# K112801: Ayers Rock Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: Qualgenix
- Decided: May 1, 2012 after 217 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: 3 generations back to P950002 (1996). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080588: Scient'x Tribeca VBR, Scient'X USA, Inc. (2008) Summary page 1.
- K091873: Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-S, Spineart (2009) Summary page 1.

## Most influential descendants
- K163265: Kepler II (2017), 0 descendants of its own
- K162694: Ayers Rock Cervical interbody fusion system (2017), 0 descendants of its own

## Indications for use
The Qualgenix Ayers Rock Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-Ti. DDID is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Qualgenix Ayers Rock Cervical Cage implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Qualgenix Ayers Rock Cervical Cage is to be used with supplemental fixation..

Source page: https://510kreport.com/device/K112801
Methodology: https://510kreport.com/methodology