Cleared Traditional

K132640 - IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM

K132640 is an FDA 510(k) clearance for IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM, manufactured by Conformis, Inc.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K132640 · Conformis, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
104d
Days
Class 2
Risk

K132640 is an FDA 510(k) clearance for the IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Conformis, Inc. (Bedford, US). The FDA issued a Cleared decision on December 5, 2013 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 - K132640

510(k) Number K132640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2013
Decision Date December 05, 2013
Days to Decision 104 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSX Device Classification - Class 2, Special Controls

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 111
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K132640.
Persona Partial Knee System
K161592 · Biomet, Inc. · Nov 2016
ZUK Select Knee System
K160738 · Smith & Nephew, Inc. · Jun 2016
JOURNEY II Uni Tibial Base and Insert
K152315 · Smith & Nephew, Inc. · Oct 2015
STRIDE UNICONDYLAR KNEE
K123380 · Blue Belt Technologies, Inc. · May 2013
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
K122529 · Zimmer, Inc. · Nov 2012
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K121974 · Conformis, Inc. · Sep 2012