# K171075: Calix-C Cervical Interbody Spacer

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Aug 1, 2017 after 112 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: 16 generations back to K003155 (2001). 196 ancestors in all.
15 later devices descend from it; 5 cite it directly.
0 of 212 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112036: Calix PC Spinal Implant System, X-Spine Systems, Inc. (2011) Summary page 5.
- K143578: SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer, Globus Medical, Inc. (2016) Summary page 5.
- K160528: ANATOMIC PEEK PTC Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 5.
- K152532: AERO -C Cervical Cage System, Stryker Spine (2015) Summary page 5.
- K151064: Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System, Biomet Spine (2015) Summary page 5.

## Most influential descendants
- K202398: Ti3Z Cervical Interbody System (2021), 9 descendants of its own
- K202305: Zavation IBF System (2020), 9 descendants of its own
- K221049: Zavation VariSync Plate System and VariSync Spacer System (2022), 6 descendants of its own
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own
- K212811: Ti3Z Lumbar Interbody System (2022), 3 descendants of its own

## Indications for use
The Calix-C™ Cervical Interbody Spacer is intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with the Calix-C™ Cervical Interbody Spacer. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., posterior cervical screw and rod systems and anterior cervical plate systems).

Source page: https://510kreport.com/device/K171075
Methodology: https://510kreport.com/methodology