Medical Device Division · registration 160005Active

Smith & Nephew

Name: Smith & Nephew — Medical Device Division 160005
Creator: Smith & Nephew, Inc.
Keywords: Smith & Nephew, Smith & Nephew, 160005, Prostheses, Joint, Knee, Total, Medical Device Division

Hong KongProstheses, Joint, Knee, TotalClass IIISmith & Nephew, Inc.

Verified

Official record identity

MDACS listing number: 160005
Model name: Legion Oxinium Cemented Posterior Stabilized Femorals (71421202, 71421203, 71421204, 71421205, 71421206, 71421212, 71421213, 71421214, 71421215, 71421216), Legion CoCr Cemented Posterior Stabilized Femorals (71423232, 71423233, 71423234, 71423235, 71423236, 71423222, 71423223, 71423224, 71423225, 71423226), Genesis II Patella (71420566, 71420568, 71420570, 71420572, 71420574, 71420576, 71420578, 71420580), Genesis II Posterior Stabilized High Flexion Articular Inserts (71421501, 71421502, 71421503, 71421504, 71421505, 71421506, 71421507, 71421508, 71421509, 71421510, 71421511, 71421512, 71421513, 71421514, 71421515, 71421516, 71421517, 71421518, 71421519, 71421520, 71421521, 71421522, 71421523, 71421524, 71421525, 71421526, 71421527, 71421528), Genesis II Cemented Tibial Bases (71420160, 71420162, 71420164, 71420166, 71420168, 71420170, 71420172, 71420174, 71420176, 71420180, 71420182, 71420184, 71420186, 71420188, 71420190, 71420191), Genesis II Cemented Posterior Stabilized Femorals (71420096, 71420098, 71420100, 71420102, 71420104, 71420106, 71420108, 71420110, 71420112, 71420114, 71420116, 71420118, 71420120, 71420122, 71420124, 71420126), Genesis II Oxinium Posterior Stabilized Femorals (71421012, 71421013, 71421014, 71421015, 71421016, 71421112, 71421113, 71421114, 71421115, 71421116)
Registration date: August 28, 2025
Expiry date: January 31, 2031
Source update date: September 02, 2026
Status: Active

Classification

Risk class: Class III
Published category: Prostheses, Joint, Knee, Total

Published parties

Registrant / registration holder: Smith & Nephew Limited
Manufacturer: Smith & Nephew, Inc.

Official description

Prostheses, Joint, Knee, Total

Additional source fields

AMD nomenclature code: 16096
Traditional Chinese local responsible person: 施樂輝有限公司
Local responsible person phone: 26487700
Published manufacturer address: 1450 Brooks Road, Memphis, Tennessee, 38116, USA
Revision number: d

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.