Cleared Traditional

ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS

K053587 · Ortho Development Corp. · Orthopedic

Mar 2006

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K053587 is an FDA 510(k) clearance for the ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on March 17, 2006, 84 days after receiving the submission on December 23, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K053587 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2005
Decision Date	March 17, 2006
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353