# K082424: United U2 Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corp.
- Decided: Dec 16, 2008 after 116 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K021657 (2002). 3 ancestors in all.
15 later devices descend from it; 9 cite it directly.
0 of 19 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) Summary page 4.
- K960279: Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces, Zimmer, Inc. (1996) Summary page 1.

## Most influential descendants
- K122183: Augment and Screw, Psa Type (2013), 10 descendants of its own
- K131864: U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment (2014), 5 descendants of its own
- K150829: U2 Total Knee System- Additional Sizes (2015), 3 descendants of its own
- K100981: United Stem, Psa Type (2010), 3 descendants of its own
- K190100: USTAR II System (2019), 2 descendants of its own

## Recalls of this device
- May 20, 2026 · Class II · Z-2883-2026: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- Nov 24, 2017 · Class II · Z-1129-2018: UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.

## 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 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

Source page: https://510kreport.com/device/K082424
Methodology: https://510kreport.com/methodology