# K230639: Align Cervical Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Acuity Surgical Devices, LLC
- Decided: Dec 1, 2023 after 268 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: 25 generations back to K841189 (1984). 415 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 418 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133967: Interbody Cage System, Aurora Spine (2014) Summary page 5.
- K183705: IdentiTi Porous Ti Interbody System, Alphatec Spine, Inc. (2019) Summary page 5.

## Most influential descendants
- K251735: Stabilis SA Cervical Stand-Alone System (Various PNs) (2025), 1 descendant of its own
- K254130: C.A. Medical Interbody Fusion System (2026), 0 descendants of its own

## Indications for use
The Align Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. The Align Cervical Interbody Fusion System is intended for use at either one level or two contiguous levels in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Align Cervical Interbody Fusion System is intended to be used with supplemental spinal fixation system cleared for use in the cervical spine.

Source page: https://510kreport.com/device/K230639
Methodology: https://510kreport.com/methodology