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This device is indicated in knee arthroplasty in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.

Note: In the US, this device is for cemented use only.

"UNITED" U2 Total Knee System – Posterior Stabilized Augmentable (PSA) type is a patellofemorotibial polymer/ metal/ polymer, semiconstrained, cemented knee prosthesis, which has a metallic femoral component and a tibial component composed of a polyethylene insert and a metallic tibial baseplate. Tibial inserts are available in two design configurations: for the PSA type insert, it is intended for use in patients who require constrained stabilization of the tibiofemoral joint due to soft tissue imbalance. While the PSA low constrained type (PSA, LC) insert provides less constrained stabilization than the PSA type insert.

This system is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock. There are a variety of components including femoral augment set, tibial augment, stem extension and offset stem adapter that provide more choices for surgeon to treat their patients. In addition, this system provides more stability for patients with inadequate medial-lateral, anterior-posterior or varus-valgus soft tissue imbalance. For total knee replacement, "UNITED" patella components are intended to be used with the U2 Total Knee System—PSA Type.

For the subject device, it's a line extension of the 510(K) cleared device U2 Total Knee System—PSA Type (K082424), which introduces the variation, Straight Stem, Cross Slot, PSA, with stem lengths from 75mm to 200mm, diameters from Ø10 to Ø24mm.

The compatibility of the Straight Stem, Cross Slot, PSA is the same as that of the 510(k) cleared U2 Total Knee System—PSA Type (K082424).

The Straight Stem, Cross Slot, PSA is an extension of the geometric characteristics of the 510(k) cleared device, U2 Total Knee System—PSAType (K082424). Its materials, size, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Straight Stem, PSA.

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