510(k) · Cleared

Cleared

Interplate Interbody Fusion Device, Models C, CGC, L and LGC

K071922510(k) TraditionalCleared Sep 18, 200768-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

Rsb Spine, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

Cleared on Sep 18, 2007 after a 68-day review. The FDA summary names no predicate by number. 1 of the 1,222 devices in its family, counting itself, has a Class I recall. 1,221 later devices descend from it.

Decided: Sep 18, 2007
Review: 68 days
Class: Class II
Product code: OVD
Recalls: None
Predicates: 0

1,221 later devices descend from it, 5 citing it directly. 1 of the 1,222 devices in this family, counting this one, has a Class I recall.

This deviceK071922 Interplate Interbody Fusion Device, Models C, CGC, L and LGCRsb Spine, LLC · 2007
Descendant · cites it directly · 1,122 of its ownK071795 Nuvasive Coroent SystemNuvasive, Inc. · 2007
Descendant · 2 generations on · 933 of its ownK082128 Depuy Spine Lateral Cage SystemDepuy Spine · 2008
Descendant · 3 generations on · 932 of its ownK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
Descendant · 2 generations on · 921 of its ownK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
Descendant · 3 generations on · 869 of its ownK102293 Caliber SpacerGlobus Medical, Inc. · 2011

Showing 5 of 1,221 descendants. See all descendants

Descendants cleared per year

2007high 104 (2024) · low 1 (2007)2026

Class I recalls in this family

K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 1,221 · See all

K071795Nuvasive Coroent SystemNuvasive, Inc. · 2007 · cites it directly1,122descendants
K082128Depuy Spine Lateral Cage SystemDepuy Spine · 2008 · 2 generations on933descendants
K090899Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009 · 3 generations on932descendants
K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009 · 2 generations on921descendants
K102293Caliber SpacerGlobus Medical, Inc. · 2011 · 3 generations on869descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K071922	Interplate Interbody Fusion Device, Models C, CGC, L and LGC	Rsb Spine, LLC	2007	—
+1	K071795	Nuvasive Coroent System	Nuvasive, Inc.	2007	—
+2	K082128	Depuy Spine Lateral Cage System	Depuy Spine	2008	—
+3	K090899	Depuy Spine Lateral System	Depuy Spine, Inc.	2009	—
+2	K093242	Patriot Transcontinental Llif Spacer	Globus Medical, Inc.	2009	—
+3	K102293	Caliber Spacer	Globus Medical, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	5	0
2009	6	0
2010	10	0
2011	17	0
2012	28	0
2013	43	0
2014	57	0
2015	57	0
2016	78	0
2017	100	0
2018	99	0
2019	90	0
2020	99	0
2021	83	1
2022	84	0
2023	102	0
2024	104	0
2025	82	0
2026	76	0

FIG. 1 — Lineage of K071922, 2007–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (1,221)

See all 1,221

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

Number	Device	Applicant	Decided	Descendants
K071795	Nuvasive Coroent System	Nuvasive, Inc.	2007	1,122
K081501	Solitaire Anterior Spinal System	Biomet Spine	2008	834
K080673	Interfuse Intervertebral Body Fusion Device	Vertebral Technologies, Inc.	2008	103
K092540	C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody Spacer	Rsb Spine, LLC	2010	45
K133827	A-Link Z	Osteo Vasive, LLC	2014	26

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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K071795 (Nuvasive, Inc., 2007) has gone furthest, with 1,122 descendants of its own.

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. 2007, 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 InterPlate is indicated for anterior screw fixation or intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The InterPlate C and CGC Systems are intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration…

Read the full statement (178 words)

The InterPlate C and CGC Systems are intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.

The InterPlate L and LGC Systems are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade | spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

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/K071922 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071922: Interplate Interbody Fusion Device, Models C, CGC, L and LGC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071922

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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