# K191537: eCarbon IBDs

- Pathway: 510(k) (Traditional)
- Applicant: Back 2 Basics Direct, LLC
- Decided: Sep 26, 2019 after 108 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: 20 generations back to K841189 (1984). 202 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 206 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160125: Cascadia Interbody System, K2m (2016) Summary page 4.
- K111792: Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini, Signus Medizintechnik GmbH (2012) Summary page 5.
- K043479: MC+ Partial VBR, Ldr Spine USA (2005) Summary page 5.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 5.

## Most influential descendants
- K203683: CarboClear Lumbar Cage System (2021), 1 descendant of its own
- K230478: Acro Composites Interbody System (2023), 0 descendants of its own
- K222874: CarboClear Cervical Cage System, CarboClear Cervical VBR System (2023), 0 descendants of its own

## Indications for use
The eCarbon-C is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The eCarbon-C is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one level or two contiguous levels from C2 - T1. The eCarbon-C is to be used with supplemental fixation. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion. The eCarbon-P is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, the eCarbon-P can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The eCarbon-P is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.

Source page: https://510kreport.com/device/K191537
Methodology: https://510kreport.com/methodology