# K251735: Stabilis SA Cervical Stand-Alone System (Various PNs)

- Pathway: 510(k) (Traditional)
- Applicant: Acuity Surgical Devices, LLC
- Decided: Jul 30, 2025 after 54 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 26 generations back to K841189 (1984). 606 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 608 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230639: Align Cervical Interbody Fusion System, Acuity Surgical Devices, LLC (2023) Summary page 5.
- K211417: F3D-C2 Cervical Stand-Alone System, Corelink, LLC (2022) Summary page 5.
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System, Nexxt Spine, LLC (2020) Summary page 5.
- K111272: Rhausler Plage Anterior Cervical Fusion System, Rhausler, Inc. (2011) Summary page 5.

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

## Indications for use
The Stabilis SA Cervical Stand-Alone 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 system is 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 Stabilis SA Cervical Stand-Alone 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. Stabilis SA Cervical Stand-Alone System cages may be used as a stand-alone device when two (2) vertebral body bone screws are used. Stabilis SA Cervical Stand-Alone System cages with four (4) screw holes may be used as a stand-alone device when at least two (2) vertebral body bone screws are utilized with one inferior and one superior screw trajectory on opposite sides of the cage. If the physician chooses to use Stabilis SA Cervical Stand-Alone System cages with fewer than two (2) screws, then an additional supplemental spinal fixation system cleared for use in the cervical spine must be used. Stabilis SA Cervical Stand-Alone System cages with four (4) screw holes may only be used at contiguous levels if at least two (2) vertebral body bone screws are utilized in each cage with one inferior and one superior screw trajectory on opposite sides of the cage, such that no more than two (2) vertebral body bone screws are implanted at the shared vertebral body with one inferior and one superior screw trajectory on opposite sides of the cages. Additionally, a cage with four (4) screw holes and a cage with two (2) screw holes can be implanted contiguously only if the cage with four (4) screw holes uses at least (2) vertebral body bone screws with one inferior screw on the left side of the cage and one superior screw on the right side of the cage.

Source page: https://510kreport.com/device/K251735
Methodology: https://510kreport.com/methodology