# K073274: Spinal Sphere System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine
- Decided: Mar 17, 2008 after 117 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). 2 ancestors in all.
No later device cites it as a predicate yet.
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.
- K060415: Modification to: Satellite Spinal System, Medtronic Sofamor Danek (2007) Summary page 2.

## Indications for use
The Spinal Sphere System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. Properly used, this internal fixation device is intended and designed solely for holding bone parts in alignment while they heal. The Spinal Sphere System is intended to be used with bone graft. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. It is not intended for use in motion-sparing, non-fusion procedures.

Source page: https://510kreport.com/device/K073274
Methodology: https://510kreport.com/methodology