Ortho Development Corporation

Lot No. A131876

Orthopedic Devices

2

Yes

US Nationwide Distribution in the states of NV, and AZ.

PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.

Lot numbers 1365304, 1365305.

Orthopedic Devices

2

Yes

Nationwide Distribution-including the states of AZ, CA, FL, MI, OR, TX, and UT.

U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep Kit and Part Number 228-9001-Triplus Acetabular Instrument Kit. || The Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented, biological fixation. The Hex Head Drive is used to place the screw that affixes the acetabular cup to the hip acetabulum.

Pivot Bipolar Cup 22x42mm,Part 133-2242,Lot A136254,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136256,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136255,Pivot Bipolar Cup 22x44mm,Part 133-2244,Lot A136257,Pivot Bipolar Cup 22x45mm,Part 133-2245,Lot A136258,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136259,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136260,Pivot Bipolar Cup 22x47mm,Part 133-2247,Lot A136261,Pivot Bipolar Cup 22x48mm,Part 133-2248,Lot A136262,Pivot Bipolar Cup 22x49mm,Part 133-2249,Lot A136263,Pivot Bipolar Cup 22x50mm,Part 133-2250,Lot A136265,Pivot Bipolar Cup 22x51mm,Part 133-2251,Lot A136266,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136269,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136268,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136267,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136270,

Orthopedic Devices

2

Yes

Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.

Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY || Product Usage: || Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum

Patella 38mm Part 164-0038, Lot A135844

Orthopedic Devices

2

Yes

Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.

Patella 38mm, REF164-0038 || Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component

PS Tibial Insert Size 3 8mm,Part 163-1308,Lot A135943,PS Tibial Insert Size 3 9mm,Part 163-1309,Lot A136492,PS Tibial Insert Size 3 12mm,Part 163-1312,Lot A136453,PS Tibial Insert Size 4 7mm,Part 163-1407,Lot A135945,PS Tibial Insert Size 4 7mm,Part 163-1407,Lot A136454,PS Tibial Insert Size 5 9mm,Part 163-1509,Lot A135827,

Orthopedic Devices

2

Yes

Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.

PS Tibial Insert, REF 163-1XXX || Product Usage: || UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component