510(k) · Cleared
ClearedLimited Reuse Arthroscopic Blades
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Dyonics, Inc. · HRX Arthroscope
Cleared on Feb 8, 1996 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 8, 1996
- Review
- 55 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK955914 Limited Reuse Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK023777 Arthronet Blackline 2 and 3 Piece Arthroscopic Blades, Models 123…Arthronet Medical, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK060172 Rema Shaver BladesRema Medizintechnik GmbH. · 2006
- Descendant · cites it directly · 0 of its ownK971676 Limited Reuse Endoscopic BladesSmith & Nephew, Inc. · 1997
Most influential descendants
Showing 3 of 3 · See all- K023777Arthronet Blackline 2 and 3 Piece Arthroscopic Blades, Models 123, 133, 153, 163, 173…Arthronet Medical, Inc. · 2002 · cites it directly1descendant
- K060172Rema Shaver BladesRema Medizintechnik GmbH. · 2006 · cites it directly0descendants
- K971676Limited Reuse Endoscopic BladesSmith & Nephew, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955914 | Limited Reuse Arthroscopic Blades | Smith & Nephew Dyonics, Inc. | 1996 | — |
| +1 | K023777 | Arthronet Blackline 2 and 3 Piece Arthroscopic Blades, Models 123, 133, 153… | Arthronet Medical, Inc. | 2002 | — |
| +1 | K060172 | Rema Shaver Blades | Rema Medizintechnik GmbH. | 2006 | — |
| +1 | K971676 | Limited Reuse Endoscopic Blades | Smith & Nephew, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K023777 (Arthronet Medical, Inc., 2002) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K955914 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955914: Limited Reuse Arthroscopic Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955914
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026