Cleared Traditional

Arthrex iBalance BiCompartmental Arthroplasty System (K160461) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160461 · Arthrex, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2016
Decision
53d
Days
Class 2
Risk

K160461 is an FDA 510(k) clearance for the Arthrex iBalance BiCompartmental Arthroplasty System. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on April 12, 2016 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3540 - 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 Arthrex, Inc. devices

Submission Details

510(k) Number K160461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2016
Decision Date April 12, 2016
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3540
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 - KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

All 26
Devices cleared under the same product code (KRR) and FDA review panel - the closest regulatory comparables to K160461.
Overture Orthopaedics Patellofemoral System
K231253 · Overture Resurfacing, Inc. · Jul 2023
Episealer Patellofemoral System
K221048 · Episurf Medical, Inc. · Dec 2022
Avon Patello-femoral Joint Prosthesis
K211303 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jun 2021
MOTO PFJ System
K200122 · Medacta International S.A. · Apr 2020
Patello-Femoral Wave (Kahuna) Arthroplasty System
K181280 · Arthrosurface, Inc. · Jun 2018
Prelude PF Patellae
K143543 · Biomet, Inc. · Jan 2015