# K030009: Ksea Powershaver System S2

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: Apr 2, 2003 after 90 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K061134: Eberle Shaver System C2 and Shaver Blades (2006), 2 descendants of its own
- K092977: Eberle Shaver System Accessories (2010), 1 descendant of its own
- K193608: EBERLE Shaver System C3 and Accessories (2021), 0 descendants of its own
- K060172: Rema Shaver Blades (2006), 0 descendants of its own

## Recalls of this device
- Oct 11, 2024 · Class II · Z-0526-2025: Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.

## Indications for use
The Karl Storz Powershaver System S2 is intended to provide controlled cutting, shaving and abrading of bone and tissue during arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, wrist, hip, and temporal mandibular joint (TMJ) conducted by qualified surgeons.

Source page: https://510kreport.com/device/K030009
Methodology: https://510kreport.com/methodology