NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS

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Orthopedic Devices

2

Yes

Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.

NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 1, sterile, REF 00-5950-027-01, Zimmer Inc. Warsaw, IN. || This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.

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Orthopedic Devices

2

Yes

Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.

NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 2, sterile, REF 00-5950-027-02, Zimmer Inc. Warsaw, IN. || This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.

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61410283, 61410284, 61410285, 61412375 and 61412376.

Orthopedic Devices

2

Yes

Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.

NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4, sterile, REF 00-5950-037-02, Zimmer Inc. Warsaw, IN. || This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.

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Orthopedic Devices

2

Yes

Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.

NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 5, sterile, REF 00-5950-047-01, Zimmer Inc. Warsaw, IN. || This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.

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Orthopedic Devices

2

Yes

Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.

NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 6, sterile, REF 00-5950-047-02, Zimmer Inc. Warsaw, IN. || This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.