# K103733: United U2 Xpe Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Aug 2, 2011 after 223 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 K003910 (2001). 10 ancestors in all.
8 later devices descend from it; 6 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 1.
- K021657: Uknee Total Knee System, United Orthopedic Corp. (2002) Summary page 1.
- K013991: Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface Components, Zimmer, Inc. (2001) Summary page 1.
- K071991: Modification to Scorpio NRG Knee System, Howmedica Osteonics Corp. (2007) Summary page 1.
- K072281: Nexgen Prolong All-Poly Patella, Zimmer, Inc. (2007) Summary page 1.
- K051977: Scorpio Knee System Tibial Inserts and Patellar Components, Howmedica Osteonics Corp. (2005). Our reading of the summary gave K051997, FDA’s number for Capiox RX15 Hollow, Fiber Oxygenator with/Without… (Terumo Cardiovascular Systems Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “"Howmedica Osteonics" Scorpio X3 Patellar components”.

## Most influential descendants
- K132752: Ultracongruent Insert (2014), 5 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
- 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

## Recalls of this device
- Feb 20, 2013 · Class II · Z-1379-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to
- Feb 20, 2013 · Class II · Z-1380-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to

## 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, posttraumnatic 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 system is designed for cemented use only in the U.S.A.

Source page: https://510kreport.com/device/K103733
Methodology: https://510kreport.com/methodology