510(k) · Cleared
ClearedReprocessed Powered Arthroscopic Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · HRX Arthroscope
Cleared on Nov 2, 2001 as substantially equivalent to K971059 (Linvatec Corp., 1997) and 2 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1986. 1 later device descends from it.
- Decided
- Nov 2, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K862807 (1986). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 2 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 1 generation backK971059 Universal Drive SystemLinvatec Corp. · 1997
- This deviceK012536 Reprocessed Powered Arthroscopic AccessoriesSterilmed, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK113028 Medisiss Reprocessed Arthroscopic Shavers and BursMedisiss · 2011
Most influential descendants
Showing 1 of 1 · See all- K113028Medisiss Reprocessed Arthroscopic Shavers and BursMedisiss · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −2 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −1 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| 0 (this device) | K012536 | Reprocessed Powered Arthroscopic Accessories | Sterilmed, Inc. | 2001 | — |
| +1 | K113028 | Medisiss Reprocessed Arthroscopic Shavers and Burs | Medisiss | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K971059 | Universal Drive SystemSummary page 1…eprocessed powered arthroscopic accessories are substantially equivalent to: e The powered arthroscopic accessories included in the - Linvatec Universal Drive System (K971059); e The Smith & Nephew Dyonics Disposable Endoscopic Surgery Blades (K970511); e The Smith & Nephew Dyonics Disposable Arthrosc… | 1997 |
| * | K970511 | Dyonics Disposable Endoscopic Surgery BladesSummary page 1…e The powered arthroscopic accessories included in the - Linvatec Universal Drive System (K971059); e The Smith & Nephew Dyonics Disposable Endoscopic Surgery Blades (K970511); e The Smith & Nephew Dyonics Disposable Arthroscopic Blades (K953695); and e Their counterparts from the original manufacture… | 1997 |
| * | K953695 | Dyonics Disposable Arthroscopic BladesSummary page 1…ersal Drive System (K971059); e The Smith & Nephew Dyonics Disposable Endoscopic Surgery Blades (K970511); e The Smith & Nephew Dyonics Disposable Arthroscopic Blades (K953695); and e Their counterparts from the original manufacturers. SterilMed’s reprocessed powered arthroscopic accessories consist of… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113028 | Medisiss Reprocessed Arthroscopic Shavers and Burs | 2011 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K113028 (Medisiss, 2011) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K971059.
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 | — |
What is it indicated for?
Reprocessed powered arthroscopic accessories are intended for use in operative large and small joint arthroscopic procedures and Functional Endoscopic Sinus Surgery (FESS). These accessories are indicated for resection of soft, osseous and cartilaginous tissue, and bone in large and small articular cavities and FESS.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012536 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012536: Reprocessed Powered Arthroscopic Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012536
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026