510(k) · Cleared
Cleared4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado Bur Plus, 4MM & 5MM Aggressive Blade Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · HRX Arthroscope
Cleared on Jul 22, 2013 as substantially equivalent to K954465 (Future Medical Systems, Inc., 1995) and 1 other predicate after an 87-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Jul 22, 2013
- Review
- 87 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K913028 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK913028 Arthro-Flow Irrigation 2 SystemDavol, Inc. · 1991
- 1 generation backK041824 X-Treme Arthroscopic Pump and Shaver SystemFuture Medical Systems, SA · 2005 · Recalled
- This deviceK131191 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM…Depuy Mitek, A Johnson & Johnson Company · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913028 | Arthro-Flow Irrigation 2 System | Davol, Inc. | 1991 | — |
| −1 | K041824 | X-Treme Arthroscopic Pump and Shaver System | Future Medical Systems, SA | 2005 | 2 |
| 0 (this device) | K131191 | 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado… | 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 |
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 |
|---|---|---|---|
| * | K954465 | FMS DuoSummary page 1…substantially equivalent to the Blades and Burrs covered in the following cleared systems: * K954465 - FMVS DUO Pump and shaver system * K04 1824 - NeXtraT arthroscopic pump and shaver system Device… | 1995 |
| * | K041824 | X-Treme Arthroscopic Pump and Shaver SystemSummary page 1…red in the following cleared systems: * K954465 - FMVS DUO Pump and shaver system * K04 1824 - NeXtraT arthroscopic pump and shaver system Device Classification Classification Name: Arthroscope… | 2005 |
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 22 years and passes through 3 companies; a new generation was cleared every 13.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 11 other devices also cite its predicate K954465.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 EMS Blades and Burrs are an accessory to the FMS Fluid Management Systems. FMVS Blades and Burrs are intended to provide controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131191: 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado Bur Plus, 4MM & 5MM Aggressive Blade Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131191
Report an extraction error
Are you the manufacturer?
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