Cleared Traditional

Zimmer® Persona® Personalized Knee System (K243293) - FDA 510(k) Clearance

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

K243293 · Zimmer Biomet · Orthopedic device
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Dec 2024
Decision
63d
Days
Class 2
Risk

K243293 is an FDA 510(k) clearance for the Zimmer® Persona® Personalized Knee System. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Zimmer Biomet (Warsaw, US). The FDA issued a Cleared decision on December 20, 2024 after a review of 63 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 Biomet devices

Submission Details

510(k) Number K243293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2024
Decision Date December 20, 2024
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 108
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K243293.
Physica System (Physica CR Porous Femoral components)
K250980 · Lima Corporate S.P.A. · May 2025
iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System
K243768 · Restor3D, Inc. · Mar 2025
Freedom® Total Knee System - Porous Tibial Base Plate
K241597 · Maxx Orthopedics, Inc. · Feb 2025
Physica Porous Femoral Components
K243615 · Lima Corporate S.P.A. · Dec 2024
Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)
K242543 · Zimmer, Inc. · Nov 2024
Agility Symmetric™ Total Knee System
K242412 · Medisurge, LLC · Nov 2024