# K012652: Reprocessed Dyonics Arthroscopic Burs

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: Nov 8, 2001 after 87 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K833587 (1983). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833587: Disposable Arthroscopy Blade, Dyonics, Inc. (1983) Summary page 1.
- K904284: Arthroscopic Surgical Blade, Smith & Nephew Dyonics, Inc. (1990) Summary page 1.
- K934299: Dyonics Disposable Arthroscopic Surgery Blades Modification, Smith & Nephew Dyonics, Inc. (1994). 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”.
- K953096: Essential Shaver System, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K953695: Dyonics Disposable Arthroscopic Blades, Smith & Nephew Dyonics, Inc. (1995) Summary page 1.
- K771218: Intra-Articular Shaver, Dyonics, Inc. (1978) Summary page 1.
- K820367: Intra-Articular Surgical System, Dyonics, Inc. (1982) Summary page 2.
- K971253: Various Arthroscopes, Endoscopic Blades, Manual Instruments, Smith & Nephew, Inc. (1997) Summary page 2.
- K900070: Modified Uses of the Arthroscopic Surgical System, Dyonics, Inc. (1990) Summary page 2.

## Recalls of this device
- Jan 26, 2009 · Not classified · Z-0947-2012: 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 ma
- Jan 26, 2009 · Not classified · Z-0948-2012: 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 ma
- Jan 26, 2009 · Not classified · Z-0949-2012: 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 ma
- Jan 26, 2009 · Not classified · Z-0950-2012: 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 ma
- Jan 26, 2009 · Not classified · Z-0951-2012: 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 ma
- Jan 26, 2009 · Not classified · Z-0952-2012: 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 ma
- Jan 26, 2009 · Not classified · Z-0953-2012: 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 ma

## Indications for use
Reprocessed Arthroscopic Burs 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.

Source page: https://510kreport.com/device/K012652
Methodology: https://510kreport.com/methodology