# K170119: Calix Lumbar Spinal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Sep 29, 2017 after 259 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K841189 (1984). 199 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 201 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131350: Calix Lumbar Spinal Implant System, X-Spine Systems, Inc. (2013) Summary page 5.
- K112014: Zyston Straight Spacer System, Biomet Spine (2011) Summary page 5.
- K160916: CoRoent® Ti-C System, Nu Vasive, Incorporated (2016) Summary page 5.

## Most influential descendants
- K203520: Blustone Synergy Interbody Fusion System (2021), 0 descendants of its own

## Recalls of this device
- Dec 19, 2018 · Class II · Z-0790-2019: This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration.

## Indications for use
The Calix® Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 – S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Source page: https://510kreport.com/device/K170119
Methodology: https://510kreport.com/methodology