# K222874: CarboClear Cervical Cage System, CarboClear Cervical VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Carbofix Orthpedics, Ltd.
- Decided: Jul 26, 2023 after 307 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- 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 K841189 (1984). 352 ancestors in all.
No later device cites it as a predicate yet.
1 of 353 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160154: ALTA Anterior Cervical Interbody Spacer, Astura Medical (2016) Summary page 6.
- K183588: Choice Spine Hawkeye Vertebral Body Replacement (VBR) System, Choicespine (2019) Summary page 6.
- K193378: CarboClear Lumbar Cage System, CarboFix Orthopedics, Ltd. (2020) Summary page 6.
- K203683: CarboClear Lumbar Cage System, Carbofix Orthpedics, Ltd. (2021) Summary page 6.
- K192214: CarboClear VBR System, CarboFix Orthopedics, Ltd. (2019) Summary page 6.

## Indications for use
The CarboClear Cervical Cage System is indicated for intervertebral body fusion procedures of the cervical spine in skeletally mature patients with degenerative disc disease (DDD) at levels C2 — T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with the CarboClear Cervical Cage System. The CarboClear Cervical Vertebral Body Replacement (VBR) System Spacers are vertebral body replacement devices intended for use in the cervical spine (C2 — T1). The CarboClear Cervical VBR devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The spacers are 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion. The devices are intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the cervical spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation. The use of allograft or autograft with the CarboClear Cervical VBR device is optional.

Source page: https://510kreport.com/device/K222874
Methodology: https://510kreport.com/methodology