Cleared Traditional

K163610 - PIEZOTOME M+, PIEZOTOME M+ Handpiece

K163610 is an FDA 510(k) clearance for PIEZOTOME M+, manufactured by Satalec-Acteon Group. The device is a Class 2 Orthopedic device with product code JDX cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K163610 · Satalec-Acteon Group · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
148d
Days
Class 2
Risk

K163610 is an FDA 510(k) clearance for the PIEZOTOME M+, PIEZOTOME M+ Handpiece. Classified as Instrument, Surgical, Sonic And Accessory/attachment (product code JDX), Class II - Special Controls.

Submitted by Satalec-Acteon Group (Merignac, FR). The FDA issued a Cleared decision on May 19, 2017 after a review of 148 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.

FDA 510(k) Submission Details - K163610

510(k) Number K163610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2016
Decision Date May 19, 2017
Days to Decision 148 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 122d · This submission: 148d
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 Consultant

Satelec - Acteon Group
Argie Zoubroulis

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 20
Devices cleared under the same product code (JDX) and FDA review panel - the closest regulatory comparables to K163610.
Ultrasonic Osteotomy Surgical System
K201274 · Smtp Technology Co., Ltd. · Feb 2021
XD880A Ultrasonic Osteotomy Surgical System
K172464 · Morley Research Consortium · Apr 2018
PIEZOSURGERY PLUS
K153743 · Mectron S.P.A. · May 2016
PIEZOSURGERY FLEX
K132848 · Mectron S.P.A. · Nov 2013
PIEZOELECTRIC SYSTEM
K100410 · Satelec · Apr 2010
OSCAR 3
K093805 · Orthosonics, Ltd. · Feb 2010
K163610 · PIEZOTOME M+, PIEZOTOME M+ Handpiece
Download PDF FDA Summary Satalec-Acteon Group