# K111484: Discovery

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Spine, LLC
- Decided: Sep 12, 2011 after 104 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: 10 generations back to K841189 (1984). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.

## Most influential descendants
- K210521: DEXA-C Cervical Interbody System (2021), 0 descendants of its own

## Indications for use
The DISCOVERY is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DODD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDID is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

Source page: https://510kreport.com/device/K111484
Methodology: https://510kreport.com/methodology