# K243739: AxCess® Expandable Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Elliquence, LLC
- Decided: Jan 24, 2025 after 51 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: 26 generations back to K841189 (1984). 307 ancestors in all.
No later device cites it as a predicate yet.
1 of 308 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182877: HALF DOME Posterior Lumbar Interbody System, Astura Medical, LLC (2019) Summary page 6.
- K213951: FORZA XP Expandable Spacer System, Orthofix US, LLC (2022) Summary page 6.

## Indications for use
The AxCess® Expandable Interbody System is a lumbar intervertebral body fusion device and is indicated for spinal fusion procedures to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients. The devices are intended for use at either one or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. The device is not intended to be used as a stand-alone device. For all the above indications the devices must be used with supplemental internal spinal fixation system that have been cleared for use in the lumbar spine, including Pedicle Screw and Hook Systems, and Spinal Plate Systems.

Source page: https://510kreport.com/device/K243739
Methodology: https://510kreport.com/methodology