Cleared Traditional

Physica system

K201084 · Lima Corporate S.P.A. · Orthopedic

Dec 2020

Decision

235d

Days

Class 2

Risk

About This 510(k) Submission

K201084 is an FDA 510(k) clearance for the Physica system, 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. (San Daniele Del Friuli, IT). The FDA issued a Cleared decision on December 14, 2020, 235 days after receiving the submission on April 23, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K201084 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2020
Decision Date	December 14, 2020
Days to Decision	235 days
Submission Type	Traditional
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