# K112036: Calix PC Spinal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Nov 8, 2011 after 113 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: 1 generation back to P980048 (2001). 3 ancestors in all.
775 later devices descend from it; 12 cite it directly.
1 of 779 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 1.
- K083637: Calix Spinal Implant System, X-Spine Systems, Inc. (2009) Summary page 1.

## Most influential descendants
- K110632: Lucent or Lucent Magnum (2012), 694 descendants of its own
- K122967: Lucent (2013), 615 descendants of its own
- K140319: Coroent TI-C System (2014), 590 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own

## Indications for use
When used as a vertebral body replacement, the X-spine Calix PC System is intended for use in the thoracic and/or thoracolumbar spine {T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The Calix device, when used as a vertebral body replacement, can be packed with either allograft or autograft. When used as an intervertebral body fusion device, the X-spine Calix PC System is intended for spinal fusion procedures at one level (C3-C7) 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 autogenous bone. Patients should receive 6 weeks non-operative treatment prior to treatment with the Calix intervertebral body fusion device. For all indications, this device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical, thoracic or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Source page: https://510kreport.com/device/K112036
Methodology: https://510kreport.com/methodology