# K152430: All Poly Tibial Component

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Apr 12, 2016 after 230 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: 6 generations back to K915132 (1992). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974556: Osteonics Scorpio Posterior Cruciate Retaining Total Knee System, Osteonics Corp. (1998) Summary page 4.
- K962152: Osteonics Scorpio Posteriorly Stabilized Total Knee System, Osteonics Corp. (1996) Summary page 4.
- K051640: U2 Total Knee System, United Orthopedic Corp. (2006) 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.

## Indications for use
The device is indicated for use in total knee arthroplasty in skeletally mature patients with the following conditions: 1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. 2. Collagen disorders, and/or avascular necrosis of the femoral condyle. 3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. 4. Moderate valgus, varus, or flexion deformities. 5. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. The device includes Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracongruent (UC) type. CR and UC types are designed to collocate with CR femoral component, while PS type is designed to collocate with PS femoral component. This device is a single use implant and intended for cemented use only.

Source page: https://510kreport.com/device/K152430
Methodology: https://510kreport.com/methodology