Cleared Traditional

K153743 - PIEZOSURGERY PLUS

K153743 is an FDA 510(k) clearance for PIEZOSURGERY PLUS, manufactured by Mectron S.P.A.. The device is a Class 2 Orthopedic device with product code JDX cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K153743 · Mectron S.P.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
149d
Days
Class 2
Risk

K153743 is an FDA 510(k) clearance for the PIEZOSURGERY PLUS. Classified as Instrument, Surgical, Sonic And Accessory/attachment (product code JDX), Class II - Special Controls.

Submitted by Mectron S.P.A. (Carasco, IT). The FDA issued a Cleared decision on May 25, 2016 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4580 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Mectron S.P.A. devices

FDA 510(k) Submission Details - K153743

510(k) Number K153743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2015
Decision Date May 25, 2016
Days to Decision 149 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 122d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDX Device Classification - Class 2, Special Controls

Product Code JDX Instrument, Surgical, Sonic And Accessory/attachment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.4580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDX Instrument, Surgical, Sonic And Accessory/attachment

All 7
Devices cleared under the same product code (JDX) and FDA review panel - the closest regulatory comparables to K153743.
Ultrasonic Osteotomy Surgical System
K201274 · Smtp Technology Co., Ltd. · Feb 2021
XD880A Ultrasonic Osteotomy Surgical System
K172464 · Morley Research Consortium · Apr 2018
PIEZOELECTRIC SYSTEM
K100410 · Satelec · Apr 2010
ULTRA-DRIVE 3
K031280 · Biomet, Inc. · Sep 2003
ITM SONIC SURGERY SYSTEM
K912931 · Buckman Co., Inc. · Oct 1991
MODIFIED PROFILE HIP ACETABULAR PROSTHESIS
K891408 · Depuy, Inc. · Jun 1989