Cleared Traditional

AMF Revision TT Cones

K200653 · Lima Corporate S.P.A. · Orthopedic

May 2020

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K200653 is an FDA 510(k) clearance for the AMF Revision TT Cones, 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 May 7, 2020, 56 days after receiving the submission on March 12, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K200653 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 12, 2020
Decision Date	May 07, 2020
Days to Decision	56 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