# K012605: Reprocessed Athroscopics Burs

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: Nov 7, 2001 after 86 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K833587 (1983). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963332: Thermo-Plastic Shaver Blades, Stryker Endoscopy (1996) Summary page 1.
- K973195: Total Performance System Shaver, Stryker Endoscopy (1997) Summary page 1.
- K982375: Stryker Hip Arthoroscopy Set, Stryker Endoscopy (1998) Summary page 1.

## Recalls of this device
- Jul 27, 2018 · Class II · Z-0973-2019: Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or displa
- Jan 26, 2009 · Not classified · Z-0956-2012: 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-0958-2012: 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-0961-2012: 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-0955-2012: 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-0954-2012: 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-0957-2012: 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-0959-2012: 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-0960-2012: 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/K012605
Methodology: https://510kreport.com/methodology