# K210716: CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments

- Pathway: 510(k) (Special)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Apr 6, 2021 after 27 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: 20 generations back to K040583 (2004). 362 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 371 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203317: CarboClear X Pedicle Screw System, CarboFix Orthopedics, Ltd. (2020) Summary page 6.
- K201251: CarboClear Navigated Instruments, CarboFix Orthopedics, Ltd. (2020) Summary page 6.
- K981676: CD Horizon Spinal System, Sofamor Danek USA,Inc. (1999) Summary page 6.
- K130291: S4 Spinal System, Aesculap Implant System, Inc. (2013)
- K992739: Click'x, Synthes Spine (2000) Summary page 6.
- K052398: Mesa Spinal System, K2m, LLC (2005) Summary page 6.
- K173487: CarboClear® Pedicle Screw System, CarboFix Orthopedics, Ltd. (2018) Summary page 6.
- K182377: CarboClear® Pedicle Screw System, CarboFix Orthopedics, Ltd. (2018) Summary page 6.
- K201926: CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System, CarboFix Orthopedics, Ltd. (2020) Summary page 6.
- K153442: CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 6.

## Most influential descendants
- K231280: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement (2023), 4 descendants of its own
- 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
- K233989: CarboClear® Posterior Cervical Screw System (2024), 2 descendants of its own
- K252327: CMORE® CT System; CMORE® CT System Navigated Instruments (2025), 1 descendant 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.

Source page: https://510kreport.com/device/K210716
Methodology: https://510kreport.com/methodology