# K062992: Spinal Spheres

- Pathway: 510(k) (Traditional)
- Applicant: Interbody Innovations, Llp
- Decided: Jul 27, 2007 after 298 days
- Product code: NVR (Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K051320 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051320: Satellite Spinal System, Medtronic Sofamor Danek (2005) Summary page 2.
- (no number) Harmon Spheres: named in the summary without a submission number

## Most influential descendants
- K073105: Peek Spinal Spheres (2008), 0 descendants of its own

## Indications for use
The Spinal Spheres are intended to be inserted between vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Spheres are intended to be used with bone graft.

Source page: https://510kreport.com/device/K062992
Methodology: https://510kreport.com/methodology