# K173832: InTice™-C Porous Ti Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: May 17, 2018 after 150 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 17 generations back to K003155 (2001). 227 ancestors in all.
No later device cites it as a predicate yet.
1 of 228 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171075: Calix-C Cervical Interbody Spacer, X-Spine Systems, Inc. (2017) Summary page 5.
- K162944: Irix-C Cervical Integrated Fusion System, X-Spine Systems, Inc. (2016) Summary page 5.
- K161485: Nanovis Intervertebral Body Fusion System and Forticore (R), Nanovis, LLC (2016) Summary page 5.

## Recalls of this device
- Sep 30, 2020 · Class III · Z-0429-2021: Cervical Implants contain a label that incorrectly identifies the grade of titanium used.

## Indications for use
The InTice™-C Porous Ti Cervical Interbody System 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 non-operative treatment prior to treatment with the InTice™-C Porous Ti Cervical Interbody System. 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/K173832
Methodology: https://510kreport.com/methodology