510(k) · Decided

Decided

Spinal Spheres

K062992510(k) TraditionalDecided Jul 27, 2007298-day reviewClass III

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Interbody Innovations, Llp · NVR Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

Cleared on Jul 27, 2007 as substantially equivalent to K051320 (Medtronic Sofamor Danek, 2005) after a 298-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.

Decided: Jul 27, 2007
Review: 298 days
Class: Class III
Product code: NVR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K051320 (2005). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK051320 Satellite Spinal SystemMedtronic Sofamor Danek · 2005 · Recalled
This deviceK062992 Spinal SpheresInterbody Innovations, Llp · 2007
Descendant · cites it directly · 0 of its ownK073105 Peek Spinal SpheresInterbody Innovations, Llp · 2008

Most influential descendants

Showing 1 of 1 · See all

K073105Peek Spinal SpheresInterbody Innovations, Llp · 2008 · cites it directly0descendants

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)	K062992	Spinal Spheres	Interbody Innovations, Llp	2007	—
+1	K073105	Peek Spinal Spheres	Interbody Innovations, Llp	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K062992, 2005–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K051320	Satellite Spinal System Summary page 2 …usion, solid sphere Unclassified NVR This device is substantially equivalent to the Harmon Spheres (Pre- amendment - Austenal Company, NY) and Satellite Spinal System (K051320 — Sofamor Danek, Memphis, TN). They are the same material, design and indications. The Spinal Spheres consist of CoCrMo spheres…	Medtronic Sofamor Danek	2005	2
*	—	Harmon Spheres Named without a submission number			—

Also cleared against K051320: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073105	Peek Spinal Spheres	Interbody Innovations, Llp	2008	0

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.
Of its descendants, K073105 (Interbody Innovations, Llp, 2008) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K051320.

How does its category compare?

All NVR devices

NVR 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

2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NVR

298in 2007

2007high 298 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NVR

17in 2007

2007high 17 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NVR

1in 2021

2007high 9 (2008) · low 0 (2010)2025

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 Spheres are intended to be inserted between 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 Spheres are 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/K062992 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062992: Spinal Spheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062992

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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