# K161705: U2 Total Knee System E-XPE products

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Mar 16, 2017 after 269 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K915132 (1992). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103733: United U2 Xpe Total Knee System, United Orthopedic Corporation (2011) Summary page 4.
- K131864: U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment, United Orthopedic Corporation (2014) Summary page 4.
- K132752: Ultracongruent Insert, United Orthopedic Corporation (2014) Summary page 4.
- K150829: U2 Total Knee System- Additional Sizes, United Orthopedic Corporation (2015) Summary page 4.
- K082424: United U2 Total Knee System, United Orthopedic Corp. (2008) Summary page 4.

## Cited in the summary but kept off the family tree
- K031640: U2 Total Knee System- Insert and Patella. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4.

## Most influential descendants
- K222700: Tibial baseplate, Tibial insert (2022), 0 descendants of its own

## Indications for use
For E-XPE Insert (CR, PS and UC type) and Patella: The device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function 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 erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is a single use implant and intended for cemented use only. For E-XPE Insert (PSA type) This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function 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 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 constrained stabilization for tibiofemoral joint due to soft tissue imbalance. This device is a single use implant and intended for cemented use only.

Source page: https://510kreport.com/device/K161705
Methodology: https://510kreport.com/methodology