Cleared Traditional

ENCOMPASS 1017 AND 1217 EXTENDED PRESS-FIT HIP STEMS

K053293 · Ortho Development Corp. · Orthopedic

Feb 2006

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K053293 is an FDA 510(k) clearance for the ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on February 16, 2006, 83 days after receiving the submission on November 25, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K053293 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2005
Decision Date	February 16, 2006
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358