Cleared Traditional

ENCOMPASS 10/12 HIP STEM

K132697 · Ortho Development Corp. · Orthopedic

Jun 2014

Decision

295d

Days

Class 2

Risk

About This 510(k) Submission

K132697 is an FDA 510(k) clearance for the ENCOMPASS 10/12 HIP STEM, 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 June 20, 2014, 295 days after receiving the submission on August 29, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K132697 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2013
Decision Date	June 20, 2014
Days to Decision	295 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

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