Cleared Traditional

K172464 - XD880A Ultrasonic Osteotomy Surgical System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172464 · Morley Research Consortium · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2018
Decision
253d
Days
Class 2
Risk

K172464 is an FDA 510(k) clearance for the XD880A Ultrasonic Osteotomy Surgical System. Classified as Instrument, Surgical, Sonic And Accessory/attachment (product code JDX), Class II - Special Controls.

Submitted by Morley Research Consortium (Atlanta, US). The FDA issued a Cleared decision on April 24, 2018 after a review of 253 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.

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Submission Details

510(k) Number K172464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2017
Decision Date April 24, 2018
Days to Decision 253 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
131d slower than avg
Panel avg: 122d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.