# K061134: Eberle Shaver System C2 and Shaver Blades

- Pathway: 510(k) (Traditional)
- Applicant: Efs Eberle Feinwerktechnische Systeme
- Decided: Sep 1, 2006 after 130 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973195: Total Performance System Shaver, Stryker Endoscopy (1997) Summary page 2.
- K030009: Ksea Powershaver System S2, Karl Storz Endoscopy (2003) Summary page 2.
- K990524: E9000 System, Linvatec Corp. (1999) Summary page 2.
- K002523: Advantage Drive System, Linvatec Corp. (2000) Summary page 2.

## Most influential descendants
- K092977: Eberle Shaver System Accessories (2010), 1 descendant of its own
- K193608: EBERLE Shaver System C3 and Accessories (2021), 0 descendants of its own

## Indications for use
The EBERLE Shaver System C2 is a powered instrument system and consists of a control unit, a footswitch, a handpiece and accessories. It is designed for arthroscopy surgical procedures like shaving, burring, abrading, cutting and resecting of fibrous tissue, cartilage tissue and bone conducted by qualified surgeons only.

Source page: https://510kreport.com/device/K061134
Methodology: https://510kreport.com/methodology