# K073105: Peek Spinal Spheres

- Pathway: 510(k) (Special)
- Applicant: Interbody Innovations, Llp
- Decided: Jan 3, 2008 after 62 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: 2 generations back to K051320 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062992: Spinal Spheres, Interbody Innovations, Llp (2007) Summary page 2.
- K060415: Modification to: Satellite Spinal System, Medtronic Sofamor Danek (2007) Summary page 2.

## 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/K073105
Methodology: https://510kreport.com/methodology