510(k) · Cleared
Recalled · 2009Reprocessed Stryker Arthroscopic Shavers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Medical Corp. · HRX Arthroscope
Cleared on Nov 7, 2001 as substantially equivalent to K963332 (Stryker Endoscopy, 1996) and 2 other predicates after an 86-day review. Its family tree reaches back 4 generations to 1983. It has been recalled 8 times.
- Decided
- Nov 7, 2001
- Review
- 86 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 8
- Predicates
- 3
Its longest line of descent runs back 4 generations to K833587 (1983). 20 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 4 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 3 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 2 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 1 generation backK982375 Stryker Hip Arthoroscopy SetStryker Endoscopy · 1998
- This deviceK012635 Reprocessed Stryker Arthroscopic ShaversAlliance Medical Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −3 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −2 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −1 | K982375 | Stryker Hip Arthoroscopy Set | Stryker Endoscopy | 1998 | — |
| 0 (this device) | K012635 | Reprocessed Stryker Arthroscopic Shavers | Alliance Medical Corp. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 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? (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 |
|---|---|---|---|
| * | K963332 | Thermo-Plastic Shaver BladesSummary page 2…device(s): Device description: Intended use: Indications statement: Technological characteristics: Performance data: Conclusion: = ALLIANCE MEDICAL CORPORATION K963332 Stryker® Thermo-Plastic Shaver Blades K973195 Stryker® Total Performance System Shaver Handpiece K982375 Stryker®, Stryker Hip Ar… | 1996 |
| * | K973195 | Total Performance System ShaverSummary page 2…Indications statement: Technological characteristics: Performance data: Conclusion: = ALLIANCE MEDICAL CORPORATION K963332 Stryker® Thermo-Plastic Shaver Blades K973195 Stryker® Total Performance System Shaver Handpiece K982375 Stryker®, Stryker Hip Arthroscopy Set Arthroscopic shavers can be use… | 1997 |
| * | K982375 | Stryker Hip Arthoroscopy SetSummary page 2…erformance data: Conclusion: = ALLIANCE MEDICAL CORPORATION K963332 Stryker® Thermo-Plastic Shaver Blades K973195 Stryker® Total Performance System Shaver Handpiece K982375 Stryker®, Stryker Hip Arthroscopy Set Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose f… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 26, 2009 | Not classified | Z-0956-2012 | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential… |
| Jan 26, 2009 | Not classified | Z-0958-2012 | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential… |
| Jan 26, 2009 | Not classified | Z-0961-2012 | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential… |
| Jan 26, 2009 | Not classified | Z-0955-2012 | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential… |
| Jan 26, 2009 | Not classified | Z-0954-2012 | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential… |
| Jan 26, 2009 | Not classified | Z-0957-2012 | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential… |
| Jan 26, 2009 | Not classified | Z-0959-2012 | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential… |
| Jan 26, 2009 | Not classified | Z-0960-2012 | Packaging process control | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- None of the 20 ancestors has a recall.
- 2 other devices also cite its predicate K963332.
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 Arthroscopic Shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic 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/K012635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012635: Reprocessed Stryker Arthroscopic Shavers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012635
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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