Cleared Traditional

K201274 - Ultrasonic Osteotomy Surgical System

K201274 is an FDA 510(k) clearance for Ultrasonic Osteotomy Surgical System, manufactured by Smtp Technology Co., Ltd.. The device is a Class 2 Orthopedic device with product code JDX cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K201274 · Smtp Technology Co., Ltd. · Orthopedic device
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Feb 2021
Decision
283d
Days
Class 2
Risk

K201274 is an FDA 510(k) clearance for the Ultrasonic Osteotomy Surgical System. Classified as Instrument, Surgical, Sonic And Accessory/attachment (product code JDX), Class II - Special Controls.

Submitted by Smtp Technology Co., Ltd. (Zhangjiagang, CN). The FDA issued a Cleared decision on February 19, 2021 after a review of 283 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.

View all Smtp Technology Co., Ltd. devices

FDA 510(k) Submission Details - K201274

510(k) Number K201274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2020
Decision Date February 19, 2021
Days to Decision 283 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
161d slower than avg
Panel avg: 122d · This submission: 283d
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

Devices cleared under the same product code (JDX) and FDA review panel - the closest regulatory comparables to K201274.
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
ACE MOS SAW AND THE ACE MOS SPINE SAW
K862504 · Buckman Co., Inc. · Aug 1986