Cleared Traditional

K142569 - Aptis Medical Distal Radio Ulnar Joint Implant (FDA 510(k) Clearance)

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

K142569 · Aptis Medical, LLC · Orthopedic device
Apr 2015
Decision
203d
Days
Class 2
Risk

K142569 is an FDA 510(k) clearance for the Aptis Medical Distal Radio Ulnar Joint Implant. Classified as Prosthesis, Wrist, Hemi-, Ulnar (product code KXE), Class II - Special Controls.

Submitted by Aptis Medical, LLC (Glenview, US). The FDA issued a Cleared decision on April 3, 2015 after a review of 203 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3810 - 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.

Submission Details

510(k) Number K142569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2014
Decision Date April 03, 2015
Days to Decision 203 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 116d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXE Prosthesis, Wrist, Hemi-, Ulnar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3810
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.