# K240893: ARTFX MEDICAL Cervical PEEK Cages

- Pathway: 510(k) (Traditional)
- Applicant: Artfx Medical
- Decided: Jun 28, 2024 after 88 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 27 generations back to K841189 (1984). 499 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 504 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212266: FIX-C PEEK Anterior Cervical Interbody System, Jeil Medical Corporation (2021) Summary page 5.
- K212358: Romero Cervical Cage, Spineup, Inc. (2022) Summary page 5.

## 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
ARTFX MEDICAL Cervical PEEK Cages are made to be implanted into the appropriate vertebral section to help provide stability for spinal fusion after a diseased cervical disc producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of non-operative treatment. Cervical PEEK Cages are indicated for use in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1 ). DOD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Cervical PEEK Cages facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and packed with autogenous bone. ARTFX MEDICAL Cervical PEEK Cages are to be used with supplemental fixation.

Source page: https://510kreport.com/device/K240893
Methodology: https://510kreport.com/methodology