510(k) · Cleared
ClearedArticulator Arthroscopic Bur
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joint Preservation Innovations, LLC · HRX Arthroscope
Cleared on Nov 21, 2025 as substantially equivalent to K071859 (Stryker Endoscopy, 2007) and 1 other predicate after an 88-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Nov 21, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K011083 (2001). 40 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 8 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 7 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 6 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 5 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 4 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 3 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 2 generations backK041810 Serfas Energy SystemStryker Endoscopy · 2004 · Recalled
- 1 generation backK071859 Stryker Crossfire SystemStryker Endoscopy · 2007 · Recalled
- This deviceK252666 Articulator Arthroscopic BurJoint Preservation Innovations, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −7 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −6 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −5 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −4 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −3 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −2 | K041810 | Serfas Energy System | Stryker Endoscopy | 2004 | 3 |
| −1 | K071859 | Stryker Crossfire System | Stryker Endoscopy | 2007 | 2 |
| 0 (this device) | K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2020 | 2 | 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 |
|---|---|---|---|
| * | K071859 | Stryker Crossfire SystemSummary page 5…imary Predicate Manufacturer: Stryker Endoscopy Primary Predicate Trade Name: Stryker Crossfire System Primary Predicate 510(k): K071859 Secondary Predicate Manufacturer: LivsMed Inc. Secondary Predicate Trade Name: ArtiSential Laparoscopic Inst… | 2007 |
| * | K200875 | ArtiSential Laparoscopic Instruments - ElectrodesSummary page 5…nufacturer: LivsMed Inc. Secondary Predicate Trade Name: ArtiSential Laparoscopic Instruments - Electrodes Secondary Predicate 510(k): K200875 No reference devices were used in this submission. IV. DEVICE DESCRIPTION The Articulator Arthroscopic Bur can be used to ab… | 2020 |
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 24 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 9 of the 40 ancestors have a recall of any class.
- 1 other device also cites its predicate K071859.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 ArticulatorTM Arthroscopic Bur is indicated for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip, to provide abrasion, resection, debridement, and removal of bone and cartilage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252666: Articulator Arthroscopic Bur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252666
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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