Cleared Traditional

K242543 - Persona the Personalized Knee System (P...

K242543 is the FDA 510(k) clearance for Persona the Personalized Knee System (P... by Zimmer, Inc.. It is a Class 2 Orthopedic device (product code MBH) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K242543 · Zimmer, Inc. · Orthopedic device
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Nov 2024
Decision
88d
Days
Class 2
Risk

K242543 is an FDA 510(k) clearance for the Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs). Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 22, 2024 after a review of 88 days - a notably fast clearance cycle.

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: 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 Zimmer, Inc. devices

Submission Details

510(k) Number K242543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2024
Decision Date November 22, 2024
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 K242543.
Freedom® Total Knee System - Porous Tibial Base Plate
K241597 · Maxx Orthopedics, Inc. · Feb 2025
Zimmer® Persona® Personalized Knee System
K243293 · Zimmer Biomet · Dec 2024
Physica Porous Femoral Components
K243615 · Lima Corporate S.P.A. · Dec 2024
Agility Symmetric™ Total Knee System
K242412 · Medisurge, LLC · Nov 2024
Persona the Personalized Knee System
K243247 · Zimmer, Inc. · Oct 2024
Exactech® TRULIANT® Knee System
K240393 · Exactech, Inc. · Oct 2024