Cleared Special

K053119 - DISTAL RADIO-ULNAR JOINT IMPLANT

K053119 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 30-day FDA review.

K053119 · Aptis Medical, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
30d
Days
Class 2
Risk

K053119 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 (Louisville, US). The FDA issued a Cleared decision on December 7, 2005 after a review of 30 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.

FDA 510(k) Submission Details - K053119

510(k) Number K053119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2005
Decision Date December 07, 2005
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 15
Devices cleared under the same product code (KXE) and FDA review panel - the closest regulatory comparables to K053119.
ISOELASTICU
K081025 · Remi Sciences, Inc. · Nov 2008
DISTAL RADIO-ULNAR JOINT IMPLANT
K082839 · Aptis Medical, LLC · Oct 2008
SBI ULNAR HEAD IMPLANT
K061146 · Small Bone Innovations, Inc. · Jul 2006
ASCENSION MUH
K052137 · Ascension Orthopedics, Inc. · Nov 2005
DISTAL RADIO-ULNAR JOINT IMPLANT
K040497 · Aptis Medical, LLC · Jan 2005
HERBERT ULNAR HEAD PROSTHESIS SYSTEM
K042902 · Stuckenbrock Medizintechnik GmbH · Dec 2004
K053119 · DISTAL RADIO-ULNAR JOINT IMPLANT
Download PDF FDA Summary Aptis Medical, LLC