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DePuy Ireland UC P.F.C® Sigma Knee System - HSA Registration DE0508332

Access comprehensive regulatory information for DePuy Ireland UC P.F.C® Sigma 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 DE0508332 and owned by DePuy Ireland UC. The device was registered on July 26, 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
DE0508332
DePuy Ireland UC P.F.C® Sigma Knee System
HSA Registration Number: DE0508332
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Product Description

The P.F.C SIGMA Knee System is intended to replace articulating elements of a damaged knee joint where there is evidence of sufficient sound bone to seat and support the components. Indications: 1. A severely painful and/or arthritic joint due to osteoarthritis 2. Failed previous knee arthroplasty.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0508332
Registration Date
July 26, 2023
Change Notification Approval Date
July 30, 2024
Retention Due Date
July 25, 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 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 Sigma® Femoral Cruciate Substituting Cemented 4N Left Sigma® Femoral Cruciate Substituting Cemented 4N Right Sigam® Femoral Posterior Stabilized Cemented 1.5 Left Sigam® Femoral Posterior Stabilized Cemented 2 Left Sigam® Femoral Posterior Stabilized Cemented 2.5 Left Sigam® Femoral Posterior Stabilized Cemented 3 Left Sigam® Femoral Posterior Stabilized Cemented 4 Left Sigam® Femoral Posterior Stabilized Cemented 4N Left Sigam® Femoral Posterior Stabilized Cemented 5 Left Sigam® Femoral Posterior Stabilized Cemented 6 Left Sigam® Femoral Posterior Stabilized Cemented 1.5 Right Sigam® Femoral Posterior Stabilized Cemented 2 Right Sigam® Femoral Posterior Stabilized Cemented 2.5 Right Sigam® Femoral Posterior Stabilized Cemented 3 Right Sigam® Femoral Posterior Stabilized Cemented 4 Right Sigam® Femoral Posterior Stabilized Cemented 4N Right Sigam® Femoral Posterior Stabilized Cemented 5 Right Sigam® Femoral Posterior Stabilized Cemented 6 Right Sigam® Femoral Posterior Stabilized Lugged Cemented 2 Left Sigam® Femoral Posterior Stabilized Lugged Cemented 3 Left Sigam® Femoral Posterior Stabilized Lugged Cemented 4 Left Sigam® Femoral Posterior Stabilized Lugged Cemented 5 Left Sigam® Femoral Posterior Stabilized Lugged Cemented 6 Left Sigam® Femoral Posterior Stabilized Lugged Cemented 1.5 Left Sigam® Femoral Posterior Stabilized Lugged Cemented 2.5 Left Sigam® Femoral Posterior Stabilized Lugged Cemented 4N Left Sigam® Femoral Posterior Stabilized Lugged Cemented 2 Right Sigam® Femoral Posterior Stabilized Lugged Cemented 3 Right Sigam® Femoral Posterior Stabilized Lugged Cemented 4 Right Sigam® Femoral Posterior Stabilized Lugged Cemented 5 Right Sigam® Femoral Posterior Stabilized Lugged Cemented 6 Right Sigam® Femoral Posterior Stabilized Lugged Cemented 1.5 Right Sigam® Femoral Posterior Stabilized Lugged Cemented 2.5 Right Sigam® Femoral Posterior Stabilized Lugged Cemented 4N Right Sigma® Femoral Cruciate Substituting Cemented 2 Left Sigma® Femoral Cruciate Substituting Cemented 3 Left Sigma® Femoral Cruciate Substituting Cemented 4 Left Sigma® Femoral Cruciate Substituting Cemented 5 Left Sigma® Femoral Cruciate Substituting Cemented 6 Left Sigma® Femoral Cruciate Substituting Cemented 1.5 Left Sigma® Femoral Cruciate Substituting Cemented 2.5 Left Sigma® Femoral Cruciate Substituting Cemented 2 Right Sigma® Femoral Cruciate Substituting Cemented 3 Right Sigma® Femoral Cruciate Substituting Cemented 4 Right Sigma® Femoral Cruciate Substituting Cemented 5 Right Sigma® Femoral Cruciate Substituting Cemented 6 Right Sigma® Femoral Cruciate Substituting Cemented 1.5 Right Sigma® Femoral Cruciate Substituting Cemented 2.5 Right Sigma® Oval Dome Patella 3-Peg 32mm Cemented Sigma® Oval Dome Patella 3-Peg 35mm Cemented Sigma® Oval Dome Patella 3-Peg 38mm Cemented Sigma® Oval Dome Patella 3-Peg 41mm Cemented Sigma® Round Dome Patella 3-Peg 32mm Cemented Sigma® Round Dome Patella 3-Peg 35mm Cemented Sigma® Round Dome Patella 3-Peg 38mm Cemented Sigma® Round Dome Patella 3-Peg 41mm Cemented PFC® Sigma® Inset Patella 25mm Cemented PFC® Sigma® Inset Patella 28mm Cemented PFC® Sigma® Inset Patella 32mm Cemented 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. ® ∑ 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
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 196004400 196005400 196040150 196040200 196040250 196040300 196040400 196040450 196040500 196040600 196050150 196050200 196050250 196050300 196050400 196050450 196050500 196050600 196062500 196063500 196064500 196065500 196066500 196067500 196068500 196069500 196072500 196073500 196074500 196075500 196076500 196077500 196078500 196079500 960042 960043 960044 960045 960046 960047 960048 960052 960053 960054 960055 960056 960057 960058 960100 960101 960102 960103 960110 960111 960112 960113 960120 960121 960122 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 972101 972102 972103 972104 972105