510(k) · Cleared
ClearedReprocessed Used Disposable Arthroscopic Blades and Burs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Device Services · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Cleared on Sep 18, 2002 as substantially equivalent to K953695 (Smith & Nephew Dyonics, Inc., 1995) after a 30-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 18, 2002
- Review
- 30 days
- Class
- Class I
- Product code
- HWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953695 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
- This deviceK022744 Reprocessed Used Disposable Arthroscopic Blades and BursMedical Device Services · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953695 | Dyonics Disposable Arthroscopic Blades | Smith & Nephew Dyonics, Inc. | 1995 | — |
| 0 (this device) | K022744 | Reprocessed Used Disposable Arthroscopic Blades and Burs | Medical Device Services | 2002 | — |
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 HWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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…and Dyodcs Disposable Arthroscopic BladedBurs are substantially equivalent to disposable arthroscopic blades/burs marketed by Smith & Nephew Dyonics under 510(k) Number K953695. MDS claims that Reprocessed Stryker and Dyonics Disposable Arthroscopic BIades/Burs are able to withstand the necessary cleanin… | 1995 |
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?
- Its one ancestor has no recall.
- 10 other devices also cite its predicate K953695.
How does its category compare?
All HWE devicesHWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HWE
Too few HWE 510(k)s in any year since 2007 to give a median.
Recalls per year · HWE
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWE
2,848in 2025
MAUDE reports naming product code HWE, 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 | 1 | — | 0 | 123 |
| 2008 | 0 | — | 0 | 72 |
| 2009 | 0 | — | 4 | 180 |
| 2010 | 0 | — | 2 | 297 |
| 2011 | 1 | — | 2 | 138 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 1,243 |
| 2014 | 0 | — | 3 | 3,794 |
| 2015 | 1 | — | 5 | 5,567 |
| 2016 | 0 | — | 2 | 4,974 |
| 2017 | 0 | — | 1 | 5,074 |
| 2018 | 0 | — | 0 | 3,589 |
| 2019 | 0 | — | 0 | 3,452 |
| 2020 | 0 | — | 0 | 3,248 |
| 2021 | 0 | — | 0 | 3,140 |
| 2022 | 0 | — | 0 | 3,327 |
| 2023 | 0 | — | 0 | 3,397 |
| 2024 | 0 | — | 0 | 3,686 |
| 2025 | 0 | — | 0 | 2,848 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Artlrosc~picblades and burs aTe single use instruments consisting of several tubes and designs. The inner blade rotation is driven by a motor.
Arthroscopy blades and burs are indicated for resection of tissue withiti joint spaces under arthroscopic control.
Medical Device Services intends to reprocess arthroscopy blades and burs. Reprocessing includes all the steps performed to make a contaminated single use device patient ready.
Only disposable, nan angled arthroscopy blades and burs manufkctured by Dyonics and Stryker, that are currently sold an the market (which have tnet premarket requirements by the original manufacturer for single use) will be reprocessed by Medical Device Services.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022744 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022744: Reprocessed Used Disposable Arthroscopic Blades and Burs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022744
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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