# K063139: Spinal Stabilizing Sphere System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine
- Decided: Apr 4, 2007 after 170 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.
No later device cites it as a predicate yet.
0 of 2 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 Spinal Sphere: named in the summary without a submission number
- (no number) Fernstrom SKF Ball: named in the summary without a submission number

## Indications for use
The Spinal Stabilizing 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. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Stabilizing Sphere System is intended to be used with bone graft.

Source page: https://510kreport.com/device/K063139
Methodology: https://510kreport.com/methodology