Cleared Traditional

K170808 - Unity Total Knee System

K170808 is an FDA 510(k) clearance for Unity Total Knee System, manufactured by Corin U.S.A. Limited. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K170808 · Corin U.S.A. Limited · Orthopedic device
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Jul 2017
Decision
118d
Days
Class 2
Risk

K170808 is an FDA 510(k) clearance for the Unity Total Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Corin U.S.A. Limited (Tampa, US). The FDA issued a Cleared decision on July 13, 2017 after a review of 118 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 Corin U.S.A. Limited devices

FDA 510(k) Submission Details - K170808

510(k) Number K170808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2017
Decision Date July 13, 2017
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
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 836
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K170808.
EVOLUTION Revision CCK System
K171389 · Microport Orthopedics, Inc. · Aug 2017
Biomet Knee Joint Replacement Prostheses
K171054 · Biomet, Inc. · Jul 2017
Genius Total Knee System
K170613 · Signature Orthopaedics Pty, Ltd. · Jul 2017
Empowr CR Knee Tibial Insert
K170573 · Encore Medical, L.P. · May 2017
Smith & Nephew VISIONAIRE Adaptive Guides
K170282 · Smith & Nephew, Inc. · May 2017
ANTHEM CR Total Knee System
K170648 · Smith & Nephew, Inc. · May 2017