# K233944: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments

- Pathway: 510(k) (Special)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Jan 10, 2024 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: 22 generations back to K040583 (2004). 637 ancestors in all.
3 later devices descend from it; 2 cite it directly.
2 of 641 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232341: CarboClear® Pedicle Screw System, CarboFix Orthopedics, Ltd. (2023) Summary page 5.
- K210716: CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments, CarboFix Orthopedics, Ltd. (2021) Summary page 5.
- K231280: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement, CarboFix Orthopedics, Ltd. (2023) Summary page 5.
- K173487: CarboClear® Pedicle Screw System, CarboFix Orthopedics, Ltd. (2018) Summary page 5.
- K201926: CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System, CarboFix Orthopedics, Ltd. (2020) Summary page 5.
- K082236: CD Horizon Spinal System, Medtronic Sofamor Danek (2008) Summary page 5.
- K130291: S4 Spinal System, Aesculap Implant System, Inc. (2013) Summary page 5.

## Most influential descendants
- 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 provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear@ X Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. 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/K233944
Methodology: https://510kreport.com/methodology