Ortho Development Corporation

CK Tibial Insert Sz 6 12mm Part 563-1612, Lot A135666

Orthopedic Devices

2

Yes

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

Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY || Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed

UC Tibial Insert Sz 3 10mm,Part 163-3310,Lot A136109,UC Tibial Insert Sz 4 8mm,Part 163-3408,Lot A135948,UC Tibial Insert Sz 4 14mm,Part 163-3414,Lot A136110,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136113,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136746,

Orthopedic Devices

2

Yes

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

Tibila Insert UC, Balanced Knee System, REF163-3YYY || Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation 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

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

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