Cleared Traditional

K152252 - Arthrex iBalance TKA System

K152252 is the FDA 510(k) clearance for Arthrex iBalance TKA System by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code MBH) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K152252 · Arthrex, Inc. · Orthopedic device
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Nov 2015
Decision
98d
Days
Class 2
Risk

K152252 is an FDA 510(k) clearance for the Arthrex iBalance TKA System. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on November 16, 2015 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 888.3565 - 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 Arthrex, Inc. devices

Submission Details

510(k) Number K152252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2015
Decision Date November 16, 2015
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.

Device Classification

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 123
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K152252.
Vanguard XP Knee System
K153657 · Biomet, Inc. · May 2016
Optetrak One Logic Femoral Components
K153776 · Exactech, Inc. · Mar 2016
Arthrex iBalance TKA System
K153586 · Arthrex, Inc. · Feb 2016
EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base
K152298 · Microport Orthopedics, Inc. · Nov 2015
U2 Femoral Component, CR, Porous Coated, Additional Sizes
K150832 · United Orthopedic Corporation · Sep 2015
Zimmer Persona Personalized Knee System
K150090 · Zimmer, Inc. · May 2015