Cleared Traditional

NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI

K884789 · Protek, Inc. · Orthopedic
Feb 1989
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K884789 is an FDA 510(k) clearance for the NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI, a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II — Special Controls, product code KWL), submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 8, 1989, 85 days after receiving the submission on November 15, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K884789 FDA.gov
FDA Decision Cleared SN
Date Received November 15, 1988
Decision Date February 08, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code KWL — Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360

Similar Devices — KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 105
OsteoRemedies Hip Spacer System
K253675 · Osteoremedies, LLC · Dec 2025
InterSpace GV Hip Spacer
K252326 · Tecres S.P.A. · Aug 2025
Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
K242865 · Biocomposites, Ltd. · Jun 2025
COPAL? exchange G hip spacer; COPAL? G+V
K234028 · Heraeus Medical GmbH · Feb 2024
UHR Bipolar Implants, Restoration GAP II Implants
K222632 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Oct 2022
OsteoRemedies Hip Spacer System
K192995 · Osteoremedies, LLC · Jan 2020