# K092815: S-Lif Intervertebral Body Fusion Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Spinefrontier, Inc.
- Decided: Jun 30, 2010 after 289 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P950002 (1996). 6 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072289: Spinefrontier Dorado VBR, Spinefrontier, Inc. (2007) Summary page 1.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 1.

## Most influential descendants
- K111553: Spinefrontier Lumbar Ibf System (2011), 14 descendants of its own
- K160976: Altus Spine Interbody Fusion System (2017), 8 descendants of its own
- K170512: Altus Spine Titanium Interbody Fusion System (2017), 6 descendants of its own
- K142504: SpineFrontier Lumbar Interbody Fusion Device System (2015), 4 descendants of its own
- K201367: FlareHawk TiHawk9 Interbody Fusion System (2020), 2 descendants of its own

## Recalls of this device
- Aug 28, 2013 · Class II · Z-0274-2014: Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.
- May 24, 2013 · Class II · Z-1665-2013: The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.
- May 17, 2013 · Class II · Z-1664-2013: The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
- Aug 29, 2012 · Class II · Z-1932-2013: During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
- Aug 22, 2012 · Class II · Z-0417-2013: When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating th
- Dec 23, 2011 · Class II · Z-1565-2014: It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the s

## Indications for use
The S-LlF TM Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DIDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The SpineFrontier S-LIF TM Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation systemn(s) cleared for use in the lumbar spine. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Source page: https://510kreport.com/device/K092815
Methodology: https://510kreport.com/methodology