510(k) · Decided
DecidedSpinal Stabilizing Sphere System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine · NVR Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
Cleared on Apr 4, 2007 as substantially equivalent to K051320 (Medtronic Sofamor Danek, 2005) after a 170-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Apr 4, 2007
- Review
- 170 days
- Class
- Class III
- Product code
- NVR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051320 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK051320 Satellite Spinal SystemMedtronic Sofamor Danek · 2005 · Recalled
- This deviceK063139 Spinal Stabilizing Sphere SystemBiomet Spine · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051320 | Satellite Spinal System | Medtronic Sofamor Danek | 2005 | 2 |
| 0 (this device) | K063139 | Spinal Stabilizing Sphere System | Biomet Spine | 2007 | — |
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? (3)
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 |
|---|---|---|---|
| * | K051320 | Satellite Spinal SystemSummary page 2…To Which Substantial Equivalence Is Claimed: Harmon Spinal Sphere- Preamendment (Austenal Company); Fernstrom SKF Ball- Preamendment (unknown); Satellite™ Spinal System- K051320 (Medtronic Sofamor Danek) Device Description: The Spinal Stabilizing Sphere System consists of two types of CoCrMo spheres (full… | 2005 |
| * | — | Harmon Spinal Sphere Named without a submission number | |
| * | — | Fernstrom SKF Ball Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K051320.
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. 2007, this device’s year, is highlighted.
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 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.
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/K063139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063139: Spinal Stabilizing Sphere System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063139
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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