Cleared Special

K172688 - Align Radial Head System

K172688 is an FDA 510(k) clearance for Align Radial Head System, manufactured by Skeletal Dynamics, LLC. The device is a Class 2 Orthopedic device with product code KWI cleared through the Special 510(k) pathway after a 107-day FDA review.

K172688 · Skeletal Dynamics, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
107d
Days
Class 2
Risk

K172688 is an FDA 510(k) clearance for the Align Radial Head System. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Skeletal Dynamics, LLC (Miami, US). The FDA issued a Cleared decision on December 22, 2017 after a review of 107 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K172688

510(k) Number K172688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2017
Decision Date December 22, 2017
Days to Decision 107 days
Submission Type Special
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
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Modification to existing cleared device.

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 33
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K172688.
Avenger Radial Head System
K212872 · In2bones USA, LLC · Dec 2021
Avenger Radial Head System
K192754 · In2bones USA, LLC · Jan 2020
Revolution Radial Head
K183618 · Ignite Orthopedics, Inc. · May 2019
AXIA RADIAL HEAD SYSTEM
K132735 · Imds (Innovative MEdical Device Systems) - Leis ME · Jan 2014
ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC
K131845 · Acumed, LLC · Sep 2013
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
K112030 · Synthes (Usa), LLC · Jun 2012
K172688 · Align Radial Head System
Download PDF FDA Summary Skeletal Dynamics, LLC