# K072415: Stalif (TM) C

- Pathway: 510(k) (Abbreviated)
- Applicant: Surgicraft, Ltd.
- Decided: Jan 25, 2008 after 150 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: 1 generation back to P980048 (2001). 3 ancestors in all.
948 later devices descend from it; 13 cite it directly.
1 of 952 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.
- P000028: Affinity (TM) Cage System, Medtronic Sofamor Danek USA, Inc. (2002) Summary page 1.
- K071833: Mosaic Devices, Spinal Elements, Inc. (2007). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K073109: Stalif TT Intervertebral Body Fusion System (2008), 907 descendants of its own
- K083475: Lucent Magnum (2009), 834 descendants of its own
- K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device (2008), 753 descendants of its own
- K100043: Coroent XLR Standalone System (2010), 744 descendants of its own
- K123045: Brigade Standalone System (2013), 696 descendants of its own

## Indications for use
The STALIF C is intended to be used as an. intervertebral body fusion cage as a stand alone system used with the 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 Tl 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 to facilitate fusion. STALIF™ C 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/K072415
Methodology: https://510kreport.com/methodology