# K131864: U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Jan 15, 2014 after 205 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: 5 generations back to K915132 (1992). 21 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051640: U2 Total Knee System, United Orthopedic Corp. (2006)
- K103733: United U2 Xpe Total Knee System, United Orthopedic Corporation (2011) Summary page 1.
- K082424: United U2 Total Knee System, United Orthopedic Corp. (2008) Summary page 1.
- K122183: Augment and Screw, Psa Type, United Orthopedic Corp. (2013) Summary page 1.
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO, Zimmer, Inc. (1999) Summary page 1.

## Most influential descendants
- K150829: U2 Total Knee System- Additional Sizes (2015), 3 descendants of its own
- K161705: U2 Total Knee System E-XPE products (2017), 1 descendant of its own
- K222700: Tibial baseplate, Tibial insert (2022), 0 descendants of its own
- K210961: U2 Total Knee System, XPE Tibial Insert, PS PLUS (2021), 0 descendants of its own
- K152430: All Poly Tibial Component (2016), 0 descendants of its own

## Indications for use
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 may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device system is designed for cemented use only.

Source page: https://510kreport.com/device/K131864
Methodology: https://510kreport.com/methodology