Cleared Traditional

OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE

K984585 · Osteonics Corp. · Orthopedic
Feb 1999
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K984585 is an FDA 510(k) clearance for the OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE, a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II — Special Controls, product code KWL), submitted by Osteonics Corp. (Allendale,, US). The FDA issued a Cleared decision on February 24, 1999, 62 days after receiving the submission on December 24, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K984585 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1998
Decision Date February 24, 1999
Days to Decision 62 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

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