# K051027: Stalif TT

- Pathway: 510(k) (Traditional)
- Applicant: Surgicraft, Ltd.
- Decided: Jun 29, 2005 after 68 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
No predicates in its family tree.
908 later devices descend from it; 2 cite it directly.
1 of 909 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DePuy AcroMed Stackable Cage System: named in the summary without a submission number
- (no number) Interpore Cross International GEO Structure: named in the summary without a submission number

## 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 or partial destruction by tumor or fracture/trauma leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is intended for use as a vertebral body replacement or partial replacement in the thoracolumbar spine (from T9 to L5). The STALIFTM TT device may be used with bone graft.

Source page: https://510kreport.com/device/K051027
Methodology: https://510kreport.com/methodology