510(k) Report

510(k) · Cleared

Recalled · 2009

Reprocessed Dyonics Arthroscopic Shavers

K012611510(k) TraditionalCleared Nov 7, 200186-day reviewClass II21 CFR 888.1100Recalls 7

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alliance Medical, Inc. · HRX Arthroscope

Cleared on Nov 7, 2001 as substantially equivalent to K833587 (Dyonics, Inc., 1983) and 8 other predicates after an 86-day review. Its family tree reaches back 3 generations to 1983. It has been recalled 7 times.

Decided
Nov 7, 2001
Review
86 days
Class
Class II
Product code
HRX
Recalls
7
Predicates
9

Its longest line of descent runs back 3 generations to K833587 (1983). 14 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 3 other ancestors1994: 1 other ancestor1990: 1 other ancestor1982: 1 other ancestor1978: 1 other ancestor1996: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1988: 1 other ancestorK833587 · Disposable Arthroscopy Blade · Dyonics, Inc. · 1983K900070 · Modified Uses of the Arthroscopic Surgical System · Dyonics, Inc. · 1990K971253 · Various Arthroscopes, Endoscopic Blades, Manual Instruments · Smith & Nephew, Inc. · 1997197519801985199019952000
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 5 other ancestors K971253 · Various Arthroscopes, Endoscopic Blades, Manual Instruments · Smith & Nephew, Inc. · 1997K900070 · Modified Uses of the Arthroscopic Surgical System · Dyonics, Inc. · 1990K833587 · Disposable Arthroscopy Blade · Dyonics, Inc. · 19830
  1. Root · 3 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
  2. 2 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
  3. 1 generation backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
  4. This deviceK012611 Reprocessed Dyonics Arthroscopic ShaversAlliance Medical, Inc. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K833587Disposable Arthroscopy BladeDyonics, Inc.1983—
−2K900070Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc.1990—
−1K971253Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc.1997—
0 (this device)K012611Reprocessed Dyonics Arthroscopic ShaversAlliance Medical, Inc.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198210
198810
199010
199110
199210
199410
199530
199610
FIG. 1 — Lineage of K012611, 1983–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K833587Disposable Arthroscopy Blade
Summary page 2
…Dyonics® Turbo Whisker 7205316 Dyonics® Razorcut 7205317 Dyonics® Razorcut 7205318 Dyonics® Razorcut 7205319 Dyonics® Incisor 7205345 Dyonics® Incisor 7205459 Predicate K833587 Smith & Nephew Dyonics® Disposable device(s): Arthorscopy Blade K904284 Smith & Nephew Dyonics® Arthroscopic Surgical Blade K934…
Dyonics, Inc.1983—
*K904284Arthroscopic Surgical Blade
Summary page 2
…ut 7205318 Dyonics® Razorcut 7205319 Dyonics® Incisor 7205345 Dyonics® Incisor 7205459 Predicate K833587 Smith & Nephew Dyonics® Disposable device(s): Arthorscopy Blade K904284 Smith & Nephew Dyonics® Arthroscopic Surgical Blade K934229 Smith & Nephew Dyonics® Disposable ~ Arthroscopic Surgery Blades K953…
Smith & Nephew Dyonics, Inc.1990—
*K934299Dyonics Disposable Arthroscopic Surgery Blades Modification
Our OCR of the scanned summary read K934229, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Smith & Nephew Dyonics Disposable Arthroscopic Surgery Blades”.
Smith & Nephew Dyonics, Inc.1994—
*K953096Essential Shaver System
Summary page 2
…posable device(s): Arthorscopy Blade K904284 Smith & Nephew Dyonics® Arthroscopic Surgical Blade K934229 Smith & Nephew Dyonics® Disposable ~ Arthroscopic Surgery Blades K953096 Smith & Nephew Dyonics® EP-1 Shaver K953695 Smith & Nephew Dyonics® Disposable Arthroscopic Blades K771218 Smith & Nephew Dyoni…
Smith & Nephew Richards, Inc.1995—
*K953695Dyonics Disposable Arthroscopic Blades
Summary page 2
…Smith & Nephew Dyonics® Arthroscopic Surgical Blade K934229 Smith & Nephew Dyonics® Disposable ~ Arthroscopic Surgery Blades K953096 Smith & Nephew Dyonics® EP-1 Shaver K953695 Smith & Nephew Dyonics® Disposable Arthroscopic Blades K771218 Smith & Nephew Dyonics® Intra-Articular Shaver K820367 Smith & N…
Smith & Nephew Dyonics, Inc.1995—
*K771218Intra-Articular Shaver
Summary page 2
…h & Nephew Dyonics® Disposable ~ Arthroscopic Surgery Blades K953096 Smith & Nephew Dyonics® EP-1 Shaver K953695 Smith & Nephew Dyonics® Disposable Arthroscopic Blades K771218 Smith & Nephew Dyonics® Intra-Articular Shaver K820367 Smith & Nephew Dyonics® Intra-Articular Surgical System K971253 Smith & Ne…
Dyonics, Inc.1978—
*K820367Intra-Articular Surgical System
Summary page 2
…lades K953096 Smith & Nephew Dyonics® EP-1 Shaver K953695 Smith & Nephew Dyonics® Disposable Arthroscopic Blades K771218 Smith & Nephew Dyonics® Intra-Articular Shaver K820367 Smith & Nephew Dyonics® Intra-Articular Surgical System K971253 Smith & Nephew Dyonics® Endoscopic Surgery Blades K900070 Smith &…
Dyonics, Inc.1982—
*K971253Various Arthroscopes, Endoscopic Blades, Manual Instruments
Summary page 2
…& Nephew Dyonics® Disposable Arthroscopic Blades K771218 Smith & Nephew Dyonics® Intra-Articular Shaver K820367 Smith & Nephew Dyonics® Intra-Articular Surgical System K971253 Smith & Nephew Dyonics® Endoscopic Surgery Blades K900070 Smith & Nephew Dyonics® Modified Uses of the Arthroscopic Surgical Syst…
Smith & Nephew, Inc.1997—
*K900070Modified Uses of the Arthroscopic Surgical System
Summary page 2
…Smith & Nephew Dyonics® Intra-Articular Shaver K820367 Smith & Nephew Dyonics® Intra-Articular Surgical System K971253 Smith & Nephew Dyonics® Endoscopic Surgery Blades K900070 Smith & Nephew Dyonics® Modified Uses of the Arthroscopic Surgical System, Trimmer Blade and Full Radius Blade Device Arthroscopi…
Dyonics, Inc.1990—

