510(k) · Cleared

Cleared

Nucleotome 3.5 MM Automated Percutaneous Lumbar

K923525510(k) TraditionalCleared Feb 9, 1993208-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

Surgical Dynamics, Inc. · HRX Arthroscope

Cleared on Feb 9, 1993 after a 208-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 31 later devices descend from it.

Decided: Feb 9, 1993
Review: 208 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 0

31 later devices descend from it, 4 citing it directly.

This deviceK923525 Nucleotome 3.5 MM Automated Percutaneous LumbarSurgical Dynamics, Inc. · 1993
Descendant · cites it directly · 28 of its ownK032473 Dekompressor Percutaneous Discectomy ProbeStryker Instruments · 2003 · 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 ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
Descendant · 3 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
Descendant · 4 generations on · 7 of its ownK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2003high 5 (2012) · low 0 (2005)2026

Most influential descendants

Showing 5 of 31 · See all

K032473Dekompressor Percutaneous Discectomy ProbeStryker Instruments · 2003 · cites it directly28descendants
K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · cites it directly17descendants
K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · 2 generations on14descendants
K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · 3 generations on13descendants
K180876DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K923525	Nucleotome 3.5 MM Automated Percutaneous Lumbar	Surgical Dynamics, Inc.	1993	—
+1	K032473	Dekompressor Percutaneous Discectomy Probe	Stryker Instruments	2003	3
+1	K040919	Nucleotome Probe Set, Model 21200	Clarus Medical, LLC	2004	1
+2	K062038	X-Sten Mild Tool Kit, Model MTK-0001	X-Sten Corp.	2006	—
+3	K093062	Vertos Medical Mild Device Kit	X-Sten Corp.	2010	—
+4	K180876	DTRAX Spinal System	Providence Medical Technology, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2006	1	0
2008	1	0
2009	4	0
2010	1	0
2011	1	0
2012	5	0
2013	2	0
2014	1	0
2018	2	0
2019	1	0
2021	1	0
2024	2	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K923525, 1993–2026Source: 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
#3 Held for the reportin the report

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K032473	Dekompressor Percutaneous Discectomy Probe	Stryker Instruments	2003	28
K040919	Nucleotome Probe Set, Model 21200	Clarus Medical, LLC	2004	17
K082194	Laurimed Percutaneous Discectomy System, Model FG-000002	Laurimed, LLC	2008	1
K092877	Indiscal Aspiration Device and Accessories	Baylis Medical Co., Inc.	2009	0

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, K032473 (Stryker Instruments, 2003) has gone furthest, with 28 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/K923525 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923525: Nucleotome 3.5 MM Automated Percutaneous Lumbar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923525

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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