# K051320: Satellite Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Sep 9, 2005 after 112 days
- Product code: NVR (Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar)
- Device class: 3
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Harmon Spinal Sphere: named in the summary without a submission number

## Most influential descendants
- K060415: Modification to: Satellite Spinal System (2007), 2 descendants of its own
- K062992: Spinal Spheres (2007), 1 descendant of its own
- K073274: Spinal Sphere System (2008), 0 descendants of its own
- K073105: Peek Spinal Spheres (2008), 0 descendants of its own
- K063139: Spinal Stabilizing Sphere System (2007), 0 descendants of its own

## Recalls of this device
- Sep 13, 2007 · Not classified · Z-0192-2008: Surgical manual lacks information required as a condition of the 510(k) approval.
- Jan 14, 2006 · Not classified · Z-1088-06: Device distribution without marketing clearance

## Indications for use
The SATELLITE™ Spinal 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 SATELLITE™ Spinal System is intended to be used with bone graft.

Source page: https://510kreport.com/device/K051320
Methodology: https://510kreport.com/methodology