510(k) · Cleared

Recalled · Class II · 2016

Solitaire Anterior Spinal System

K081501510(k) TraditionalCleared Jul 2, 200834-day reviewClass II21 CFR 888.3080Recalls 1

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

Biomet Spine · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

Cleared on Jul 2, 2008 as substantially equivalent to K071922 (Rsb Spine, LLC, 2007) and 2 other predicates after a 34-day review. Its family tree reaches back 1 generation to 2003. 1 of the 838 devices in its family, counting itself, has a Class I recall. 834 later devices descend from it. It has been recalled once.

Decided: Jul 2, 2008
Review: 34 days
Class: Class II
Product code: OVD
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K022143 (2003). 3 ancestors in all. 834 later devices descend from it, 5 citing it directly. 1 of the 838 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK022143 Interpore Cross International Anterior Fixation Device (Afd)Interpore Cross Intl. · 2003
This deviceK081501 Solitaire Anterior Spinal SystemBiomet Spine · 2008
Descendant · cites it directly · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
Descendant · 2 generations on · 696 of its ownK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
Descendant · 3 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
Descendant · 4 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Descendant · 3 generations on · 465 of its ownK140479 Coroent XL-F SystemNu Vasive, Incorporated · 2014

Showing 5 of 834 descendants. See all descendants

Descendants cleared per year

2010high 92 (2024) · low 3 (2010)2026

Class I recalls in this family

K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 834 · See all

K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · cites it directly744descendants
K123045Brigade Standalone SystemNuvasive, Inc. · 2013 · 2 generations on696descendants
K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 3 generations on588descendants
K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 4 generations on479descendants
K140479Coroent XL-F SystemNu Vasive, Incorporated · 2014 · 3 generations on465descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K022143	Interpore Cross International Anterior Fixation Device (Afd)	Interpore Cross Intl.	2003	—
0 (this device)	K081501	Solitaire Anterior Spinal System	Biomet Spine	2008	—
+1	K100043	Coroent XLR Standalone System	Nuvasive, Inc.	2010	—
+2	K123045	Brigade Standalone System	Nuvasive, Inc.	2013	—
+3	K141665	NuVasive CoRoent System	Nuvasive, Inc.	2015	—
+4	K151472	NuVasive CoRoent Lumbar System	Nu Vasive, Incorporated	2015	—
+3	K140479	Coroent XL-F System	Nu Vasive, Incorporated	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	3	0
2011	4	0
2012	4	0
2013	5	0
2014	12	0
2015	24	0
2016	43	0
2017	54	0
2018	63	0
2019	70	0
2020	91	0
2021	70	1
2022	72	0
2023	85	0
2024	92	0
2025	76	0
2026	66	0

FIG. 1 — Lineage of K081501, 2003–2026Source: 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

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What was it cleared against? (3)

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
*	K071922	Interplate Interbody Fusion Device, Models C, CGC, L and LGC Summary page 2 …example of another predicate intervertebral body fusion device distributed for the similar indications include the InterPlate™ Interbody Fusion Device by RSB Spine, LLC (K071922) while the Solitaire™ Anterior Spinal System from Interpore Cross Intl and EBILP (K022143 & K062810) have similar design features…	Rsb Spine, LLC	2007	—
*	K022143	Interpore Cross International Anterior Fixation Device (Afd) Summary page 2 …indications include the InterPlate™ Interbody Fusion Device by RSB Spine, LLC (K071922) while the Solitaire™ Anterior Spinal System from Interpore Cross Intl and EBILP (K022143 & K062810) have similar design features. Based upon the mechanical testing, the Solitaire ~ Anterior Spinal System is substantial…	Interpore Cross Intl.	2003	—
*	K062810	Solitaire Anterior Spinal System Summary page 2 …ns include the InterPlate™ Interbody Fusion Device by RSB Spine, LLC (K071922) while the Solitaire™ Anterior Spinal System from Interpore Cross Intl and EBILP (K022143 & K062810) have similar design features. Based upon the mechanical testing, the Solitaire ~ Anterior Spinal System is substantially equival…	Ebi, L.P.	2006	—

Also cleared against K071922: 4 other devices →

What descends from it? (834)

See all 834

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

Number	Device	Applicant	Decided	Descendants
K100043	Coroent XLR Standalone System	Nuvasive, Inc.	2010	744
K092211	Chesapeake Spinal System	K2m, Inc.	2010	450
K120031	Chesapeake Spinal System	K2m, Inc.	2012	334
K093629	Solitaire and Solitaire Peek Anterior Spinal System	Biomet Spine	2010	143
K103369	Vault Alif System	Spinal USA	2011	10

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 12, 2016	Class II	Z-1253-2016	Mixed-up of materials/components	Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees.

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

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K100043 (Nuvasive, Inc., 2010) has gone furthest, with 744 descendants of its own.
4 other devices also cite its predicate K071922.

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?

Read the full statement (207 words)

The Solitaire Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

As an intervertebral body fusion device designed for use with autograft, the Solitaire Anterior Spinal System is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and 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/K081501 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081501: Solitaire Anterior Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081501

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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