510(k) · Decided

Decided

Spinal Sphere System

K073274510(k) TraditionalDecided Mar 17, 2008117-day reviewClass III

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

Life Spine · NVR Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

Cleared on Mar 17, 2008 as substantially equivalent to K051320 (Medtronic Sofamor Danek, 2005) and 1 other predicate after a 117-day review. Its family tree reaches back 2 generations to 2005.

Decided: Mar 17, 2008
Review: 117 days
Class: Class III
Product code: NVR
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K051320 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK051320 Satellite Spinal SystemMedtronic Sofamor Danek · 2005 · Recalled
1 generation backK060415 Modification to: Satellite Spinal SystemMedtronic Sofamor Danek · 2007
This deviceK073274 Spinal Sphere SystemLife Spine · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K051320	Satellite Spinal System	Medtronic Sofamor Danek	2005	2
−1	K060415	Modification to: Satellite Spinal System	Medtronic Sofamor Danek	2007	—
0 (this device)	K073274	Spinal Sphere System	Life Spine	2008	—

FIG. 1 — Lineage of K073274, 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 …cation Name: Intervertebral Fusion Device With Bone Graft, Solid- Sphere, Lumbar Product Code: NVR Predicate Device: Satellite™ Spinal System (Medtronic Sofamor Danek, K051320 and K060415) Device Description: The Spinal Sphere System consists of spheres manufactured from either CoCrMo or PEEK- OPTIMA.…	Medtronic Sofamor Danek	2005	2
*	K060415	Modification to: Satellite Spinal System Summary page 2 …Intervertebral Fusion Device With Bone Graft, Solid- Sphere, Lumbar Product Code: NVR Predicate Device: Satellite™ Spinal System (Medtronic Sofamor Danek, K051320 and K060415) Device Description: The Spinal Sphere System consists of spheres manufactured from either CoCrMo or PEEK- OPTIMA. The device m…	Medtronic Sofamor Danek	2007	—

Also cleared against K051320: 3 other devices →

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?

The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
1 of the 2 ancestors has a recall of any class.
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. 2008, 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 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. Properly used, this internal fixation device is intended and designed solely for holding bone parts in alignment while they heal. The Spinal Sphere System is intended to be used with bone graft. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. It is not intended for use in motion-sparing, non-fusion procedures.

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/K073274 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073274: Spinal 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/K073274

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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