510(k) · Cleared

Cleared

ACRON™ TLIF System

K171151510(k) TraditionalCleared Apr 27, 2018372-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

Spinemed Ges.M.B.H · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Apr 27, 2018 as substantially equivalent to K071795 (Nuvasive, Inc., 2007) after a 372-day review. Its family tree reaches back 2 generations to 2007.

Decided: Apr 27, 2018
Review: 372 days
Class: Class II
Product code: MAX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K071922 (2007). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK071922 Interplate Interbody Fusion Device, Models C, CGC, L and LGCRsb Spine, LLC · 2007
1 generation backK071795 Nuvasive Coroent SystemNuvasive, Inc. · 2007
This deviceK171151 ACRON™ TLIF SystemSpinemed Ges.M.B.H · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K071922	Interplate Interbody Fusion Device, Models C, CGC, L and LGC	Rsb Spine, LLC	2007	—
−1	K071795	Nuvasive Coroent System	Nuvasive, Inc.	2007	—
0 (this device)	K171151	ACRON™ TLIF System	Spinemed Ges.M.B.H	2018	—

FIG. 1 — Lineage of K171151, 2007–2018Source: 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.

Planning a device in MAX? 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? (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
*	K071795	Nuvasive Coroent System Summary page 4 …ced by NuVasive, Inc, as shown in Table 1-1. Predicate 510(k) Number Device Manufacturer Primary K071795 NuVasive CoRoent System NuVasive, Inc Reference K141665 NuVasive CoRoent System…	Nuvasive, Inc.	2007	—
†	K141665	NuVasive CoRoent System	Nuvasive, Inc.	2015	—

Also cleared against K071795: 41 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
None of the 2 ancestors has a recall.
41 other devices also cite its predicate K071795.

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. 2018, 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?

The ACRON™ TLIF System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ACRON™ TLIF System is to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K171151 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171151: ACRON™ TLIF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171151

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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