Cleared Traditional

K140423 - ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

K140423 is an FDA 510(k) clearance for ITOTAL CRUCIATE RETAINING (CR) KNEE REP..., manufactured by Conformis, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K140423 · Conformis, Inc. · Orthopedic device
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May 2014
Decision
98d
Days
Class 2
Risk

K140423 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 May 27, 2014 after a review of 98 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 Conformis, Inc. devices

FDA 510(k) Submission Details - K140423

510(k) Number K140423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2014
Decision Date May 27, 2014
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 887
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K140423.
ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
K140833 · Conformis, Inc. · Jun 2014
U2 FEMORAL COMPONENT, CR, CEMENTED
K140073 · United Orthopedic Corp. · Jun 2014
JOURNEY II BCS CONSTRAINED INSERTS
K140555 · Smith & Nephew, Inc. · May 2014
ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER
K140027 · Materialise NV · May 2014
KLASSIC KNEE TIBIAL STEM EXTENSION
K140942 · Total Joint Orthopedics, Inc. · May 2014
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
K133560 · Conformis, Inc. · Mar 2014