510(k) · Cleared
Recalled · 2008Athrocare Topaz Arthrowands
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · HRX Arthroscope
Cleared on Mar 6, 2006 as substantially equivalent to K011083 (Arthrocare Corp., 2001) and 1 other predicate after a 74-day review. Its family tree reaches back 7 generations to 2001. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 6, 2006
- Review
- 74 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K011083 (2001). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 6 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 5 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 4 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 3 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 2 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 1 generation backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- This deviceK053567 Athrocare Topaz ArthrowandsArthrocare Corp. · 2006
- Descendant · cites it directly · 1 of its ownK080282 Arthrocare Controllers (System 2000,1100,1200), Model H2076-00…Arthrocare Corp. · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK140521 Topaz EZ Microdebrider Coblation Wand with Integrated Finger SwitchArthroCare Corporation · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −6 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −5 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −4 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −3 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −2 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −1 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| 0 (this device) | K053567 | Athrocare Topaz Arthrowands | Arthrocare Corp. | 2006 | — |
| +1 | K080282 | Arthrocare Controllers (System 2000,1100,1200), Model H2076-00, H2079-00… | Arthrocare Corp. | 2008 | 1 |
| +2 | K140521 | Topaz EZ Microdebrider Coblation Wand with Integrated Finger Switch | ArthroCare Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 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 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand | 2001 |
| * | K052686 | Arthrocare ArthrowandsSummary page 1…agulation Device and Accessonies (21 CFR 878.4400) Predicate Devices ArthroCarc' ArthroWands® KOI 1083, K052686 Product Description The ArthroCare Topaz ArthroWands are bipolar, single use, high frequency electrosurgical devices designed fo… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080282 | Arthrocare Controllers (System 2000,1100,1200), Model H2076-00, H2079-00, H3000-00… | 2008 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 31, 2008 | Not classified | Z-1657-2008 | Packaging process control | Devices for which sterility may be compromised as evidenced by punctures in the plastic tray during shipping. The risk to the patient is a potential infection subsequent to the surgical procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 5 months on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K080282 (Arthrocare Corp., 2008) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K011083.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 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 ArthroCare Topaz ArthroWands are indicated for debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
Fasciotomny — Foot
Synovectomy — Foot
Tendonotomy — Knee, Wrist, Elbow, Ankle, Shoulder, Foot
Rotator Cuff Tendonotomy — Shoulder
Capsulotomy — Foot
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053567 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053567: Athrocare Topaz Arthrowands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053567
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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