510(k) · Cleared
ClearedMedline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Service and Savings, Inc. · NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Cleared on Jun 23, 2017 as substantially equivalent to K083306 (Arthrocare Corp., 2008) after a 49-day review. Its family tree reaches back 13 generations to 2001.
- Decided
- Jun 23, 2017
- Review
- 49 days
- Class
- Class II
- Product code
- NUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K011083 (2001). 25 ancestors in all, the oldest K000778 (2000). No later device cites it as a predicate yet.
- Root · 13 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 9 generations between
- 3 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 2 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 1 generation backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- This deviceK171324 Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith &…Surgical Instrument Service and Savings, Inc. · 2017
Show all 13 generations
- Root · 13 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 12 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 11 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 10 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 9 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 8 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 7 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 6 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- 5 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 4 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 3 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 2 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 1 generation backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- This deviceK171324 Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith &…Surgical Instrument Service and Savings, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −12 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −11 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −10 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −9 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −8 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −7 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −6 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −5 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −4 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −3 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| −2 | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 12 |
| −1 | K083306 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 1 |
| 0 (this device) | K171324 | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics | Surgical Instrument Service and Savings, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
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 NUJ? 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 NUJ device
- #1 K220411 Reprocessed LigaSure Curved, Small Jaw, Open…score 8.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K083306 | Modification to Arthrocare ArthrowandsSummary page 7…Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR Classification 878.4400) Product code: NUJ Predicate K083306 Modification to ArthroCare ArthroWands Device Reference K093165 ArthroCare System 1500 Controller, ArthroWands… | 2008 |
| † | K093165 | Arthrocare System 15000 Controller, Arthrowands | 2009 |
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 16 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 4 of the 25 ancestors have a recall of any class.
- 7 other devices also cite its predicate K083306.
How does its category compare?
All NUJ devicesNUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NUJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NUJ
88in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUJ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NUJ
38in 2025
MAUDE reports naming product code NUJ, 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 | 0 | — | 0 | 4 |
| 2008 | 1 | — | 2 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 39 |
| 2013 | 2 | — | 0 | 161 |
| 2014 | 1 | — | 0 | 74 |
| 2015 | 2 | — | 0 | 25 |
| 2016 | 5 | 155 | 0 | 52 |
| 2017 | 3 | 49 | 0 | 51 |
| 2018 | 7 | 88 | 0 | 14 |
| 2019 | 1 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 59 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 2 | — | 0 | 31 |
| 2023 | 1 | — | 3 | 27 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 0 | — | 11 | 38 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medline ReNewal Reprocessed ArthroCare ArthroWands models ASHA 4250-01; ASH 4250-01; ASHA 2530-01; ASHA 3730-01; ASHA 4830-01; and ASH 4830-01 and Medline ReNewal Reprocessed Smith & Nephew Dyonics model 72202140 ablation wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Ablation and Debridement: ACL/PCL (knee); acromioplasty (shoulder); articular…
Read the full statement (196 words)
The Medline ReNewal Reprocessed ArthroCare ArthroWands models ASHA 4250-01; ASH 4250-01; ASHA 2530-01; ASHA 3730-01; ASHA 4830-01; and ASH 4830-01 and Medline ReNewal Reprocessed Smith & Nephew Dyonics model 72202140 ablation wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Ablation and Debridement: ACL/PCL (knee); acromioplasty (shoulder); articular cartilage (all joints); bursectomy (all joints); chondroplasty (all joints); fascia (all joints); ligament (all joints); notchplasty (knee); scar tissue (all joints); soft tissue (all joints);subacromial decompression (shoulder); synovectomy (all joints); and tendon (all joints).
Excision and Resection: acetabular labrum (hip); articular labrum (all joints); capsule (all joints); capsular release (knee); cartilage flaps (knee); cysts (all joints); discoid meniscus (knee); frozen shoulder release (shoulder); glenoidale labrum (shoulder); lateral release (knee); ligament (all joints); loose bodies (all joints); meniscal cystectomy (knee); meniscectomy (knee); plica removal (all joints); scar tissue (all joints); soft tissue (all joints); synovial membrane (all joints); tendon (all joints); triangular fibrocartilage (TFCC), (wrist); and villusectomy (knee).
Coagulation: ACL/PCL (knee); articular cartilage (all joints); carpal ligaments (wrist); glenohumeral capsule (shoulder); ligament (all joints); medial retinaculum (knee); rotator cuff (shoulder); tendon (all joints) and wrist tendons (wrist).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171324: Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171324
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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