Cleared Traditional

K132735 - AXIA RADIAL HEAD SYSTEM

K132735 is an FDA 510(k) clearance for AXIA RADIAL HEAD SYSTEM, manufactured by Imds (Innovative MEdical Device Systems) - Leis ME. The device is a Class 2 Orthopedic device with product code KWI cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K132735 · Imds (Innovative MEdical Device Systems) - Leis ME · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
126d
Days
Class 2
Risk

K132735 is an FDA 510(k) clearance for the AXIA RADIAL HEAD SYSTEM. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Imds (Innovative MEdical Device Systems) - Leis ME (Orlando, US). The FDA issued a Cleared decision on January 7, 2014 after a review of 126 days - within the typical 510(k) review window.

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 Imds (Innovative MEdical Device Systems) - Leis ME devices

FDA 510(k) Submission Details - K132735

510(k) Number K132735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2013
Decision Date January 07, 2014
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
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 30
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K132735.
Avenger Radial Head System
K192754 · In2bones USA, LLC · Jan 2020
Revolution Radial Head
K183618 · Ignite Orthopedics, Inc. · May 2019
Align Radial Head System
K172688 · Skeletal Dynamics, LLC · Dec 2017
ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC
K131845 · Acumed, LLC · Sep 2013
ALIGN RADIAL HEAD SYSTEM
K092721 · Skeletal Dynamics, LLC · Aug 2010
SBI LATERAL RHEAD IMPLANT
K062898 · Small Bone Innovations, Inc. · Nov 2006