# K232341: CarboClear® Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Oct 10, 2023 after 67 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 K853033 (1985). 471 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 476 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181119: Range (Denali and Mesa) Spinal Systems, K2m, Inc. (2018) Summary page 5.
- K173487: CarboClear® Pedicle Screw System, CarboFix Orthopedics, Ltd. (2018) Summary page 5.
- K082236: CD Horizon Spinal System, Medtronic Sofamor Danek (2008)
- K010515: Modification to Synergy Spinal System, Interpore Cross Intl. (2001) Summary page 5.
- K130291: S4 Spinal System, Aesculap Implant System, Inc. (2013) Summary page 5.
- K133350: Revere Stabilization System, Globus Medical, Inc. (2014) Summary page 5.

## 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 ® 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 ® 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.

Source page: https://510kreport.com/device/K232341
Methodology: https://510kreport.com/methodology