Cleared Special

Align Radial Head System (K172688) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K172688 · Skeletal Dynamics, LLC · Orthopedic device
Download Printable Device Report (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.

View all Skeletal Dynamics, LLC devices

Submission Details

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
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Modification to existing cleared device.

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 K172688.
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
Revolution Radial Head
K183618 · Ignite Orthopedics, Inc. · May 2019