Cleared Traditional

K261458 - ATTUNE Total Knee System

Also marketed or referenced as:
ATTUNE Cementless Knee System

K261458 is an FDA 510(k) clearance for ATTUNE Total Knee System, 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 55-day FDA review.

K261458 · Depuy Ireland UC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
55d
Days
Class 2
Risk

K261458 is an FDA 510(k) clearance for the ATTUNE Total Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Depuy Ireland UC (Cork, IE). The FDA issued a Cleared decision on June 25, 2026 after a review of 55 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy Ireland UC devices

FDA 510(k) Submission Details - K261458

510(k) Number K261458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2026
Decision Date June 25, 2026
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 Consultant

Depuy Orthopaedics, Inc.
Paige Myers

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K261458.
ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)
K262251 · Globus Medical, Inc. · Jul 2026
NovoKnee (SteriKnee)
K261032 · NovoSource · Apr 2026
Materialise TKA Guide System
K253793 · Materialise NV · Jan 2026
EMPOWR Knee
K252974 · Encore Medical, L.P. · Dec 2025
ATTUNE™ Total Knee System
K253197 · Depuy Ireland UC · Nov 2025
Freedom Infinia™ Total Knee System
K253314 · Maxx Orthopedics, Inc. · Oct 2025