Cleared Traditional

K083284 - PIEZOSURGERY MEDICAL

K083284 is an FDA 510(k) clearance for PIEZOSURGERY MEDICAL, manufactured by Piezosurgery S.R.L.. The device is a Class 2 Orthopedic device with product code JDX cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K083284 · Piezosurgery S.R.L. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
152d
Days
Class 2
Risk

K083284 is an FDA 510(k) clearance for the PIEZOSURGERY MEDICAL. Classified as Instrument, Surgical, Sonic And Accessory/attachment (product code JDX), Class II - Special Controls.

Submitted by Piezosurgery S.R.L. (Rome, IT). The FDA issued a Cleared decision on April 8, 2009 after a review of 152 days - an extended review cycle.

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 - K083284

510(k) Number K083284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2008
Decision Date April 08, 2009
Days to Decision 152 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
30d slower than avg
Panel avg: 122d · This submission: 152d
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 21
Devices cleared under the same product code (JDX) and FDA review panel - the closest regulatory comparables to K083284.
PIEZOSURGERY FLEX
K132848 · Mectron S.P.A. · Nov 2013
PIEZOELECTRIC SYSTEM
K100410 · Satelec · Apr 2010
OSCAR 3
K093805 · Orthosonics, Ltd. · Feb 2010
OSCAR BONE RESECTOR
K083830 · Orthosonics, Ltd. · Mar 2009
LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)
K072961 · Sra Developments, Ltd. · Dec 2007
OSCAR, MODEL OE3000DB
K051053 · Orthosonics, Ltd. · Jul 2005
K083284 · PIEZOSURGERY MEDICAL
Download PDF FDA Summary Piezosurgery S.R.L.