Cleared Traditional

K211609 - ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert

K211609 is an FDA 510(k) clearance for ATTUNE Medial Stabilized (MS) Fixed Bea..., manufactured by Depuy Ireland UC. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K211609 · Depuy Ireland UC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2021
Decision
92d
Days
Class 2
Risk

K211609 is an FDA 510(k) clearance for the ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on August 25, 2021 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Depuy Ireland UC devices

FDA 510(k) Submission Details - K211609

510(k) Number K211609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2021
Decision Date August 25, 2021
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 885
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K211609.
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