# K241413: sagAlign Lumbar Cage System (Various PNs)

- Pathway: 510(k) (Traditional)
- Applicant: Acuity Surgical Devices, LLC
- Decided: Jul 17, 2024 after 61 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: 25 generations back to K841189 (1984). 410 ancestors in all.
No later device cites it as a predicate yet.
1 of 411 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080537: L-Varlock, Kiscomedica S.A. (2008) Summary page 4.
- K222561: Align, Acuity Surgical Devices, LLC (2022) Summary page 4.
- K221535: Align Lumbar Interbody Fusion System, Acuity Surgical Devices, LLC (2022) Summary page 4.

## Indications for use
The sagAlign Lumbar Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). sagAlign Lumbar Cage implants are to be used with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft and implanted via an open posterior approach. sagAlign Lumbar Cage implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K241413
Methodology: https://510kreport.com/methodology