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DePuy Ireland UC P.F.C Sigma® RP Knee System - HSA Registration DE0508358

Access comprehensive regulatory information for DePuy Ireland UC P.F.C Sigma® RP Knee System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508358 and owned by DePuy Ireland UC. The device was registered on August 03, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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HSA Official Data
CLASS C
DE0508358
DePuy Ireland UC P.F.C Sigma® RP Knee System
HSA Registration Number: DE0508358
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Product Description

When used with compatible femoral components, the knee system is indicated for cemented use in cases of osteoarthritis and rheumatoid arthritis. The porous coated Keeled and Non Keeled M.B.T.™ (Mobile Bearing Tibial) Tray configurations of the LCS Total Knee System are indicated for non-cemented use in skeletally mature individuals undergoing primary surgery for reconstructing knees damaged as a result of noninflammatory degenerative joint disease (NIDJD) or either of its composite diagnoses of osteoarthritis and post-traumatic arthritis pathologies. The Rotating Platform device configuration is indicated for use in knees whose anterior and posterior cruciate ligaments are absent or are in such condition as to justify their sacrifice. The P.F.C. Sigma RP Curved bearings when used with the P.F.C. Sigma Cruciate Retaining femoral component can be used in posterior cruciate ligament retaining procedures.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0508358
Registration Date
August 03, 2023
Change Notification Approval Date
October 23, 2024
Retention Due Date
August 02, 2025
Product Owner
Short Name
DePuy Ireland UC
Address
Loughbeg, Ringaskiddy, Co. Cork, Ireland, IRELAND
Registrant
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model Information
Model Name(s)
Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 1 Cemented Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 1.5 Cemented Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 2 Cemented Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 2.5 Cemented Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 3 Cemented Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 4 Cemented Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 5 Cemented Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 6 Cemented Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 7 Cemented Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 1 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 1.5 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 2 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 2.5 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 3 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 4 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 5 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 6 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 7 Cementless DePuy MBT Keel Tibial Tray Cemented Size 1 DePuy MBT Keel Tibial Tray Cemented Size 1.5 DePuy MBT Keel Tibial Tray Cemented Size 2 DePuy MBT Keel Tibial Tray Cemented Size 2.5 DePuy MBT Keel Tibial Tray Cemented Size 3 DePuy MBT Keel Tibial Tray Cemented Size 4 DePuy MBT Keel Tibial Tray Cemented Size 5 DePuy MBT Keel Tibial Tray Cemented Size 6 DePuy MBT Keel Tibial Tray Cemented Size 7 Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 1 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 1.5 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 2 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 2.5 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 3 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 4 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 5 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 6 Cementless Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 7 Cementless M.B.T. Tray Trial 1 M.B.T. Tray Trial 1.5 M.B.T. Tray Trial 2 M.B.T. Tray Trial 2.5 M.B.T. Tray Trial 3 M.B.T. Tray Trial 4 M.B.T. Tray Trial 5 M.B.T. Tray Trial 6 P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2 10mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2 12.5mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2 15mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2 17.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 2 20mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 2 22.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 2 25mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2.5 10mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2.5 12.5mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2.5 15mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2.5 17.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 2.5 20mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 2.5 22.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 2.5 25mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 3 10mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 3 12.5mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 3 15mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 3 17.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 3 20mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 3 22.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 3 25mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 4 10mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 4 12.5mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 4 15mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 4 17.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 4 20mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 4 22.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 4 25mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 5 10mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 5 12.5mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 5 15mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 5 17.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 5 20mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 5 22.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 5 25mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 6 10mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 6 12.5mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 6 15mm P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 6 17.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 6 20mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 6 22.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 6 25mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2 10.0mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2 12.5mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2 15.0mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2 17.5mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2.5 10.0mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2.5 12.5mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2.5 15.0mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2.5 17.5mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 3 10.0mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 3 12.5mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 3 15.0mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 3 17.5mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 4 10.0mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 4 12.5mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 4 15.0mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 4 17.5mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 5 10.0mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 5 12.5mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 5 15.0mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 5 17.5mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 6 10.0mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 6 12.5mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 6 15.0mm P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 6 17.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 10.0mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 12.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 15mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 17.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 20mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 22.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 25mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2.5 10.0mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2.5 12.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2.5 15mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2.5 17.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2.5 20mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2.5 22.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 10.0mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 12.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 15mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 17.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 20mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 22.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 25mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 10.0mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 12.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 15mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 17.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 20mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 22.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 25mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 10.0mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 12.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 15mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 17.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 20mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 22.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 25mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 10.0mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 12.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 15mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 17.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 20mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 22.5mm P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 25mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 1.5 10mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 1.5 12.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 1.5 15mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 1.5 17.5mm P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 1.5 20mm Sigma RP Stabilized Insert Trial Sz 1.5 10.0mm Sigma RP Stabilized Insert Trial Sz 1.5 12.5mm Sigma RP Stabilized Insert Trial Sz 1.5 15.0mm Sigma RP Stabilized Insert Trial Sz 1.5 17.5mm Sigma RP Stabilized Insert Trial Sz 1.5 20.0mm
Model Identifier(s)
129431110 129431115 129431120 129431125 129431130 129431140 129431150 129431160 129431170 129432110 129432115 129432120 129432125 129432130 129432140 129432150 129432160 129432170 129433110 129433115 129433120 129433125 129433130 129433140 129433150 129433160 129433170 129434110 129434115 129434120 129434125 129434130 129434140 129434150 129434160 129434170 229431110 229431115 229431120 229431125 229431130 229431140 229431150 229431160 962111 962112 962113 962114 962115 962116 962117 962121 962122 962123 962124 962125 962126 962127 962131 962132 962133 962134 962135 962136 962137 962141 962142 962143 962144 962145 962146 962147 962151 962152 962153 962154 962155 962156 962157 962161 962162 962163 962164 962165 962166 962167 963011 963012 963013 963014 963021 963022 963023 963024 963031 963032 963033 963034 963041 963042 963043 963044 963051 963052 963053 963054 963061 963062 963063 963064 963111 963112 963113 963114 963115 963116 963117 963121 963122 963123 963124 963125 963126 963131 963132 963133 963134 963135 963136 963137 963141 963142 963143 963144 963145 963146 963147 963151 963152 963153 963154 963155 963156 963157 963161 963162 963163 963164 963165 963166 963167 972101 972102 972103 972104 972105 973101 973102 973103 973104 973105