Cleared Traditional

K190599 - Aptis Medical Distal Radio Ulnar Joint Implant

K190599 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 56-day FDA review.

K190599 · Aptis Medical, LLC · Orthopedic device
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May 2019
Decision
56d
Days
Class 2
Risk

K190599 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 May 3, 2019 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aptis Medical, LLC devices

FDA 510(k) Submission Details - K190599

510(k) Number K190599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2019
Decision Date May 03, 2019
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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

Enmed Lntemtional, Inc.
Louise Focht

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 K190599.
Aptis Medical Distal Radio Ulnar Joint Implant
K142569 · Aptis Medical, LLC · Apr 2015
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