# K231280: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Jul 3, 2023 after 61 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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). 483 ancestors in all.
4 later devices descend from it; 3 cite it directly.
2 of 488 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193423: VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0, Icotec AG (2020) Summary page 7.
- K200596: G21 Cement, VADER® Pedicle System, Icotec AG (2020) Summary page 7.
- K162912: VIPER PRIME™ additions to the VIPER® System, Medos International SARL (2016) Summary page 7.
- K170937: VIPER PRIME navigated inserter, Medos International SARL (2017) Summary page 7.
- K210716: CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments, CarboFix Orthopedics, Ltd. (2021) Summary page 7.
- K190526: High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws, CarboFix Orthopedics, Ltd. (2019) Summary page 7.

## Most influential descendants
- K233944: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments (2024), 3 descendants of its own
- K240846: CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement (2024), 2 descendants of its own
- K233793: CarboClear® X Pedicle Screw System (2024), 1 descendant of its own
- K243106: CarboClear® Hybrid Pedicle Screw System (2024), 0 descendants of its own

## Indications for use
The CarboClear® X Pedicle 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CarboClear® X Navigated Instruments are intended to be used during the preparation and placement of CarboClear® X Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® X Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. When used in conjunction with High V+ ® Bone Cement, the CarboClear® X Fenestrated Pedicle 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The CarboClear® X Fenestrated Pedicle Screw System augmented with High V+® Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised. When used in conjunction with the CarboClear® X Fenestrated Pedicle Screw System, High V+® Bone Cement 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. High V+® Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

Source page: https://510kreport.com/device/K231280
Methodology: https://510kreport.com/methodology