# K193378: CarboClear Lumbar Cage System

- Pathway: 510(k) (Traditional)
- Applicant: CarboFix Orthopedics, Ltd.
- Decided: Mar 2, 2020 after 88 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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: 18 generations back to K841189 (1984). 216 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 219 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151773: CONCORDE Bullet Lumbar Interbody System, Medos International SARL (2015) Summary page 5.
- K152475: FORZA PTC Spacer System, Orthofix, Inc. (2016) Summary page 5.
- K172480: icotec Interbody Cage System, Icotec AG (2018) Summary page 5.

## Most influential descendants
- K203683: CarboClear Lumbar Cage System (2021), 1 descendant of its own
- K222874: CarboClear Cervical Cage System, CarboClear Cervical VBR System (2023), 0 descendants of its own

## Indications for use
The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels. CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine. Patients should have at least six months of non-operative treatment prior to surgery.

Source page: https://510kreport.com/device/K193378
Methodology: https://510kreport.com/methodology