# K221535: Align Lumbar Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Acuity Surgical Devices, LLC
- Decided: Jul 22, 2022 after 56 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: 24 generations back to K841189 (1984). 408 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 412 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 4.
- K201671: A-Link Z, Acuity Surgical Devices, LLC (2021) Summary page 4.
- K201614: TxTiHA IBF System, AxTiHA Stand-Alone ALIF System, Innovasis, Inc. (2020) Summary page 4.

## Most influential descendants
- K251335: Tera Lumbar Interbody Fusion System (Various PNs) (2025), 1 descendant of its own
- K254130: C.A. Medical Interbody Fusion System (2026), 0 descendants of its own
- K241413: sagAlign Lumbar Cage System (Various PNs) (2024), 0 descendants of its own

## Indications for use
The Align Lumbar 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. The Align Lumbar Interbody Fusion System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 Lumbar Interbody Fusion System is intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K221535
Methodology: https://510kreport.com/methodology