510(k) · Cleared

Cleared

Independence Spacer

K082252510(k) TraditionalCleared Nov 5, 200889-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

Globus Medical, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

Cleared on Nov 5, 2008 as substantially equivalent to K072970 (Globus Medical, Inc., 2008) after an 89-day review. Its family tree reaches back 1 generation to 2008. 1 of the 578 devices in its family, counting itself, has a Class I recall. 576 later devices descend from it.

Decided: Nov 5, 2008
Review: 89 days
Class: Class II
Product code: OVD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K072970 (2008). 576 later devices descend from it, 13 citing it directly. 1 of the 578 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK072970 Patriot SpacersGlobus Medical, Inc. · 2008
This deviceK082252 Independence SpacerGlobus Medical, Inc. · 2008
Descendant · cites it directly · 554 of its ownK103382 Intercontinental Plate-SpacerGlobus Medical, Inc. · 2011
Descendant · 2 generations on · 466 of its ownK131723 Coroent Single Tab SystemNuvasive, Inc. · 2013
Descendant · 2 generations on · 465 of its ownK140479 Coroent XL-F SystemNu Vasive, Incorporated · 2014
Descendant · 3 generations on · 396 of its ownK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
Descendant · 3 generations on · 390 of its ownK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016

Showing 5 of 576 descendants. See all descendants

Descendants cleared per year

2011high 84 (2024) · low 1 (2011)2026

Class I recalls in this family

K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 576 · See all

K103382Intercontinental Plate-SpacerGlobus Medical, Inc. · 2011 · cites it directly554descendants
K131723Coroent Single Tab SystemNuvasive, Inc. · 2013 · 2 generations on466descendants
K140479Coroent XL-F SystemNu Vasive, Incorporated · 2014 · 2 generations on465descendants
K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016 · 3 generations on396descendants
K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · 3 generations on390descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K072970	Patriot Spacers	Globus Medical, Inc.	2008	—
0 (this device)	K082252	Independence Spacer	Globus Medical, Inc.	2008	—
+1	K103382	Intercontinental Plate-Spacer	Globus Medical, Inc.	2011	—
+2	K131723	Coroent Single Tab System	Nuvasive, Inc.	2013	—
+2	K140479	Coroent XL-F System	Nu Vasive, Incorporated	2014	—
+3	K160051	NuVasive® Interfixated Interbody System	Nu Vasive, Incorporated	2016	—
+3	K153782	NuVasive® Lumbar Interbody Implants	Nu Vasive, Incorporated	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	4	0
2013	4	0
2014	4	0
2015	4	0
2016	19	0
2017	27	0
2018	29	0
2019	36	0
2020	56	0
2021	49	1
2022	61	0
2023	69	0
2024	84	0
2025	70	0
2026	59	0

FIG. 1 — Lineage of K082252, 2008–2026Source: 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.

1 device in this family has a Class I recall. 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 OVD device

#1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K072970	Patriot Spacers Summary page 1 …Device Name: INDEPENDENCE™ Spacer Classification: Product Code MAX. Class Il. 21 CFR §888.3080 Intervertebral body fusion device. Predicate(s): PATRIOT Lumbar Spacers (K072970) and other legally marketed devices. Device Description: The INDEPENDENCE™ Spacer is a stand-alone anterior lumbar interbody fu…	Globus Medical, Inc.	2008	—

Also cleared against K072970: 28 other devices →

What descends from it? (576)

See all 576

13 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K103382	Intercontinental Plate-Spacer	Globus Medical, Inc.	2011	554
K120101	Independence Spacer	Globus Medical, Inc.	2012	224
K143578	SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…	Globus Medical, Inc.	2016	210
K142498	MAGNIFY and MAGNIFY-S Spacers	Globus Medical, Inc.	2015	175
K132559	Monument Spacers	Globus Medical, Inc.	2013	166
K152022	SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…	Globus Medical, Inc.	2017	149
K160597	INDEPENDENCE MIS Spacers	Globus Medical, Inc.	2016	111
K170157	INDEPENDENCE® Spacers	Globus Medical, Inc.	2017	109
K203278	INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…	Globus Medical, Inc.	2021	35
K112561	Nuvasive Coroent NO-Profile System	Nuvasive, Inc.	2012	12

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K103382 (Globus Medical, Inc., 2011) has gone furthest, with 554 descendants of its own.
28 other devices also cite its predicate K072970.

How does its category compare?

All OVD devices

OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · OVD

10in 2025

2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVD

100in 2025

2007high 167 (2011) · low 78 (2012)2026

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

Recalls per year · OVD

1in 2025

2007high 4 (2013) · low 0 (2007)2026

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

Adverse event reports per year · OVD

50in 2025

2007high 221 (2021) · low 0 (2007)2025

MAUDE reports naming product code OVD, 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	2	—	0	0
2008	8	84	0	0
2009	3	152	0	2
2010	8	117	0	2
2011	9	167	0	6
2012	10	78	0	16
2013	11	137	4	17
2014	14	139	0	35
2015	12	166	0	43
2016	13	127	1	55
2017	12	127	0	72
2018	14	126	0	112
2019	12	91	0	171
2020	14	91	0	203
2021	7	108	1	221
2022	14	133	1	74
2023	12	92	0	67
2024	12	110	0	92
2025	10	100	1	50
2026	8	93	1	—

What is it indicated for?

The INDEPENDENCE™ Spacer is a stand-alone interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The INDEPENDENCE™ Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws which accompany the implant.

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/K082252 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082252: Independence Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082252

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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