Cleared Traditional

All Poly Tibial Component

K152430 · United Orthopedic Corporation · Orthopedic

Apr 2016

Decision

230d

Days

Class 2

Risk

About This 510(k) Submission

K152430 is an FDA 510(k) clearance for the All Poly Tibial Component, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by United Orthopedic Corporation (Hsinchu, TW). The FDA issued a Cleared decision on April 12, 2016, 230 days after receiving the submission on August 26, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K152430 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2015
Decision Date	April 12, 2016
Days to Decision	230 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