Cleared Traditional

K033930 - KAPP CUSTOM ULNAR HEAD WRIST IMPLANT

K033930 is an FDA 510(k) clearance for KAPP CUSTOM ULNAR HEAD WRIST IMPLANT, manufactured by Kapp Surgical Instrument, Inc.. The device is a Class 2 Orthopedic device with product code KXE cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K033930 · Kapp Surgical Instrument, Inc. · Orthopedic device
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Jul 2004
Decision
223d
Days
Class 2
Risk

K033930 is an FDA 510(k) clearance for the KAPP CUSTOM ULNAR HEAD WRIST IMPLANT. Classified as Prosthesis, Wrist, Hemi-, Ulnar (product code KXE), Class II - Special Controls.

Submitted by Kapp Surgical Instrument, Inc. (Warrensville, US). The FDA issued a Cleared decision on July 28, 2004 after a review of 223 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 Kapp Surgical Instrument, Inc. devices

FDA 510(k) Submission Details - K033930

510(k) Number K033930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2003
Decision Date July 28, 2004
Days to Decision 223 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
101d slower than avg
Panel avg: 122d · This submission: 223d
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 14
Devices cleared under the same product code (KXE) and FDA review panel - the closest regulatory comparables to K033930.
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
ULNAR HEAD IMPLANT
K982268 · Avanta Orthopaedics, Inc. · Dec 1998