Cleared Traditional

K030237 - KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030237 · Kapp Surgical Instrument, Inc. · Orthopedic device
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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

Submission Details

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.

Device Classification

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 32
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K030237.
BioPoly Radial Head Implant
K233592 · BioPoly, LLC · Mar 2024
ALIGN Radial Head System
K231188 · Skeletal Dynamics, Inc. · Sep 2023
DePuy Synthes Radial Head Replacement System
K213563 · DePuy Synthes · Mar 2022
Avenger Radial Head System
K212872 · In2bones USA, LLC · Dec 2021
Avenger Radial Head System
K192754 · In2bones USA, LLC · Jan 2020