# K941333: SE5 Arthroscopy Sytem

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Nov 10, 1994 after 237 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.
256 later devices descend from it; 2 cite it directly.
0 of 257 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K974771: Stryker SE5 Arthroscopy System with Hermes Voice Control (1998), 254 descendants of its own
- K991696: Stryker Hermes-Ready Total Performance System (1999), 253 descendants of its own
- K032117: Stryker Total Performance (TPS) System (2003), 238 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own

## Recalls of this device
- May 19, 2014 · Class II · Z-1872-2014: STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.

Source page: https://510kreport.com/device/K941333
Methodology: https://510kreport.com/methodology