# K213115: CHENA-C Spacer System

- Pathway: 510(k) (Special)
- Applicant: Kahtnu Surgical, Inc.
- Decided: Dec 6, 2021 after 70 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: 15 generations back to K003155 (2001). 142 ancestors in all.
No later device cites it as a predicate yet.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181140: Axis Chena Cervical PEEK Spacer System, Axis Orthopaedics (2018) Summary page 4.
- K173128: Alamo® C, Alliance Partners, LLC (2018) Summary page 5.

## Indications for use
The CHENA-C Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-TI. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The CHENA-C Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The CHENA-C Spacer is intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K213115
Methodology: https://510kreport.com/methodology