510(k) · Cleared

Cleared

Perc-D Spinewand

K010811510(k) TraditionalCleared May 30, 200172-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 May 30, 2001 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 72 later devices descend from it.

Decided: May 30, 2001
Review: 72 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 0

72 later devices descend from it, 5 citing it directly.

This deviceK010811 Perc-D SpinewandArthrocare Corp. · 2001
Descendant · cites it directly · 33 of its ownK020621 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
Descendant · 2 generations on · 32 of its ownK030954 Arthrocare Percd SpinewandArthrocare Corp. · 2003
Descendant · cites it directly · 28 of its ownK032473 Dekompressor Percutaneous Discectomy ProbeStryker Instruments · 2003 · Recalled
Descendant · 3 generations on · 24 of its ownK040338 Arthrocare Controller, Cable, Foot Control, Power Cord, Wands…Arthrocare Corp. · 2004
Descendant · 4 generations on · 21 of its ownK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007

Showing 5 of 72 descendants. See all descendants

Descendants cleared per year

2002high 8 (2012) · low 0 (2020)2026

Most influential descendants

Showing 5 of 72 · See all

K020621Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp. · 2002 · cites it directly33descendants
K030954Arthrocare Percd SpinewandArthrocare Corp. · 2003 · 2 generations on32descendants
K032473Dekompressor Percutaneous Discectomy ProbeStryker Instruments · 2003 · cites it directly28descendants
K040338Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models H0970-02…Arthrocare Corp. · 2004 · 3 generations on24descendants
K071963Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007 · 4 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010811	Perc-D Spinewand	Arthrocare Corp.	2001	—
+1	K020621	Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands	Arthrocare Corp.	2002	—
+2	K030954	Arthrocare Percd Spinewand	Arthrocare Corp.	2003	—
+1	K032473	Dekompressor Percutaneous Discectomy Probe	Stryker Instruments	2003	3
+3	K040338	Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models…	Arthrocare Corp.	2004	—
+4	K071963	Modification to: Arthrocare Arthrowands	Arthrocare Corp.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0
2004	2	0
2005	1	0
2006	2	0
2007	3	0
2008	4	0
2009	7	0
2010	2	0
2011	2	0
2012	8	0
2013	3	0
2014	2	0
2015	4	0
2016	5	0
2017	3	0
2018	5	0
2019	2	0
2021	1	0
2023	1	0
2024	3	0
2025	4	0
2026	5	0

FIG. 1 — Lineage of K010811, 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? (72)

See all 72

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

Number	Device	Applicant	Decided	Descendants
K020621	Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands	Arthrocare Corp.	2002	33
K032473	Dekompressor Percutaneous Discectomy Probe	Stryker Instruments	2003	28
K081051	Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope	Spine View, Inc.	2008	16
K100353	Spinewand Surgical Device	Arthrocare Corp.	2010	3
K132797	L'DISQ	U&I Corporation	2014	1

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, K020621 (Arthrocare Corp., 2002) has gone furthest, with 33 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/K010811 · printed Nov 5, 2026

Cite this page

510(k) Report. “K010811: Perc-D Spinewand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010811

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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