510(k) · Cleared
ClearedOmnicut Resection Blade
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 Jun 14, 2013 as substantially equivalent to K953695 (Smith & Nephew Dyonics, Inc., 1995) and 2 other predicates after a 73-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Jun 14, 2013
- Review
- 73 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K913028 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
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) | 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 | 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? (3)
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 |
|---|---|---|---|
| * | K953695 | Dyonics Disposable Arthroscopic BladesSummary page 1…Name of Medical Device OMNICUT " Resection Blade Blade Proprietary Name: Common Name: Substantial The OMNICUT"" blades are substantially equivalent to: Equivalence e K953695: Dyonics Disposable Arthroscopic Blades (Full Radius Bonecutter Facility blade) . K954465: FMS DUO® pump and shaver system (FMS… | 1995 |
| * | K954465 | FMS DuoSummary page 1…ubstantial The OMNICUT"" blades are substantially equivalent to: Equivalence e K953695: Dyonics Disposable Arthroscopic Blades (Full Radius Bonecutter Facility blade) . K954465: FMS DUO® pump and shaver system (FMS blades) K041824: FMS NeXtra" arthroscopic pump and shaver system (FMS blades) Device Class… | 1995 |
| * | K041824 | X-Treme Arthroscopic Pump and Shaver SystemSummary page 1…alent to: Equivalence e K953695: Dyonics Disposable Arthroscopic Blades (Full Radius Bonecutter Facility blade) . K954465: FMS DUO® pump and shaver system (FMS blades) K041824: FMS NeXtra" arthroscopic pump and shaver system (FMS blades) Device Classification Name: Arthroscope Classification Classificati… | 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 6 ancestors have a recall of any class.
- 10 other devices also cite its predicate K953695.
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 FMS Blades and Burrs are an accessory to the FMS Fluid Management Systems. FMS 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130912: Omnicut Resection Blade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130912
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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