# K243656: U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Jul 31, 2025 after 247 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: 8 generations back to K921308 (1994). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212941: Porous Patella, Encore Medical, L.P. Dba Djo Surgical (2022) Summary page 6.
- K132624: Triathlon Tritanium Metal-Backed Patella, Stryker Orthopaedics (2013) Summary page 6.
- K221705: U2 Total Knee System-PF+, United Orthopedic Corporation (2023) Summary page 6.
- K190100: USTAR II System, United Orthopedic Corporation (2019) Summary page 7.

## 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+, Tibial Extension Stem, Patella, Onset, E-XPE, PF+, and Patella, Asymmetric Onset, E-XPE, PF+ are indicated for both cemented and cementless use. USTAR II Total Knee System 1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed. 2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed. 3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis. 4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis. 5. Joint instability resulting from excessive bone resection. For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only. For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and intended for cementless use only.

Source page: https://510kreport.com/device/K243656
Methodology: https://510kreport.com/methodology