Also cleared against K833587: 4 other devices →

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

DateClassRecallRoot causeReason
Jan 26, 2009Not classifiedZ-0947-2012Packaging process controlOn 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, 2009Not classifiedZ-0948-2012Packaging process controlOn 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, 2009Not classifiedZ-0949-2012Packaging process controlOn 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, 2009Not classifiedZ-0950-2012Packaging process controlOn 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, 2009Not classifiedZ-0951-2012Packaging process controlOn 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, 2009Not classifiedZ-0952-2012Packaging process controlOn 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, 2009Not classifiedZ-0953-2012Packaging process controlOn 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 7 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 3 companies; a new generation was cleared every 6.3 years on median.
  • None of the 14 ancestors has a recall.
  • 4 other devices also cite its predicate K833587.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

What is it indicated for?

The 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.

Also cleared against K833587

4 other devices cite the same predicate.

  • K012624Reprocessed Arthroscopic Blades, Arthroscopic Shavers, Shaver Blade, Blade, Limited Reuse Blade…Medical Instruments Technology, Inc. · 2001
  • K012652Reprocessed Dyonics Arthroscopic BursAlliance Medical Corp. · 20017 recalls
  • K971253Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
  • K900070Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990

More from Alliance Medical, Inc.

11 FDA decisions under this applicant name. See the company

  • K051438Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc. · 20061 recall
  • K050518Reprocessed Phacoemuisification TipsAlliance Medical, Inc. · 2005
  • K030187Reprocessed Electrophysiology CatheterAlliance Medical, Inc. · 200328 recalls
  • K021654Reprocessed Compression SleeveAlliance Medical, Inc. · 2003
  • K012634Reprocessed External Fixation DeviceAlliance Medical, Inc. · 2002

Recent decisions in HRX

The HRX category page

  • K263208Vantage Lumbar Decompression KitSurGenTec, LLC · 2026
  • K260156TruVision Single-Use 1.9mm Arthroscopy SystemNexus CMF, LLC · 2026
  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
  • K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG · 2026
  • K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC · 2026

https://510kreport.com/device/K012611 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012611: Reprocessed Dyonics 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/K012611

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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