Cleared Special

K243615 - Physica Porous Femoral Components

K243615 is the FDA 510(k) clearance for Physica Porous Femoral Components by Lima Corporate S.P.A.. It is a Class 2 Orthopedic device (product code MBH) cleared through the Special 510(k) pathway after a 26-day FDA review.

K243615 · Lima Corporate S.P.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
26d
Days
Class 2
Risk

K243615 is an FDA 510(k) clearance for the Physica Porous Femoral Components. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Lima Corporate S.P.A. (Villanova Di San Daniele, IT). The FDA issued a Cleared decision on December 18, 2024 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lima Corporate S.P.A. devices

Submission Details

510(k) Number K243615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2024
Decision Date December 18, 2024
Days to Decision 26 days
Submission Type Special
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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 K243615.
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
Zimmer® Persona® Personalized Knee System
K243293 · Zimmer Biomet · 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
Persona the Personalized Knee System
K243247 · Zimmer, Inc. · Oct 2024