# K254130: C.A. Medical Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: C.A. Medical, LLC
- Decided: Jul 8, 2026 after 198 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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: 27 generations back to K841189 (1984). 700 ancestors in all.
No later device cites it as a predicate yet.
1 of 701 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110659: Medical Concepts Interbody Fusion System, Medical Concepts, Inc. (2011) Summary page 5.
- K251335: Tera Lumbar Interbody Fusion System (Various PNs), Acuity Surgical Devices, LLC (2025) Summary page 5.
- K251735: Stabilis SA Cervical Stand-Alone System (Various PNs), Acuity Surgical Devices, LLC (2025) Summary page 5.

## Indications for use
When used as a cervical intervertebral body fusion device, the C.A. Medical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T] disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. When used as a lumbar intervertebral body fusion device, the C.A. Medical Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade | spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K254130
Methodology: https://510kreport.com/methodology