Cleared Traditional

K112030 - SYNTHES RADIAL HEAD PROSTHESIS SYSTEM

K112030 is the FDA 510(k) clearance for SYNTHES RADIAL HEAD PROSTHESIS SYSTEM by Synthes (Usa), LLC. It is a Class 2 Orthopedic device (product code KWI) cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K112030 · Synthes (Usa), LLC · Orthopedic device
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Jun 2012
Decision
340d
Days
Class 2
Risk

K112030 is an FDA 510(k) clearance for the SYNTHES RADIAL HEAD PROSTHESIS SYSTEM. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Synthes (Usa), LLC (West Chester, US). The FDA issued a Cleared decision on June 19, 2012 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Synthes (Usa), LLC devices

Submission Details

510(k) Number K112030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2011
Decision Date June 19, 2012
Days to Decision 340 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
218d slower than avg
Panel avg: 122d · This submission: 340d
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 21
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K112030.
Avenger Radial Head System
K192754 · In2bones USA, LLC · Jan 2020
Revolution Radial Head
K183618 · Ignite Orthopedics, Inc. · May 2019
ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC
K131845 · Acumed, LLC · Sep 2013
EVOLVE MODULAR RADIAL HEAD
K060731 · Wrightmedicaltechnologyinc · Apr 2006
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
K051385 · Biomet, Inc. · Aug 2005
ACUMED ANATOMIC RADIAL HEAD SYSTEM
K041858 · Acumed, LLC · Oct 2004