Cleared Traditional

K131467 - ITOTAL CRUCIATE RETAINING (CR) KNEE REP...

K131467 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 58-day FDA review.

K131467 · Conformis, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
58d
Days
Class 2
Risk

K131467 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 July 18, 2013 after a review of 58 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 K131467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2013
Decision Date July 18, 2013
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 K131467.
GMK FULL PE TIBIAL COMPONENTS
K131310 · Medacta International · Aug 2013
EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
K122883 · Stelkast Company · Aug 2013
GMK REVISION EXTENSION
K123721 · Medacta International · Jul 2013
ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM
K131019 · Conformis, Inc. · May 2013
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
K123159 · Smith & Nephew, Inc. · May 2013
LOSPA TOTAL KNEE REPLACEMENT SYSTEM
K130673 · Corentec Co., Ltd. · Apr 2013