Cleared Traditional

K153721 - iTotal Cruciate Retaining (CR) Knee Rep...

K153721 is the FDA 510(k) clearance for iTotal Cruciate Retaining (CR) Knee Rep... by Conformis, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K153721 · Conformis, Inc. · Orthopedic device
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Mar 2016
Decision
88d
Days
Class 2
Risk

K153721 is an FDA 510(k) clearance for the iTotal Cruciate Retaining (CR) Knee Replacement System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Conformis, Inc. (Bedford, US). The FDA issued a Cleared decision on March 25, 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 Conformis, Inc. devices

Submission Details

510(k) Number K153721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2015
Decision Date March 25, 2016
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 786
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K153721.
EMPOWR PS Knee System
K160342 · Encore Medical, L.P. · May 2016
All Poly Tibial Component
K152430 · United Orthopedic Corporation · Apr 2016
Optetrak Logic Metaphyseal Cones
K153595 · Exactech, Inc. · Mar 2016
Optetrak Advanced Patella
K160484 · Exactech, Inc. · Mar 2016
iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System
K160025 · Conformis, Inc. · Mar 2016
ConforMIS iTotal Posterior Stabilized Knee Replacement System
K153217 · Conformis, Inc. · Jan 2016