# K073109: Stalif TT Intervertebral Body Fusion System

- Pathway: 510(k) (Abbreviated)
- Applicant: Surgicraft, Ltd.
- Decided: Jun 4, 2008 after 215 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- 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: 10 generations back to K841189 (1984). 38 ancestors in all.
907 later devices descend from it; 32 cite it directly.
1 of 946 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080083: Intrepid Spinal System, Medtronic Sofamor Danek (2008). Cleared while this submission was under review Summary page 1.
- K051027: Stalif TT, Surgicraft, Ltd. (2005) Summary page 1.
- K041617: Stalif TT, Surgicraft, Ltd. (2004) Summary page 1.
- K072415: Stalif (TM) C, Surgicraft, Ltd. (2008). Cleared while this submission was under review Summary page 1.
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 1.

## Most influential descendants
- 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
- K120869: Anchor-L Lumbar Cage (2012), 638 descendants of its own

## Indications for use
The STALIF™ TT Intervertebral Body Fusion System is indicated for use with autogenous bonc graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Thesc patients should be skeletally mature and have had six months of non-operative treatment. Patienfs with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The STALIF™ TT is a stand alonc system intended to be used with the bone screws provided and requires no additional supplementary fixation systcms. The STALIF™ TT system may be used with bone grafling material (autograft only).

Source page: https://510kreport.com/device/K073109
Methodology: https://510kreport.com/methodology