# K012613: Reprocssed Linvatec Shavers

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical, Inc.
- Decided: Nov 7, 2001 after 86 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K862807 (1986). 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)
- K940515: Poly Blades, Linvatec Corp. (1994) Summary page 1.
- K971059: Universal Drive System, Linvatec Corp. (1997) Summary page 1.
- K981269: Universal Drive System, Linvatec Corp. (1998) Summary page 1.
- K981636: Integrated Drive/Pump System, Linvatec Corp. (1998) Summary page 1.
- K990524: E9000 System, Linvatec Corp. (1999) Summary page 1.

## Recalls of this device
- Jan 26, 2009 · Not classified · Z-0962-2012: 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 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.

Source page: https://510kreport.com/device/K012613
Methodology: https://510kreport.com/methodology