# K053640: Integra

- Pathway: 510(k) (Traditional)
- Applicant: Direx Systems Corp.
- Decided: Mar 1, 2006 after 61 days
- Product code: LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to P840008 (1984). 15 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P920051: Storz Modulith (TM) Lithotripter, KARL STORZ Endoscopy-America, Inc. (1995) Summary page 1.
- K010340: Modulith Lithotripsy, Model SLK for the Fragmentation of Urinary and Upper Ureteral Calculi, Karl Storz Lithotripsy-America, Inc. (2001) Summary page 1.
- K041582: Modification to Tripter X-1 Compact Duet, Direx Systems Corp. (2004) Summary page 1.
- K041213: 3DSCOPE, Direx Systems Corp. (2004) Summary page 1.

## Most influential descendants
- K062147: Integra SL (2006), 3 descendants of its own
- K072538: Piezolith 3000 Triple-Focus Lithotripter (2008), 2 descendants of its own
- K252913: Break Wave (2026), 1 descendant of its own
- K261086: Break Wave (2026), 0 descendants of its own
- K111947: Duet Magna (2012), 0 descendants of its own

## Indications for use
The INTEGRA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter

Source page: https://510kreport.com/device/K053640
Methodology: https://510kreport.com/methodology