# K251335: Tera Lumbar Interbody Fusion System (Various PNs)

- Pathway: 510(k) (Traditional)
- Applicant: Acuity Surgical Devices, LLC
- Decided: Jun 2, 2025 after 33 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). 411 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 413 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221535: Align Lumbar Interbody Fusion System, Acuity Surgical Devices, LLC (2022) Summary page 5.
- K243386: Ventris Intervertebral Body Fusion Device, Acuity Surgical Devices, LLC (2025) Summary page 5.
- K222561: Align, Acuity Surgical Devices, LLC (2022) Summary page 5.

## Most influential descendants
- K254130: C.A. Medical Interbody Fusion System (2026), 0 descendants of its own

## Indications for use
The Tera 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 Tera 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 Tera 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/K251335
Methodology: https://510kreport.com/methodology