# K203003: Pantheon IBFD

- Pathway: 510(k) (Special)
- Applicant: Pantheon Spinal
- Decided: Jul 7, 2021 after 279 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: 26 generations back to K841189 (1984). 421 ancestors in all.
No later device cites it as a predicate yet.
1 of 422 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181548: Pantheon Spinal Pontus Interbody Fusion Device, Pantheon Spinal (2019) Summary page 4.
- K113781: Pantheon Spinal Ibfd System, Pantheon Spinal (2013) Summary page 4.
- K191581: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device, Titan Spine, Inc. (2020) Summary page 4.

## Indications for use
When used as an intervertebral fusion device, the Pantheon IBFD devices are intended for use as either one level or two contiguous levels in the lumbar spine from L2 to S1, for the treatment of 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 device is to be used in patients who are skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. The devices are intended for use with supplemental fixation cleared for use in the lumbar spine and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K203003
Methodology: https://510kreport.com/methodology