Cleared Traditional

InterSpace Knee Extra-Large Size, InterSpace Knee ATS

K181732 · Tecres S.P.A. · Orthopedic

Apr 2019

Decision

299d

Days

Class 2

Risk

About This 510(k) Submission

K181732 is an FDA 510(k) clearance for the InterSpace Knee Extra-Large Size, InterSpace Knee ATS, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Tecres S.P.A. (Sommacampagna, IT). The FDA issued a Cleared decision on April 27, 2019, 299 days after receiving the submission on July 2, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K181732 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2018
Decision Date	April 27, 2019
Days to Decision	299 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