# K250335: IVA & AEON Cervical and Lumbar Cage System

- Pathway: 510(k) (Traditional)
- Applicant: K&J Consulting
- Decided: Aug 29, 2025 after 205 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: 24 generations back to K841189 (1984). 511 ancestors in all.
No later device cites it as a predicate yet.
1 of 512 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212038: K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage, K&J Consulting Corporation (2021) Summary page 5.
- K232877: FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System, K&J Consulting Corporation (2023) Summary page 5.
- K191243: HEDRON Cervical Spacers, Globus Medical, Inc. (2019) Summary page 5.
- K172446: SPIRA-C Open Matrix Cervical Interbody, Camber Spine Technologies (2017) Summary page 5.
- K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 6.
- K210595: SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers, Camber Spine Technologies, LLC (2021) Summary page 6.

## Indications for use
IVA-C (ACIF): The IVA-C Cage 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 or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device 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. AEON-C (ACIF): The AEON-C Cage System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C Cage System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used. IVA-L (ALIF, PLIF, DLIF, TLIF) & AEON-L (ALIF): The IVA-L Cage System and AEON-L Cage System are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AEON-L Cage System is designed for use with or without the bone screws, depending on the surgeon’s discretion. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K250335
Methodology: https://510kreport.com/methodology