510(k) · Cleared

Cleared

Modification to Lucent

K081968510(k) SpecialCleared Aug 5, 200826-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

Spinal Elements, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Aug 5, 2008 as substantially equivalent to K071724 (Spinal Elements, Inc., 2007) and 1 other predicate after a 26-day review. Its family tree reaches back 1 generation to 2007. 1 of the 719 devices in its family, counting itself, has a Class I recall. 716 later devices descend from it.

Decided: Aug 5, 2008
Review: 26 days
Class: Class II
Product code: MAX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K071724 (2007). 2 ancestors in all. 716 later devices descend from it, 12 citing it directly. 1 of the 719 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK071724 LucentSpinal Elements, Inc. · 2007
This deviceK081968 Modification to LucentSpinal Elements, Inc. · 2008
Descendant · cites it directly · 595 of its ownK131082 Interform Interbody Cage SystemNext Orthosurgical · 2013
Descendant · 2 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
Descendant · 3 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Descendant · cites it directly · 461 of its ownK141405 Mobis II ST Spinal ImplantSignus Medizintechnik GmbH · 2014
Descendant · 2 generations on · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled

Showing 5 of 716 descendants. See all descendants

Descendants cleared per year

2011high 92 (2024) · low 1 (2011)2026

Class I recalls in this family

K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 716 · See all

K131082Interform Interbody Cage SystemNext Orthosurgical · 2013 · cites it directly595descendants
K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 2 generations on588descendants
K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 3 generations on479descendants
K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH · 2014 · cites it directly461descendants
K150481Cascadia Interbody SystemK2m, Inc. · 2015 · 2 generations on459descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K071724	Lucent	Spinal Elements, Inc.	2007	—
0 (this device)	K081968	Modification to Lucent	Spinal Elements, Inc.	2008	—
+1	K131082	Interform Interbody Cage System	Next Orthosurgical	2013	—
+2	K141665	NuVasive CoRoent System	Nuvasive, Inc.	2015	—
+3	K151472	NuVasive CoRoent Lumbar System	Nu Vasive, Incorporated	2015	—
+1	K141405	Mobis II ST Spinal Implant	Signus Medizintechnik GmbH	2014	—
+2	K150481	Cascadia Interbody System	K2m, Inc.	2015	3

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2013	2	0
2014	6	0
2015	12	0
2016	28	0
2017	43	0
2018	47	0
2019	57	0
2020	77	0
2021	62	1
2022	68	0
2023	84	0
2024	92	0
2025	75	0
2026	61	0

FIG. 1 — Lineage of K081968, 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 MAX device

#1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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? (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
*	K071724	Lucent Summary page 2 …the Lucent device. Substantial Equivalence The Lucent device was shown to be substantially equivalent through comparison to predicate Spinal Elements devices: Lucent® (K071724) and Lucent® Magnum (K073348). Summary of Technological Characteristics The Lucent devices of this submission are identical to p…	Spinal Elements, Inc.	2007	—
*	K073348	Lucent Magnum Summary page 2 …ial Equivalence The Lucent device was shown to be substantially equivalent through comparison to predicate Spinal Elements devices: Lucent® (K071724) and Lucent® Magnum (K073348). Summary of Technological Characteristics The Lucent devices of this submission are identical to predicates in indications for…	Spinal Elements, Inc.	2007	—

Also cleared against K071724: 38 other devices →

What descends from it? (716)

See all 716

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

Number	Device	Applicant	Decided	Descendants
K131082	Interform Interbody Cage System	Next Orthosurgical	2013	595
K141405	Mobis II ST Spinal Implant	Signus Medizintechnik GmbH	2014	461
K152512	Half Dome Posterior Lumbar Interbody System	Astura Medical	2016	33
K111166	A-Wedge Anterior Interbody System (a-Wedge a.I.S.)	Spineworks, LLC	2011	23
K182877	HALF DOME Posterior Lumbar Interbody System	Astura Medical, LLC	2019	21
K170297	Tranquil Interbody System	Nexus Spine, LLC	2017	15
K142634	Biomet Spine Fusion System	Biomet Spine, LLC	2015	5
K123100	Intess Lumbar Cage	Kalitec Direct, LLC	2013	5
K151483	Biomet Spine Fusion System	Biomet Spine, LLC	2015	4
K223335	SIRION Lateral Lumbar Interbody System	Astura Medical	2023	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K131082 (Next Orthosurgical, 2013) has gone furthest, with 595 descendants of its own.
38 other devices also cite its predicate K071724.

How does its category compare?

All MAX devices

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

FDA decisions per year · MAX

29in 2025

2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, 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	7	86	0	12
2008	35	88	2	19
2009	31	102	9	90
2010	29	137	0	154
2011	49	98	3	201
2012	48	69	11 (1)	327
2013	58	102	0	380
2014	58	115	3	366
2015	53	113	1	524
2016	64	124	6	647
2017	76	116	1	596
2018	64	114	4	616
2019	60	131	1	699
2020	56	106	0	640
2021	53	109	0	622
2022	41	95	1	618
2023	30	87	0	576
2024	38	91	1	729
2025	29	85	5	811
2026	18	95	0	—

What is it indicated for?

When used as a vertebral body replacement: When used as a vertebral body replacement, the Lucent device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in…

Read the full statement (269 words)

When used as a vertebral body replacement:

When used as a vertebral body replacement, the Lucent device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

When used as an intervertebral body fusion device:

When used as an intervertebral body fusion device, the Lucent device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). This device is intended to be used with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Lucent device.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081968 · printed Nov 3, 2026

Cite this page

510(k) Report. “K081968: Modification to Lucent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K081968

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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