Cleared Special

OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

K990203 · Osteonics Corp. · Orthopedic

Feb 1999

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K990203 is an FDA 510(k) clearance for the OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Osteonics Corp. (Allendale,, US). The FDA issued a Cleared decision on February 18, 1999, 28 days after receiving the submission on January 21, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K990203 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 1999
Decision Date	February 18, 1999
Days to Decision	28 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353