Cleared Special

K082839 - DISTAL RADIO-ULNAR JOINT IMPLANT

K082839 is an FDA 510(k) clearance for DISTAL RADIO-ULNAR JOINT IMPLANT, manufactured by Aptis Medical, LLC. The device is a Class 2 Orthopedic device with product code KXE cleared through the Special 510(k) pathway after a 28-day FDA review.

K082839 · Aptis Medical, LLC · Orthopedic device
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Oct 2008
Decision
28d
Days
Class 2
Risk

K082839 is an FDA 510(k) clearance for the 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 October 24, 2008 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aptis Medical, LLC devices

FDA 510(k) Submission Details - K082839

510(k) Number K082839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2008
Decision Date October 24, 2008
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 Peers - KXE Prosthesis, Wrist, Hemi-, Ulnar

All 12
Devices cleared under the same product code (KXE) and FDA review panel - the closest regulatory comparables to K082839.
Aptis Medical Distal Radio Ulnar Joint Implant
K190599 · Aptis Medical, LLC · May 2019
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