Cleared Traditional

K030237 - KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT

K030237 is an FDA 510(k) clearance for KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT, manufactured by Kapp Surgical Instrument, Inc.. The device is a Class 2 Orthopedic device with product code KWI cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K030237 · Kapp Surgical Instrument, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
218d
Days
Class 2
Risk

K030237 is an FDA 510(k) clearance for the KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Kapp Surgical Instrument, Inc. (Warrensville, US). The FDA issued a Cleared decision on August 29, 2003 after a review of 218 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3170 - 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 - K030237

510(k) Number K030237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2003
Decision Date August 29, 2003
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWI Device Classification - Class 2, Special Controls

Product Code KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3170
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 - KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

All 22
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K030237.
ACUMED ANATOMIC RADIAL HEAD SYSTEM
K041858 · Acumed, LLC · Oct 2004
MODULAR RADIAL HEAD REPLACEMENT DEVICE
K040611 · Biomet, Inc. · Jun 2004
ASCENSION MODULAR RADIAL HEAD
K032686 · Ascension Orthopedics, Inc. · Oct 2003
EVOLVE CERAMIC RADIAL HEAD IMPLANT
K030384 · Wrightmedicaltechnologyinc · Aug 2003
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
K012551 · Biomet, Inc. · Jan 2002
TORNIER BIPOLAR RADIAL HEAD PROSTHESIS
K994041 · Tornier, Inc. · Aug 2000