DePuy Ireland UC P.F.C Sigma RP Knee System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

Johnson & Johnson International (Singapore) Pte Ltd

Class:

Class C medical device

Manufactured by:

DePuy Ireland UC

Therapeutic area:

Orthopaedics

Therapeutic indications:

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.

Product summary:

Device System Info:[Sterile Medical Device], Gamma Irradiation; Models: DePuy MBT Keel Tibial Tray Cemented Size 4 - 129433140, DePuy MBT Keel Tibial Tray Cemented Size 5 - 129433150, DePuy MBT Keel Tibial Tray Cemented Size 6 - 129433160, DePuy MBT Keel Tibial Tray Cemented Size 7 - 129433170, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 1 Cemented - 129431110, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 1.5 Cemented - 129431115, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 2 Cemented - 129431120, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 2.5 Cemented - 129431125, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 3 Cemented - 129431130, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 4 Cemented - 129431140, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 5 Cemented - 129431150, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 6 Cemented - 129431160, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 7 Cemented - 129431170, Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 1 Cementless - 129434110, Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 1.5 Cementless - 129434115, Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 2 Cementless - 129434120, Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 2.5 Cementless - 129434125, Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 3 Cementless - 129434130, Sigma RP Stabilized Insert Trial Sz 1.5 10.0mm - 973101, Sigma RP Stabilized Insert Trial Sz 1.5 12.5mm - 973102, Sigma RP Stabilized Insert Trial Sz 1.5 15.0mm - 973103, Sigma RP Stabilized Insert Trial Sz 1.5 17.5mm - 973104, Sigma RP Stabilized Insert Trial Sz 1.5 20.0mm - 973105, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2 10mm - 962111, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2 12.5mm - 962112, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2 15mm - 962113, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2 17.5mm - 962114, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 2 20mm - 962115, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 2 22.5mm - 962116, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 2 25mm - 962117, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2.5 10mm - 962121, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2.5 12.5mm - 962122, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2.5 15mm - 962123, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 2.5 17.5mm - 962124, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 2.5 20mm - 962125, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 2.5 22.5mm - 962126, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 2.5 25mm - 962127, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 3 10mm - 962131, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 3 12.5mm - 962132, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 3 15mm - 962133, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 3 17.5mm - 962134, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 3 20mm - 962135, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 3 22.5mm - 962136, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 3 25mm - 962137, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 4 10mm - 962141, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 4 12.5mm - 962142, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 4 15mm - 962143, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 4 17.5mm - 962144, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 4 20mm - 962145, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 4 22.5mm - 962146, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 4 25mm - 962147, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 5 10mm - 962151, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 5 12.5mm - 962152, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 5 15mm - 962153, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 5 17.5mm - 962154, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 5 20mm - 962155, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 5 22.5mm - 962156, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 5 25mm - 962157, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 6 10mm - 962161, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 6 12.5mm - 962162, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 6 15mm - 962163, P.F.C.® ∑ RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STab) 6 17.5mm - 962164, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 6 20mm - 962165, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 6 22.5mm - 962166, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 6 25mm - 962167, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 1.5 10mm - 972101, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 1.5 12.5mm - 972102, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 1.5 15mm - 972103, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 1.5 17.5mm - 972104, P.F.C. ® ∑ Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB) 1.5 20mm - 972105, DePuy MBT Keel Tibial Tray Cemented Size 1 - 129433110, DePuy MBT Keel Tibial Tray Cemented Size 1.5 - 129433115, DePuy MBT Keel Tibial Tray Cemented Size 2 - 129433120, DePuy MBT Keel Tibial Tray Cemented Size 2.5 - 129433125, DePuy MBT Keel Tibial Tray Cemented Size 3 - 129433130, Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 4 Cementless - 129434140, Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 5 Cementless - 129434150, Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 6 Cementless - 129434160, Sigma® LCS® Tibial Tray Rotating Platform MBT Keel Size 7 Cementless - 129434170, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 1 Cementless - 129432110, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 1.5 Cementless - 129432115, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 2 Cementless - 129432120, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 2.5 Cementless - 129432125, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 3 Cementless - 129432130, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 4 Cementless - 129432140, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 5 Cementless - 129432150, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 6 Cementless - 129432160, Sigma® LCS® Tibial Tray Rotating Platform MBT Cone Size 7 Cementless - 129432170, M.B.T. Tray Trial 1 - 229431110, M.B.T. Tray Trial 1.5 - 229431115, M.B.T. Tray Trial 2 - 229431120, M.B.T. Tray Trial 2.5 - 229431125, M.B.T. Tray Trial 3 - 229431130, M.B.T. Tray Trial 4 - 229431140, M.B.T. Tray Trial 5 - 229431150, M.B.T. Tray Trial 6 - 229431160, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2 10.0mm - 963011, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2 12.5mm - 963012, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2 15.0mm - 963013, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2 17.5mm - 963014, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2.5 10.0mm - 963021, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2.5 12.5mm - 963022, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2.5 15.0mm - 963023, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 2.5 17.5mm - 963024, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 3 10.0mm - 963031, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 3 12.5mm - 963032, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 3 15.0mm - 963033, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 3 17.5mm - 963034, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 4 10.0mm - 963041, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 4 12.5mm - 963042, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 4 15.0mm - 963043, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 4 17.5mm - 963044, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 5 10.0mm - 963051, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 5 12.5mm - 963052, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 5 15.0mm - 963053, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 5 17.5mm - 963054, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 6 10.0mm - 963061, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 6 12.5mm - 963062, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 6 15.0mm - 963063, P.F.C. ® Sigma RP Curved Tibial Insert Trial Sz 6 17.5mm - 963064, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 10.0mm - 963111, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 12.5mm - 963112, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 15mm - 963113, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 17.5mm - 963114, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 20mm - 963115, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 22.5mm - 963116, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2 25mm - 963117, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2.5 10.0mm - 963121, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2.5 12.5mm - 963122, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2.5 15mm - 963123, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2.5 17.5mm - 963124, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2.5 20mm - 963125, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 2.5 22.5mm - 963126, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 10.0mm - 963131, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 12.5mm - 963132, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 15mm - 963133, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 17.5mm - 963134, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 20mm - 963135, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 22.5mm - 963136, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 3 25mm - 963137, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 10.0mm - 963141, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 12.5mm - 963142, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 15mm - 963143, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 17.5mm - 963144, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 20mm - 963145, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 22.5mm - 963146, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 4 25mm - 963147, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 10.0mm - 963151, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 12.5mm - 963152, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 15mm - 963153, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 17.5mm - 963154, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 20mm - 963155, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 22.5mm - 963156, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 5 25mm - 963157, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 10.0mm - 963161, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 12.5mm - 963162, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 15mm - 963163, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 17.5mm - 963164, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 20mm - 963165, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 22.5mm - 963166, P.F.C.® Sigma RP Stabilized Tibial Insert Trial Sz 6 25mm - 963167

Authorization date:

2023-08-03