# K212266: FIX-C PEEK Anterior Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Dec 21, 2021 after 154 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: 14 generations back to K003155 (2001). 69 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120275: Synthes Acis/Vertebral Spacer CR, Synthes (Usa), LLC (2012) Summary page 5.

## Most influential descendants
- K240893: ARTFX MEDICAL Cervical PEEK Cages (2024), 4 descendants of its own
- 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 FIX-C PEEK Anterior Cervical Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the FIX-C PEEK Anterior Cervical Interbody System should be packed with autogenous bone graft and implanted via an anterior approach. The FIX-C PEEK Anterior Cervical Interbody System is intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K212266
Methodology: https://510kreport.com/methodology