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About this product

Division: Knee Reconstruction
Category: Primary Knees

The SIGMA® Knee System offers one of today’s most comprehensive, integrated knee systems. Based on the clinically successful P.F.C® Total Knee System introduced in 1984, the SIGMA Knee continues a history on innovation based on clinical evidence.

The SIGMA Knee embraces a wide variety of surgeon philosophies and surgical techniques, while providing function, clinical results, and a variety of options for today’s patients. Available in posterior cruciate retaining or posterior stabilized femoral component designs, and fixed and mobile-bearing tibial component designs, this knee system is designed to provide surgical solutions for a variety of clinical indications.

The SIGMA® Knee System offers one of today’s most comprehensive, integrated knee systems.

Indications for Use

Total Knee Arthroplasty (TKA) and Unicompartmental Knee Replacement are intended to provide increased patient mobility and reduce pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The SIGMA Cruciate Retaining Knee femoral components with POROCOAT® Porous Coating are intended for cemented or cementless use as the femoral component of a Total Knee Replacement System. TKA is indicated for: a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or a failed previous implant. Unicompartmental Knee Replacement is indicated in these conditions if only one side of the joint (medial or lateral) is affected.

Features & Benefits

Features Benefits
Clinical Heritage • Based upon the clinically proven P.F.C.® Total Knee System, originally implanted in 1984
Fixed Bearing Technology • Highly polished cobalt chrome tibial tray provides smooth surface to minimize polyethylene wear1

• i2 locking mechanism with an interference fit for decreased micromotion2

• Features XLK polyethylene, a moderately cross-linked, oxidatively stable material
MBT Rotating Platform Technology • Rotational freedom to actively diffuse loosening forces3

• Self-aligning bearing is designed to decouple flexion-extension and rotation into two unidirectional motions

• Rotating platform tibial inserts available in AOX™ Polyethylene, featuring COVERNOX™ Antioxidant
AOX Polyethylene • COVERNOX Antioxidant stabilizes free radicals and prevents oxidation4

• Addition of an antioxidant eliminates the need for a heat treatment, thus maintains excellent mechanical properties4

• Moderate levels of cross-linking for wear performance similar to XLK
High Flexion • SIGMA RP-F Rotating Platform Knee accommodates 155 degrees of flexion with increased contact area in high flexion

• SIGMA CR150 Knee, available in fixed bearing or rotating platform options, accommodates 150 degrees of flexion.

1 Data on File at DePuy Orthopaedics, Inc. WR010120.
2 Leisinger, S., S. Hazebrouck and D. Deffenbaugh. "A New Approach to Micromotion Characterization of Modular Tibia Implants." 54th Annual Meeting of the Orthopaedic Research Society, Poster No. 1952, March 2-5, 2008, San Francisco, CA.

3 Bottlang, M., K.E. Oliver, E. Lacatusu, M.B. Sommers, O. Kessler. "A Mobile-bearing Knee Prosthesis Can Reduce Strain at the Proximal Tibia." Clinical Orthopaedics and Related Research. No. 447, pp. 105-111.
4 King, R. et al "Characterization of Gamma-Irradiated UHMWPE Stabilized with a Hindered Phenol Antioxidant." ORS Annual Meeting, 2009; Poster #19.

All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.
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