) Summary page 5.

## Most influential descendants
- K252327: CMORE® CT System; CMORE® CT System Navigated Instruments (2025), 1 descendant of its own
- K254045: CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System (2026), 0 descendants of its own

## Indications for use
The CarboClear® 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.

Source page: https://510kreport.com/device/K233989
Methodology: https://510kreport.com/methodology