510(k) · Cleared

Cleared

Bright Spine Galileo Spinal Spacer System

K102449510(k) TraditionalCleared Feb 11, 2011168-day reviewClass II21 CFR 888.3080

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

Bright Spine, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Feb 11, 2011 as substantially equivalent to K081730 (Alphatec Spine, Inc., 2008) after a 168-day review. Its family tree reaches back 1 generation to 2008.

Decided: Feb 11, 2011
Review: 168 days
Class: Class II
Product code: ODP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K081730 (2008). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK081730 Novel Cervical Spinal Spacer SystemAlphatec Spine, Inc. · 2008
This deviceK102449 Bright Spine Galileo Spinal Spacer SystemBright Spine, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K081730	Novel Cervical Spinal Spacer System	Alphatec Spine, Inc.	2008	—
0 (this device)	K102449	Bright Spine Galileo Spinal Spacer System	Bright Spine, Inc.	2011	—

FIG. 1 — Lineage of K102449, 2008–2011Source: 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 ODP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new ODP device

#1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K081730	Novel Cervical Spinal Spacer System Summary page 1 …21 CFR 888.3080 (ODP) Predicate Device: Alphatec Spine, Inc. Novel® Spinal Spacer System K081730 Device Description: The Bright Spine Galileo"' Spinal Spacer System…	Alphatec Spine, Inc.	2008	—

Also cleared against K081730: 15 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?

Its one ancestor has no recall.
15 other devices also cite its predicate K081730.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · ODP

57in 2025

2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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	0	—	0	0
2008	8	89	0	2
2009	12	127	1	21
2010	9	151	0	54
2011	25	113	1	38
2012	17	93	0	92
2013	18	187	1	78
2014	26	118	0	43
2015	24	180	0	51
2016	17	112	0	37
2017	33	104	0	39
2018	25	133	0	51
2019	22	92	0	141
2020	14	89	1	86
2021	18	121	0	161
2022	12	92	0	50
2023	34	165	0	36
2024	10	76	0	55
2025	11	87	2	57
2026	19	117	0	—

What is it indicated for?

When used as a cervical intervertebral body fusion device, the GalileoTM Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to TI) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous hone graft. These patients should have had six months of non-operative treatment. The GalileoTM Spinal Spacer System is to be used with a supplemental fixation system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102449 · printed Nov 3, 2026

Cite this page

510(k) Report. “K102449: Bright Spine Galileo Spinal Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102449

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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