# K221705: U2 Total Knee System-PF+

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Feb 28, 2023 after 260 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K951987 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140075: U2 Femoral Component, CR, Porous Coated, United Orthopedic Corp. (2014) Summary page 4.
- K150832: U2 Femoral Component, CR, Porous Coated, Additional Sizes, United Orthopedic Corporation (2015) Summary page 4.

## Most influential descendants
- K243656: U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (2025), 0 descendants of its own

## Indications for use
U2 Total Knee System - PF+ 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 deformities. 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. Femoral Component, PF+, Tibial Baseplate, PF+ and Tibial Extension Stem are indicated for both cemented and cementless use.

Source page: https://510kreport.com/device/K221705
Methodology: https://510kreport.com/methodology