510(k) · Decided
Recalled · 2007Satellite Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · NVR Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
Cleared on Sep 9, 2005 after a 112-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 9, 2005
- Review
- 112 days
- Class
- Class III
- Product code
- NVR
- Recalls
- 2
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK051320 Satellite Spinal SystemMedtronic Sofamor Danek · 2005
- Descendant · cites it directly · 2 of its ownK060415 Modification to: Satellite Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · cites it directly · 1 of its ownK062992 Spinal SpheresInterbody Innovations, Llp · 2007
- Descendant · cites it directly · 0 of its ownK073274 Spinal Sphere SystemLife Spine · 2008
- Descendant · 2 generations on · 0 of its ownK073105 Peek Spinal SpheresInterbody Innovations, Llp · 2008
- Descendant · cites it directly · 0 of its ownK063139 Spinal Stabilizing Sphere SystemBiomet Spine · 2007
Most influential descendants
Showing 5 of 5 · See all- K060415Modification to: Satellite Spinal SystemMedtronic Sofamor Danek · 2007 · cites it directly2descendants
- K062992Spinal SpheresInterbody Innovations, Llp · 2007 · cites it directly1descendant
- K073274Spinal Sphere SystemLife Spine · 2008 · cites it directly0descendants
- K073105Peek Spinal SpheresInterbody Innovations, Llp · 2008 · 2 generations on0descendants
- K063139Spinal Stabilizing Sphere SystemBiomet Spine · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051320 | Satellite Spinal System | Medtronic Sofamor Danek | 2005 | — |
| +1 | K060415 | Modification to: Satellite Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +1 | K062992 | Spinal Spheres | Interbody Innovations, Llp | 2007 | — |
| +1 | K073274 | Spinal Sphere System | Life Spine | 2008 | — |
| +2 | K073105 | Peek Spinal Spheres | Interbody Innovations, Llp | 2008 | — |
| +1 | K063139 | Spinal Stabilizing Sphere System | Biomet Spine | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NVR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Harmon Spinal Sphere Named without a submission number |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 13, 2007 | Not classified | Z-0192-2008 | Labeling design | Surgical manual lacks information required as a condition of the 510(k) approval. |
| Jan 14, 2006 | Not classified | Z-1088-06 | Other | Device distribution without marketing clearance |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060415 (Medtronic Sofamor Danek, 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NVR devicesNVR Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NVR
2in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · NVR
298in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NVR
17in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NVR
1in 2021
MAUDE reports naming product code NVR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 298 | 17 | 4 |
| 2008 | 2 | — | 0 | 9 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K051320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051320: Satellite Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051320
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026