Cleared Traditional

K133560 - ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM

K133560 is an FDA 510(k) clearance for ITOTAL CRUCIATE RETAINING KNEE REPLACME..., 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 128-day FDA review.

K133560 · Conformis, Inc. · Orthopedic device
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Mar 2014
Decision
128d
Days
Class 2
Risk

K133560 is an FDA 510(k) clearance for the ITOTAL CRUCIATE RETAINING KNEE REPLACMENT 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 28, 2014 after a review of 128 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 - K133560

510(k) Number K133560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2013
Decision Date March 28, 2014
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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 K133560.
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K140423 · Conformis, 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
VEGA KNEE SYSTEM
K140452 · Aesculap Implant Systems · Mar 2014
ULTRACONGRUENT INSERT
K132752 · United Orthopedic Corporation · Mar 2014
ARTHREX IBALANCE TKA SYSTEM
K133854 · Arthrex, Inc. · Feb 2014