Cleared Traditional

K231188 - ALIGN Radial Head System

K231188 is an FDA 510(k) clearance for ALIGN Radial Head System, manufactured by Skeletal Dynamics, Inc.. The device is a Class 2 Orthopedic device with product code KWI cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K231188 · Skeletal Dynamics, Inc. · Orthopedic device
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Sep 2023
Decision
155d
Days
Class 2
Risk

K231188 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, Inc. (Miami, US). The FDA issued a Cleared decision on September 28, 2023 after a review of 155 days - an extended review cycle.

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 Skeletal Dynamics, Inc. devices

FDA 510(k) Submission Details - K231188

510(k) Number K231188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2023
Decision Date September 28, 2023
Days to Decision 155 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
33d slower than avg
Panel avg: 122d · This submission: 155d
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 20
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K231188.
Arthrex Radial Head Replacement System
K260624 · Arthrex, Inc. · Jul 2026
BioPoly Radial Head Implant
K233592 · BioPoly, LLC · Mar 2024
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