510(k) · Cleared

Cleared

Spine Scope, Model 2180

K011454510(k) TraditionalCleared Dec 13, 2001216-day reviewClass II21 CFR 888.1100

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

Cleared on Dec 13, 2001 after a 216-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 40 later devices descend from it.

Decided: Dec 13, 2001
Review: 216 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 0

40 later devices descend from it, 3 citing it directly.

This deviceK011454 Spine Scope, Model 2180Clarus Medical, LLC · 2001
Descendant · cites it directly · 20 of its ownK082841 Spinal ForaminoscopeBlazejewski Medi-Tech GmbH · 2009
Descendant · cites it directly · 18 of its ownK040424 Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous…Clarus Medical, LLC · 2004 · Recalled
Descendant · cites it directly · 17 of its ownK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
Descendant · 2 generations on · 14 of its ownK130778 Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH · 2014
Descendant · 2 generations on · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2004high 10 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 40 · See all

K082841Spinal ForaminoscopeBlazejewski Medi-Tech GmbH · 2009 · cites it directly20descendants
K040424Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model…Clarus Medical, LLC · 2004 · cites it directly18descendants
K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · cites it directly17descendants
K130778Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH · 2014 · 2 generations on14descendants
K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · 2 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011454	Spine Scope, Model 2180	Clarus Medical, LLC	2001	—
+1	K082841	Spinal Foraminoscope	Blazejewski Medi-Tech GmbH	2009	—
+1	K040424	Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy…	Clarus Medical, LLC	2004	1
+1	K040919	Nucleotome Probe Set, Model 21200	Clarus Medical, LLC	2004	1
+2	K130778	Discoscopes, Cervical Endoscopes	Rz Medizintechnik GmbH	2014	—
+2	K062038	X-Sten Mild Tool Kit, Model MTK-0001	X-Sten Corp.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2006	1	0
2009	3	0
2010	1	0
2012	1	0
2013	1	0
2014	2	0
2018	3	0
2019	1	0
2020	1	0
2021	1	0
2023	1	0
2024	5	0
2025	10	0
2026	7	0

FIG. 1 — Lineage of K011454, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRX? 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 HRX device

#1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
#2 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (40)

See all 40

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

Number	Device	Applicant	Decided	Descendants
K082841	Spinal Foraminoscope	Blazejewski Medi-Tech GmbH	2009	20
K040424	Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model…	Clarus Medical, LLC	2004	18
K040919	Nucleotome Probe Set, Model 21200	Clarus Medical, LLC	2004	17

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?

Of its descendants, K082841 (Blazejewski Medi-Tech GmbH, 2009) has gone furthest, with 20 descendants of its own.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007high 249 (2023) · low 45 (2019)2026

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

Recalls per year · HRX

1in 2024

2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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	89	3	421
2008	9	115	13	441
2009	11	139	23	558
2010	9	114	12	612
2011	3	84	6	631
2012	11	102	0	778
2013	12	90	4	678
2014	9	140	0	802
2015	4	132	7	763
2016	8	89	0	469
2017	4	97	0	934
2018	12	101	1	1,581
2019	12	45	0	1,676
2020	7	141	0	1,706
2021	7	57	3	1,908
2022	3	89	0	1,406
2023	4	249	0	1,852
2024	6	110	1	2,427
2025	9	107	0	2,076
2026	7	217	0	—

https://510kreport.com/device/K011454 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011454: Spine Scope, Model 2180.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011454

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026