510(k) · Cleared

Cleared

Lucent

K071724510(k) TraditionalCleared Nov 9, 2007137-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 Nov 9, 2007 after a 137-day review. The FDA summary names no predicate by number. 1 of the 1,175 devices in its family, counting itself, has a Class I recall. 1,174 later devices descend from it.

Decided: Nov 9, 2007
Review: 137 days
Class: Class II
Product code: MAX
Recalls: None
Predicates: 0

1,174 later devices descend from it, 39 citing it directly. 1 of the 1,175 devices in this family, counting this one, has a Class I recall.

This deviceK071724 LucentSpinal Elements, Inc. · 2007
Descendant · cites it directly · 834 of its ownK083475 Lucent MagnumSpinal Elements, Inc. · 2009
Descendant · cites it directly · 788 of its ownK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
Descendant · cites it directly · 762 of its ownK111512 Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc. · 2011
Descendant · 2 generations on · 761 of its ownK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
Descendant · 2 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010

Showing 5 of 1,174 descendants. See all descendants

Descendants cleared per year

2008high 103 (2023) · low 4 (2008)2026

Class I recalls in this family

K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 1,174 · See all

K083475Lucent MagnumSpinal Elements, Inc. · 2009 · cites it directly834descendants
K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc. · 2008 · cites it directly788descendants
K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc. · 2011 · cites it directly762descendants
K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on761descendants
K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 2 generations on744descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K071724	Lucent	Spinal Elements, Inc.	2007	—
+1	K083475	Lucent Magnum	Spinal Elements, Inc.	2009	—
+1	K071983	Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace…	Aesculap Implant Systems, Inc.	2008	1
+1	K111512	Bonebac T-Plif Intervertebral Body Fusion Device System	Thompson Mis, Inc.	2011	—
+2	K120368	Capstone Control Spinal System	Medtronic Sofamor Danek USA, Inc.	2012	—
+2	K100043	Coroent XLR Standalone System	Nuvasive, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	4	0
2009	5	0
2010	7	0
2011	13	0
2012	20	0
2013	22	0
2014	51	0
2015	57	0
2016	73	0
2017	99	0
2018	92	0
2019	95	0
2020	100	0
2021	86	1
2022	84	0
2023	103	0
2024	103	0
2025	82	0
2026	78	0

FIG. 1 — Lineage of K071724, 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

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (1,174)

See all 1,174

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

Number	Device	Applicant	Decided	Descendants
K083475	Lucent Magnum	Spinal Elements, Inc.	2009	834
K071983	Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space	Aesculap Implant Systems, Inc.	2008	788
K111512	Bonebac T-Plif Intervertebral Body Fusion Device System	Thompson Mis, Inc.	2011	762
K081968	Modification to Lucent	Spinal Elements, Inc.	2008	716
K110632	Lucent or Lucent Magnum	Spinal Elements, Inc.	2012	694
K090566	Pathway Avid	Custom Spine, Inc.	2009	639
K122967	Lucent	Spinal Elements, Inc.	2013	615
K131082	Interform Interbody Cage System	Next Orthosurgical	2013	595
K113561	TM Ardis Interbody System TM Ardis Interbody System Instrumenation	Zimmer Trabecular Metal Technology	2012	476
K141405	Mobis II ST Spinal Implant	Signus Medizintechnik GmbH	2014	461

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, K083475 (Spinal Elements, Inc., 2009) has gone furthest, with 834 descendants of its own.

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. 2007, 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 (268 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 intervertebralbody 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 ihvolved 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/K071724 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071724: Lucent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071724

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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