Cleared Traditional

Physica system

K210554 · Lima Corporate S.P.A. · Orthopedic

Apr 2021

Decision

40d

Days

Class 2

Risk

About This 510(k) Submission

K210554 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. (Udine, IT). The FDA issued a Cleared decision on April 6, 2021, 40 days after receiving the submission on February 25, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K210554 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 2021
Decision Date	April 06, 2021
Days to Decision	40 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