# K120819: Stalif C

- Pathway: 510(k) (Special)
- Applicant: Centinel Spine, Inc.
- Decided: Aug 31, 2012 after 165 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: 11 generations back to K841189 (1984). 43 ancestors in all.
206 later devices descend from it; 11 cite it directly.
0 of 250 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072415: Stalif (TM) C, Surgicraft, Ltd. (2008) Summary page 2.
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 2.
- K071833: Mosaic Devices, Spinal Elements, Inc. (2007) Summary page 2.
- P000028: Affinity (TM) Cage System, Medtronic Sofamor Danek USA, Inc. (2002) Summary page 2.

## Most influential descendants
- K142940: Endoskeleton TCS System (2015), 111 descendants of its own
- K151596: Endoskeleton TCS Interbody Fusion Device (2015), 110 descendants of its own
- K132029: Vault-C Intervertebral Body Fusion Device (2013), 108 descendants of its own
- K153122: Endoskeleton (r) TCS System (2015), 106 descendants of its own
- K173535: Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device (2018), 105 descendants of its own

## Indications for use
The STALIF C® is 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 from levels C2 to TI for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin wit degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. STALIF CC is intended to be used at one level. 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/K120819
Methodology: https://510kreport.com/methodology