# K041617: Stalif TT

- Pathway: 510(k) (Traditional)
- Applicant: Surgicraft, Ltd.
- Decided: Sep 8, 2004 after 85 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K841189 (1984). 4 ancestors in all.
929 later devices descend from it; 5 cite it directly.
1 of 934 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K001340: Stackable Cage System, Depuyacromed (2000) Summary page 1.
- K013382: Modification to: Stackable Cage System, Depuyacromed (2001) 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 STALIFTM TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction by tumor or fracture leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5). The STALIFTM TT device is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the STALIF TT device, include but are not limited to, DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M2, Isola, VSP, Moss Miami, TiMx, Monarch and Profile).

Source page: https://510kreport.com/device/K041617
Methodology: https://510kreport.com/methodology