# K121320: C7 Anterior Cervical Intervertebral Fusion Cage

- Pathway: 510(k) (Traditional)
- Applicant: Medyssey Co, Ltd.
- Decided: Aug 10, 2012 after 100 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: 8 generations back to K010530 (2001). 42 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090887: Orio-C Cervical, Orio-TL Tlif, Orio-PL Plif, Orio-AL Alif Intervedrtebral Body Fusion Cages, SpineCraft (2009) Summary page 2.
- K092904: Pathway Ivb/VBR, Custom Spine, Inc. (2009) Summary page 1.
- K092336: C-Thru Spinal System, Ebi, L.P. (2009) Summary page 1.

## Most influential descendants
- K122801: Providence Cervical Cage (2013), 1 descendant of its own
- K161642: CAVUX™ Cervical Cage (2016), 0 descendants of its own

## Indications for use
The C7 Anterior Cervical Intervertebral Fusion Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. C7 Anterior Cervical Intervertebral Fusion Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. C7 Anterior Cervical Intervertebral Fusion Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K121320
Methodology: https://510kreport.com/methodology