Cleared Traditional

K161592 - Persona Partial Knee System

K161592 is an FDA 510(k) clearance for Persona Partial Knee System, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K161592 · Biomet, Inc. · Orthopedic device
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Nov 2016
Decision
147d
Days
Class 2
Risk

K161592 is an FDA 510(k) clearance for the Persona Partial Knee System. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 3, 2016 after a review of 147 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K161592

510(k) Number K161592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2016
Decision Date November 03, 2016
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
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 K161592.
Bodycad Unicompartmental Knee System
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ZUK Select Knee System
K160738 · Smith & Nephew, Inc. · Jun 2016
JOURNEY II Uni Tibial Base and Insert
K152315 · Smith & Nephew, Inc. · Oct 2015
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K132640 · Conformis, Inc. · Dec 2013