# K124012: Infill Oblique Tlif Device

- Pathway: 510(k) (Traditional)
- Applicant: Pinnacle Spine Group, LLC
- Decided: Jun 4, 2013 after 159 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 12 generations back to K841189 (1984). 23 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103729: Infill Intervertebral Body Fusion Device, Pinnacle Spine Group, LLC (2011) Summary page 1.
- K121733: Infill Intervertebral Body Fusion Device, Pinnacle Spine Group, LLC (2012) Summary page 1.
- K073669: Oria Natura Spacer, Choicespine, LP (2008) Summary page 1.
- K120918: Nuvasive Coroent Titanium System, Nuvasive, Inc. (2012) Summary page 1.

## Most influential descendants
- K133721: Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif Contour Oblique and the Infill 60 (2014), 5 descendants of its own
- K151184: InFill Interbody Fusion Devices (2015), 3 descendants of its own
- K152259: InFill Interbody Fusion Device (2015), 2 descendants of its own
- K150206: InFill Interbody Fusion Devices (2015), 2 descendants of its own
- K172349: InFill® Interbody Fusion Device (2017), 1 descendant of its own

## Indications for use
InFill™ TLIF Oblique is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ TLIF Oblique is designed for use with autogenous bone graft to facilitate fusion. InFill™ TLIF Oblique is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ TLIF Oblique is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K124012
Methodology: https://510kreport.com/methodology