# K103729: Infill Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Pinnacle Spine Group, LLC
- Decided: Apr 18, 2011 after 117 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: 10 generations back to K841189 (1984). 19 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.
- K093242: Patriot Transcontinental Llif Spacer, Globus Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K121733: Infill Intervertebral Body Fusion Device (2012), 21 descendants of its own
- K130461: Stalif X (2013), 13 descendants of its own
- K173347: STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX (2018), 12 descendants of its own
- K124012: Infill Oblique Tlif Device (2013), 6 descendants of its own
- 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

## Indications for use
InFill is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill is designed for use with autogenous bone graft to facilitate fusion. InFill 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 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/K103729
Methodology: https://510kreport.com/methodology