# K230478: Acro Composites Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Acro Composites, LLC
- Decided: Oct 19, 2023 after 239 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). 267 ancestors in all.
No later device cites it as a predicate yet.
1 of 268 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191537: eCarbon IBDs, Back 2 Basics Direct, LLC (2019) Summary page 5.
- K173148: ACIF, Coligne AG (2017) Summary page 5.
- K181963: ostaPek Interbody Fusion Cages, Coligne AG (2018) Summary page 5.
- K160125: Cascadia Interbody System, K2m (2016) Summary page 5.
- K172009: Cascadia Interbody System, K2m, Inc. (2017) Summary page 5.

## Indications for use
The Acro Composites Interbody System is intended for interbody fusion. The devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and are to be used with supplemental fixation cleared for the implanted level. The Acro Composites cervical devices are intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The cervical devices are 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 multiple contiguous levels from C2-T1. The hyperlordotic implants (> 10°) are required to be used with an anterior cervical plate. The Acro Composites lumbar devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The lumbar devices are indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRI). Additionally, the lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The hyperlordotic implants (> 20°) should be used with anterior supplemental fixation.

Source page: https://510kreport.com/device/K230478
Methodology: https://510kreport.com/methodology