Cleared Traditional

K213381 - Physica system
(FDA 510(k) Clearance)

K213381 · Lima Corporate S.P.A. · Orthopedic

Dec 2021

Decision

65d

Days

Class 2

Risk

K213381 is an FDA 510(k) clearance for the Physica system, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Lima Corporate S.P.A. (San Daniele Del Friuli, IT). The FDA issued a Cleared decision on December 17, 2021, 65 days after receiving the submission on October 13, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K213381 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 13, 2021
Decision Date	December 17, 2021
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560