# K240889: ARTFX Lumbar PEEK Cages

- Pathway: 510(k) (Traditional)
- Applicant: Artfx Medical
- Decided: Oct 2, 2024 after 184 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: 22 generations back to K841189 (1984). 215 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152011: Lucent Intervertebral Body Fusion Device, Spinal Elements, Inc. (2016) Summary page 6.
- K180078: Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System, Innovasis, Inc. (2018) Summary page 6.

## Most influential descendants
- K252781: MSFX Mikron Peek Cages (2025), 1 descendant of its own
- K252686: EffortMed PEEK Cages & Corpectomy Cages (2025), 1 descendant of its own
- K260850: Osteomni Spinal Cages System (2026), 0 descendants of its own
- K260340: HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC Biologics Osteopoint Lumbar Peek Cages (2026), 0 descendants of its own

## Indications for use
The ARTFX Lumbar PEEK Cages are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment. The devices are designed to be used with supplemental fixation and autograft/autologous bone grafts to facilitate fusion for each spinal region.

Source page: https://510kreport.com/device/K240889
Methodology: https://510kreport.com/methodology