# K222700: Tibial baseplate, Tibial insert

- Pathway: 510(k) (Special)
- Applicant: United Orthopedic Corporation
- Decided: Oct 6, 2022 after 29 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: 8 generations back to K915132 (1992). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131864: U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment, United Orthopedic Corporation (2014) Summary page 4.
- K051640: U2 Total Knee System, United Orthopedic Corp. (2006) Summary page 4.
- K150829: U2 Total Knee System- Additional Sizes, United Orthopedic Corporation (2015) Summary page 4.
- K103733: United U2 Xpe Total Knee System, United Orthopedic Corporation (2011) Summary page 4.
- K132752: Ultracongruent Insert, United Orthopedic Corporation (2014) Summary page 5.
- K161705: U2 Total Knee System E-XPE products, United Orthopedic Corporation (2017) Summary page 5.

## Indications for use
For Tibial baseplate, CMA, #0 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 joint surface 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. For Tibial insert, #0 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.

Source page: https://510kreport.com/device/K222700
Methodology: https://510kreport.com/methodology