Model note · PCNL System

EMS Swiss LithoClast Trilogy Lithotripsy System

Name: EMS Swiss LithoClast Trilogy Lithotripsy System
Brand: Swiss LithoClast Trilogy

The LithoClast Trilogy is an intracorporeal lithotripter for kidney, ureter and bladder stones that combines ultrasonic vibration and electromagnetically generated ballistic impacts in one probe and one handpiece. A console sets the energy, a two step foot pedal controls suction and energy, and a peristaltic pump or pinch valve version clears fragments into an optional stone catcher.

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The model

Maker, model and type.

Maker: EMS Electro Medical Systems SA (distributed by Boston Scientific)
Model: Swiss LithoClast Trilogy Lithotripsy System
Device type: PCNL System
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Operating modes	Ultrasound alone, ballistic alone, or combined	Source
Ultrasound	Transducer frequency 24 kHz (as listed for the predicate; same for Trilogy); maximum amplitude 60 um peak to peak; power 10 to 100% in 10% steps	Source
Ballistic	Generated electromagnetically (the predicate used compressed air); 10 to 100% in 10% steps; multiple shot mode only	Source
Probes	1.1, 1.5, 1.9, 3.4 and 3.9 mm; one probe delivers both energies; RFID tag lets the console track probe type and use; EtO sterile, reusable probes validated for 4 steam cycles after first use	Source
Console	Touchscreen; 135 x 360 x 420 mm; 13.5 kg; 100 to 240 VAC, 50 to 60 Hz	Source
Handpiece	Single reusable PEEK handpiece; pre vacuum steam sterilisation	Source
Suction	Peristaltic pump or pinch valve model; pinch valve version needs an external vacuum	Source
FDA clearance	K173234 (January 2018), predicate LithoClast Master (K012445); later K181364, K181997, K191124, K230893; product code FEO	Source

Recalls

Recalls.

This note lists no recalls. Check the FDA recall database for the latest record.

Safety

Safety warnings from the record.

On the older LithoClast Ultra, a handpiece could dislodge and damage its cable with a shock risk; check handpiece cables on all LithoClast generations. Source
Indicated only for urinary tract stones in the kidney, ureter and bladder. Source

Sources

Where this note comes from.

Not covered: No FDA recall names the Trilogy; the two listed EMS lithotripsy recalls concern the older Master and Ultra and are used only as context. The Trilogy IFU was not opened, so error messages, handpiece reprocessing and power settings guidance are missing. The summary table prints the Trilogy ultrasound frequency as '24 Hz' marked 'same' as the predicate's 24 kHz, so 24 kHz is assumed.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

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