Cleared Traditional

K160700 - ATTUNE Revision Knee System

K160700 is an FDA 510(k) clearance for ATTUNE Revision Knee System, manufactured by Depuy(Ireland). The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K160700 · Depuy(Ireland) · Orthopedic device
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Jun 2016
Decision
88d
Days
Class 2
Risk

K160700 is an FDA 510(k) clearance for the ATTUNE Revision Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Depuy(Ireland) (Cork, IE). The FDA issued a Cleared decision on June 10, 2016 after a review of 88 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) devices

FDA 510(k) Submission Details - K160700

510(k) Number K160700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2016
Decision Date June 10, 2016
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
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 814
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K160700.
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All Poly Tibial Component
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