# K172349: InFill® Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Pinnacle Spine Group, LLC
- Decided: Dec 14, 2017 after 133 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: 16 generations back to K841189 (1984). 119 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152259: InFill Interbody Fusion Device, Pinnacle Spine Group, LLC (2015) Summary page 6.
- K150206: InFill Interbody Fusion Devices, Pinnacle Spine Group, LLC (2015) Summary page 6.
- K133721: Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif Contour Oblique and the Infill 60, Pinnacle Spine Group, LLC (2014) Summary page 6.
- K150321: EVOS Lumbar Interbody System, Cutting Edge Spine, LLC (2015) Summary page 6.

## Most influential descendants
- K202820: Australis Anterior Lumbar Cage System (2020), 0 descendants of its own

## Indications for use
InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device 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® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and lateral.

Source page: https://510kreport.com/device/K172349
Methodology: https://510kreport.com/methodology