# K150053: STALIF C; STALIF C-Ti

- Pathway: 510(k) (Traditional)
- Applicant: Centinel Spine, Inc.
- Decided: Jun 24, 2015 after 163 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 2 generations back to K130177 (2013). 2 ancestors in all.
273 later devices descend from it; 9 cite it directly.
0 of 276 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142079: Stalif Cti, Stalif C, Centinel Spine, Inc. (2014) Summary page 3.

## Most influential descendants
- K151939: COALITION Spacers (2016), 152 descendants of its own
- K152532: AERO -C Cervical Cage System (2015), 145 descendants of its own
- K171496: Tritanium C Anterior Cervical Cage (2017), 129 descendants of its own
- K152515: TOMCAT Cervical Spinal System (2015), 108 descendants of its own
- K180364: HD LifeSciences Cervical IBFD System (2018), 106 descendants of its own

## Indications for use
The STALIF C® and STALIF C-Ti™ devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

Source page: https://510kreport.com/device/K150053
Methodology: https://510kreport.com/methodology