Cleared Traditional

K040497 - DISTAL RADIO-ULNAR JOINT IMPLANT

K040497 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 Traditional 510(k) pathway after a 335-day FDA review.

K040497 · Aptis Medical, LLC · Orthopedic device
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Jan 2005
Decision
335d
Days
Class 2
Risk

K040497 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 (Del Mar, US). The FDA issued a Cleared decision on January 26, 2005 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K040497

510(k) Number K040497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2004
Decision Date January 26, 2005
Days to Decision 335 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 122d · This submission: 335d
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 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 K040497.
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
WMT MODULAR ULNAR HEAD IMPLANT
K020274 · Wrightmedicaltechnologyinc · Feb 2002
ULNAR HEAD IMPLANT
K010786 · Avanta Orthopaedics, Inc. · Apr 2001