# K192214: CarboClear VBR System

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Oct 11, 2019 after 57 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K841189 (1984). 207 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 209 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112429: Giza (R) Vertebral Body Replacement, Eden Spine, LLC (2012) Summary page 5.
- K173787: X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System, Medos International SARL (2018) Summary page 5.
- K140759: Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar, Cougar System, Cougar LS Lateral, Medos International SARL (2014) Summary page 5.
- K073649: Bengal Stackable Cage System, Depuy Spine, Inc. (2008) Summary page 5.
- K070173: Verte-Stack Spinal System, Medtronic Sofamor Danek, Inc. (2007) Summary page 5.

## Most influential descendants
- K222874: CarboClear Cervical Cage System, CarboClear Cervical VBR System (2023), 0 descendants of its own

## Indications for use
The CarboClear Vertebral Body Replacement (VBR) System is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The CarboClear Vertebral Body Replacement device is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of allograft or autograft with the CarboClear Vertebral Body Replacement device is optional.

Source page: https://510kreport.com/device/K192214
Methodology: https://510kreport.com/methodology