# K211892: ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)

- Pathway: 510(k) (Traditional)
- Applicant: Arftx Medical, LLC
- Decided: Oct 6, 2022 after 472 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K841189 (1984). 64 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192117: Small VBR™, Ulrich GmbH & Co. KG (2019) Summary page 6.

## Most influential descendants
- K252686: EffortMed PEEK Cages & Corpectomy Cages (2025), 1 descendant of its own
- K260850: Osteomni Spinal Cages System (2026), 0 descendants of its own

## Indications for use
The ESPINAX CORPECTOMY CAGE is intended for use in skeletally mature patients in the cervical spine (C2-T1) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The DISTRACTANIA CORPECTOMY CAGE is intended for use in skeletally mature patients in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The ESPINAX and DISTRACTANIA CORPECTOMY CAGES are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion. The ESPINAX and DISTRACTANIA CORPECTOMY CAGES are intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material is optional.

Source page: https://510kreport.com/device/K211892
Methodology: https://510kreport.com/methodology