510(k) · Cleared

Recalled · Class II · 2015

X-Treme Arthroscopic Pump and Shaver System

K041824510(k) TraditionalCleared Jan 7, 2005185-day reviewClass II21 CFR 888.1100Recalls 2

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

Future Medical Systems, SA · HRX Arthroscope

Cleared on Jan 7, 2005 as substantially equivalent to K954465 (Future Medical Systems, Inc., 1995) and 3 other predicates after a 185-day review. Its family tree reaches back 1 generation to 1991. 6 later devices descend from it. It has been recalled 2 times.

Decided: Jan 7, 2005
Review: 185 days
Class: Class II
Product code: HRX
Recalls: 2
Predicates: 4

Its longest line of descent runs back 1 generation to K913028 (1991). 4 ancestors in all. 6 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK913028 Arthro-Flow Irrigation 2 SystemDavol, Inc. · 1991
This deviceK041824 X-Treme Arthroscopic Pump and Shaver SystemFuture Medical Systems, SA · 2005
Descendant · cites it directly · 2 of its ownK050580 Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc. · 2005
Descendant · 2 generations on · 1 of its ownK051326 Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2005 · Recalled
Descendant · 3 generations on · 0 of its ownK171794 Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2017
Descendant · cites it directly · 0 of its ownK131191 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM…Depuy Mitek, A Johnson & Johnson Company · 2013
Descendant · cites it directly · 0 of its ownK130912 Omnicut Resection BladeDepuy Mitek, A Johnson & Johnson Company · 2013

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005high 2 (2005) · low 0 (2007)2026

Most influential descendants

Showing 5 of 6 · See all

K050580Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc. · 2005 · cites it directly2descendants
K051326Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2005 · 2 generations on1descendant
K171794Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2017 · 3 generations on0descendants
K1311914MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado Bur Plus…Depuy Mitek, A Johnson & Johnson Company · 2013 · cites it directly0descendants
K130912Omnicut Resection BladeDepuy Mitek, A Johnson & Johnson Company · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913028	Arthro-Flow Irrigation 2 System	Davol, Inc.	1991	—
0 (this device)	K041824	X-Treme Arthroscopic Pump and Shaver System	Future Medical Systems, SA	2005	—
+1	K050580	Smith & Nephew Intelijet Fluid Management Systems	Smith & Nephew Endoscopy, Inc.	2005	—
+2	K051326	Smith & Nephew 25 Fluid Management System	Smith & Nephew, Inc.	2005	6
+3	K171794	Smith & Nephew 25 Fluid Management System	Smith & Nephew, Inc.	2017	—
+1	K131191	4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado…	Depuy Mitek, A Johnson & Johnson Company	2013	—
+1	K130912	Omnicut Resection Blade	Depuy Mitek, A Johnson & Johnson Company	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	1	0
2013	2	0
2017	1	0

FIG. 1 — Lineage of K041824, 1991–2017Source: 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 HRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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What was it cleared against? (4)

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
*	K954465	FMS Duo Summary page 1 …traTM arthroscopic pump and shaver system. III. Classification: Class II. Product code is HRX. This device is described in 21 C.F.R § 888.1100 IV. Predicate devices: K954465: FMS DUO (pump and shaver), Future Medical Systems K913028: Arthro-Flow Irrigation system (pump), Davol (BARD) K932699: ARTHREX A…	Future Medical Systems, Inc.	1995	2
*	K913028	Arthro-Flow Irrigation 2 System Summary page 1 …tion: Class II. Product code is HRX. This device is described in 21 C.F.R § 888.1100 IV. Predicate devices: K954465: FMS DUO (pump and shaver), Future Medical Systems K913028: Arthro-Flow Irrigation system (pump), Davol (BARD) K932699: ARTHREX AR-8200 SHAVER SYSTEM (Arthrex) K940075: SHAVER BLADE SET (A…	Davol, Inc.	1991	—
*	K932699	Arthrex AR-8200 Shaver System Summary page 1 …ed in 21 C.F.R § 888.1100 IV. Predicate devices: K954465: FMS DUO (pump and shaver), Future Medical Systems K913028: Arthro-Flow Irrigation system (pump), Davol (BARD) K932699: ARTHREX AR-8200 SHAVER SYSTEM (Arthrex) K940075: SHAVER BLADE SET (Arthrex) V. Intended use: The NeXtraTM arthroscopic pump an…	Arthrex, Inc.	1994	—
*	K940075	Shaver Blade Set Summary page 1 …K954465: FMS DUO (pump and shaver), Future Medical Systems K913028: Arthro-Flow Irrigation system (pump), Davol (BARD) K932699: ARTHREX AR-8200 SHAVER SYSTEM (Arthrex) K940075: SHAVER BLADE SET (Arthrex) V. Intended use: The NeXtraTM arthroscopic pump and shaver system is intended to provide controlled…	Arthrex, Inc.	1994	—

Also cleared against K954465: 11 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K050580	Smith & Nephew Intelijet Fluid Management Systems	Smith & Nephew Endoscopy, Inc.	2005	2
K131191	4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado Bur Plus…	Depuy Mitek, A Johnson & Johnson Company	2013	0
K130912	Omnicut Resection Blade	Depuy Mitek, A Johnson & Johnson Company	2013	0
K060172	Rema Shaver Blades	Rema Medizintechnik GmbH.	2006	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 20, 2015	Class II	Z-0656-2016	Process control	Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Nov 20, 2015	Class II	Z-0657-2016	Process control	Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 4 ancestors has a recall of any class.
Of its descendants, K050580 (Smith & Nephew Endoscopy, Inc., 2005) has gone furthest, with 2 descendants of its own.
11 other devices also cite its predicate K954465.

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	—

What is it indicated for?

The NeXtraTM arthroscopic pump and shaver system is intended to provide controlled fluid distension and suction, controlled cutting, burring, shaving and abrading of bone and tissue during orthopedic procedures of the knee, shoulder, elbow, wrist, ankle, hip, small joints and temporal mandibular joint (TMJ).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041824 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041824: X-Treme Arthroscopic Pump and Shaver System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041824

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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