Cleared Traditional

K142569 - Aptis Medical Distal Radio Ulnar Joint Implant

K142569 is an FDA 510(k) clearance for Aptis Medical Distal Radio Ulnar Joint ..., manufactured by Aptis Medical, LLC. The device is a Class 2 Orthopedic device with product code KXE cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K142569 · Aptis Medical, LLC · Orthopedic device
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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.

View all Aptis Medical, LLC devices

FDA 510(k) Submission Details - K142569

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 122d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXE Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Aquila Consultants, LLC
Bryan Babb

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 - KXE Prosthesis, Wrist, Hemi-, Ulnar

All 11
Devices cleared under the same product code (KXE) and FDA review panel - the closest regulatory comparables to K142569.
Aptis Medical Distal Radio Ulnar Joint Implant
K190599 · Aptis Medical, LLC · May 2019
FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
K112481 · Ascension Orthopedic · Apr 2012
SBI ULNAR HEAD IMPLANT
K061146 · Small Bone Innovations, Inc. · Jul 2006
DISTAL RADIO-ULNAR JOINT IMPLANT
K053119 · Aptis Medical, LLC · Dec 2005
ASCENSION MUH
K052137 · Ascension Orthopedics, Inc. · Nov 2005
HERBERT ULNAR HEAD PROSTHESIS SYSTEM
K042902 · Stuckenbrock Medizintechnik GmbH · Dec 2004