# K041824: X-Treme Arthroscopic Pump and Shaver System

- Pathway: 510(k) (Traditional)
- Applicant: Future Medical Systems, SA
- Decided: Jan 7, 2005 after 185 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913028 (1991). 4 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954465: FMS Duo, Future Medical Systems, Inc. (1995) Summary page 1.
- K913028: Arthro-Flow Irrigation 2 System, Davol, Inc. (1991) Summary page 1.
- K932699: Arthrex AR-8200 Shaver System, Arthrex, Inc. (1994) Summary page 1.
- K940075: Shaver Blade Set, Arthrex, Inc. (1994) Summary page 1.

## Most influential descendants
- K050580: Smith & Nephew Intelijet Fluid Management Systems (2005), 2 descendants of its own
- K051326: Smith & Nephew 25 Fluid Management System (2005), 1 descendant of its own
- K171794: Smith & Nephew 25 Fluid Management System (2017), 0 descendants of its own
- K131191: 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado Bur Plus, 4MM & 5MM Aggressive Blade Plus (2013), 0 descendants of its own
- K130912: Omnicut Resection Blade (2013), 0 descendants of its own

## Recalls of this device
- Nov 20, 2015 · Class II · Z-0656-2016: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
- Nov 20, 2015 · Class II · Z-0657-2016: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.

## Indications for use
The NeXtraTM arthroscopic pump and shaver system is intended to provide controlled fluid distension and suction, controlled cutting, burring, shaving and abrading of bone and tissue during orthopedic procedures of the knee, shoulder, elbow, wrist, ankle, hip, small joints and temporal mandibular joint (TMJ).

Source page: https://510kreport.com/device/K041824
Methodology: https://510kreport.com/methodology