# K181548: Pantheon Spinal Pontus Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Pantheon Spinal
- Decided: Dec 16, 2019 after 552 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: 1 generation back to K113781 (2013). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113781: Pantheon Spinal Ibfd System, Pantheon Spinal (2013) Summary page 5.
- K170572: Summit Spine Yellowstone Lumbar Interbody Fusion System, Summit Spine (2017) Summary page 5.

## Most influential descendants
- K203003: Pantheon IBFD (2021), 0 descendants of its own

## Indications for use
The Pantheon Spinal Pontus Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. Pantheon Spinal Pontus Interbody Fusion Device is designed for use with autogenous bone graft to facilitate fusion. Pantheon Spinal Pontus 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 1 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. Pantheon Spinal Pontus 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/K181548
Methodology: https://510kreport.com/methodology