Foundation Knee
28Pages

DJO Surgical Knee Systems Encore Medical, L.P. 9800 Metric Blvd. Austin, TX 78758 0400-0034 Rev. ZB 2020-12 A printable copy of the IFU for this device can be located at: www.djosurgicalifus.com. A paper copy can be requested via phone at +1-800-520-8976. EN 1. Product Handling Implants are provided sterile and should always be stored unopened in their respective protective containers. Prior to use, inspect package for damage that may compromise sterility. If packaging has been opened or damaged upon receipt, contact the manufacturer’s representative. Also inspect the labeling to verify that the expiration date has not passed. If the product is expired, contact Customer Service and do not use the implant. When unpacking the implant, verify the labeling for correct Reference No. and size. When removing the implant from its packaging, the

relevant aseptic instructions must be observed. Protect prosthesis from contact with objects that may damage the surface finish. Inspect each implant prior to use for visual damage. This implant is part of a system and should be used only in combination with other original DJO Surgical® product belonging to the same knee system, unless otherwise specified. 2. Product Description and Implant Materials Applicable ASTM Standard Fixation Method CoCrMo Porous Coating Foundation® Knee System FOUNDATION® Femur (Primary1, Posterior Stabilized2, Revision Posterior Stabilized2) FOUNDATION® Porous...

FOUNDATION® Tibia Stemmed, Nonporous, Primary FK/3DKNEE™ Downsize Tibial Baseplate FOUNDATION® Tibia Stemmed, Nonporous, Revision with Tibial Stem Plug FOUNDATION® Porous Coated Tibia Stemmed-no Holes FK/3DKNEE™ Porous Coated Downsize Tibia FOUNDATION® Tibial Inserts (Primary1, Ultracongruent1, Posterior Stabilized2, Constrained PS2) with Attachment Screw FOUNDATION® Porous Coated Tibia Stemmed Medical grade UltraHigh Molecular Weight Polyethylene

FOUNDATION® Modular Spacer Blocks (Femoral4, Tibial) 1. Size interchangeability between the FOUNDATION® Primary or Porous femur and Ultra-congruent tibial inserts is limited to one size larger and one size smaller. Primary inserts to be used with Primary or Porous femur. 2. Size interchangeability between the FOUNDATION® Posterior-Stabilized or Revision PS femur and Posterior-Stabilized or Constrained PS tibial insert is limited to one size larger and one size smaller. 3. FOUNDATION® stem extensions are compatible with Revision femurs and Revision tibias and are available in various lengths...

3DKNEE™ Tibial Baseplate FK/3DKNEE™ Downsize Tibial Baseplate 3DKNEE™ Porous Coated Tibial Baseplate FK/3DKNEE™ Porous Coated Downsize Tibial Baseplate 3DKNEE™ Insert (Standard, DCM) with Attachment Screw Medical grade UltraHigh Molecular Weight Polyethylene

Medical grade UltraHigh Molecular Weight Polyethylene (Moderately CrossLinked) Vitamin E UHMWPE (a-tocopheral) with Attachment Screw ASTM F648 / ASTM F2565 ASTM F2695 1. 3DKNEE™ femurs are to be used with 3DKNEE™ tibial inserts and FK/3DKNEE™, FOUNDATION® or 3DKNEE™ tibial baseplates. If using FK/3DKNEE™ or FOUNDATION® tibial baseplates with 3DKNEE™ femurs, use baseplates that are one size smaller. 2. Size 3, 5, and 7 3DKNEE™ femurs and inserts are to be used with 3DKNEE™ Tibial Components that are one size larger or FOUNDATION® or FK/3DKNEE™ downsize components that are one size smaller....

CoCrMo Cementless CoCrMo Porous Coating EMPOWR™ Universal Tibial Baseplate with Stem Plug EMPOWR™ Universal Cemented Stem Extension EMPOWR Porous® Tibial Baseplate EMPOWR™ Tibial Base

EMPOWR™ Universal Tibial Augment5 - Half Block, 5mm (with 5mm screw) EMPOWR™ Universal Tibial Augment Screw, (5mm, 10mm, 15mm) 5 EMPOWR™ Tibial Insert: - EMPOWR 3D™ Tibial Insert - e+™, 1 - EMPOWR PS™ Tibial Insert - e+™, 2 - EMPOWR CR® Tibial Insert - e+™, 4 - EMPOWR VVC® Tibial Insert - e+™, 3 (10mm through 19mm)3 Medical grade UltraHigh Molecular Weight Polyethylene (Moderately CrossLinked) Vitamin E UHMWPE (atocoph

EMPOWR™ Tibial Insert: - EMPOWR VVC® Tibial Insert - e+™,3 (22mm and 25mm)3 ,6 with Reinforcement Pin Medical grade UltraHigh Molecular Weight Polyethylene (Moderately CrossLinked) CoCrMo EMPOWR VVC® Reinforcement Pin ASTM F648 / ASTM F2565 ASTM F2695 Vitamin E UHMWPE (atocopheral)

1. Size interchangeability between the EMPOWR 3D™ femur and EMPOWR Porous® Femur to EMPOWR 3D™ tibial inserts are compatible with the same size component, or one size smaller femur on a larger insert. 2. Size interchangeability between the EMPOWR PS™ femur and EMPOWR PS™ tibial inserts are compatible with the same size component, one size smaller femur on a larger insert, or one size larger femur on a smaller insert. 3. Size interchangeability between the EMPOWR PS™ femur and EMPOWR VVC® tibial inserts are compatible with the same size component, one size smaller femur on a larger insert,...

Revision Knee Insert e+™ Vitamin E UHMWPE (atocopheral) Medical grade UltraHigh Molecular Weight Polyethylene (Moderately CrossLinked) EXPRT® Revision Knee Stem Extension EXPRT® Revision Tibial Augment EXPRT® Revision Femoral Augment Medical grade UltraHigh Molecular Weight Polyethylene (Moderately CrossLinked) Vitamin E UHMWPE (atocopheral) ASTM F648 / ASTM F2565 ASTM F2695 EXPRT® Patella – All Poly e+

EMPOWR Partial KNEE™ System EMPOWR Partial KNEE™ Femur EMPOWR Partial KNEE™ Tibial Baseplate EMPOWR Partial KNEE™ Tibial Insert e+™ Medical grade UltraHigh Molecular Weight Polyethylene (Moderately CrossLinked) Vitamin E UHMWPE (atocopheral) ASTM F648 / ASTM F2565 ASTM F2695

EPIK® Uni Tibial Insert Medical grade UltraHigh Molecular Weight Polyethylene Medical grade UltraHigh Molecular Weight Polyethylene Medical grade UltraHigh Molecular Weight Polyethylene (Moderately CrossLinked) Vitamin E UHMWPE (atocopheral) Patella, Screws, Plugs Patella – All Poly, Domed & Sombrero Patella – All Poly e+™, Domed1 & Sombrero