Cleared Traditional

K131845 - ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC

K131845 is an FDA 510(k) clearance for ACUMED ANATOMIC RADIAL HEAD SYSTEM, manufactured by Acumed, LLC. The device is a Class 2 Orthopedic device with product code KWI cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K131845 · Acumed, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
101d
Days
Class 2
Risk

K131845 is an FDA 510(k) clearance for the ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, A.... Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on September 30, 2013 after a review of 101 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 Acumed, LLC devices

FDA 510(k) Submission Details - K131845

510(k) Number K131845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2013
Decision Date September 30, 2013
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
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 31
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K131845.
Revolution Radial Head
K183618 · Ignite Orthopedics, Inc. · May 2019
Align Radial Head System
K172688 · Skeletal Dynamics, LLC · Dec 2017
AXIA RADIAL HEAD SYSTEM
K132735 · Imds (Innovative MEdical Device Systems) - Leis ME · Jan 2014
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
K112030 · Synthes (Usa), LLC · Jun 2012
ALIGN RADIAL HEAD SYSTEM
K092721 · Skeletal Dynamics, LLC · Aug 2010
SBI LATERAL RHEAD IMPLANT
K062898 · Small Bone Innovations, Inc. · Nov 2006