# K243106: CarboClear® Hybrid Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Nov 5, 2024 after 36 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: 25 generations back to K040583 (2004). 659 ancestors in all.
No later device cites it as a predicate yet.
2 of 660 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233793: CarboClear® X Pedicle Screw System, CarboFix Orthopedics, Ltd. (2024) Summary page 6.
- 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, CarboFix Orthopedics, Ltd. (2024) Summary page 6.
- K082236: CD Horizon Spinal System, Medtronic Sofamor Danek (2008) Summary page 6.
- K130291: S4 Spinal System, Aesculap Implant System, Inc. (2013) Summary page 6.
- K192930: Dymaxeon Spine System, Back 2 Basics Direct, LLC (2020) Summary page 6.

## Indications for use
CarboClear® Hybrid Pedicle Screw System (DDD) The CarboClear® Hybrid 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 up to three levels 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® Hybrid Pedicle Screw System is intended to be used with intervertebral body fusion device/s 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/K243106
Methodology: https://510kreport.com/methodology