Cleared Special

Physica Porous Femoral Components

K243615 · Lima Corporate S.P.A. · Orthopedic

Dec 2024

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K243615 is an FDA 510(k) clearance for the Physica Porous Femoral Components, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Lima Corporate S.P.A. (Villanova Di San Daniele, IT). The FDA issued a Cleared decision on December 18, 2024, 26 days after receiving the submission on November 22, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K243615 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565