Cleared Traditional

EXPRT? Revision Hip System - EXPRT? Hip Distal Stem, EXPRT? Hip Standard Offset Proximal Body Implant, EXPRT? Hip Lateral Offset Proximal Body Implant, EXPRT? Hip Capture Bolt

K163497 · Encore Medical, L.P. · Orthopedic

Mar 2017

Decision

79d

Days

Class 2

Risk

About This 510(k) Submission

K163497 is an FDA 510(k) clearance for the EXPRT? Revision Hip System - EXPRT? Hip Distal Stem, EXPRT? Hip Standard Offset Proximal Body Implant, EXPRT? Hip Lateral Offset Proximal Body Implant, EXPRT? Hip Capture Bolt, a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (Class II — Special Controls, product code KWZ), submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on March 2, 2017, 79 days after receiving the submission on December 13, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3310.

Submission Details

510(k) Number	K163497 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2016
Decision Date	March 02, 2017
Days to Decision	79 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3310