Cleared Traditional

K092721 - ALIGN RADIAL HEAD SYSTEM

K092721 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 Traditional 510(k) pathway after a 333-day FDA review.

K092721 · Skeletal Dynamics, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2010
Decision
333d
Days
Class 2
Risk

K092721 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 (Shelton, US). The FDA issued a Cleared decision on August 3, 2010 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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, LLC devices

FDA 510(k) Submission Details - K092721

510(k) Number K092721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2009
Decision Date August 03, 2010
Days to Decision 333 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
211d slower than avg
Panel avg: 122d · This submission: 333d
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 25
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K092721.
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
SBI LATERAL RHEAD IMPLANT
K062898 · Small Bone Innovations, Inc. · Nov 2006
EVOLVE MODULAR RADIAL HEAD
K060731 · Wrightmedicaltechnologyinc · Apr 2006
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
K051385 · Biomet, Inc. · Aug 2005