# K190100: USTAR II System

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Sep 23, 2019 after 244 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921308 (1994). 53 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082424: United U2 Total Knee System, United Orthopedic Corp. (2008) Summary page 5.
- K100981: United Stem, Psa Type, United Orthopedic Corp. (2010) Summary page 5.
- K122183: Augment and Screw, Psa Type, United Orthopedic Corp. (2013) Summary page 5.
- K013385: Nexgen Complete Knee Solution Rotatng Hinge Knee, Zimmer, Inc. (2002) Summary page 5.
- K070978: Zimmer Segmental System, Zimmer, Inc. (2007) Summary page 5.
- K110940: Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen, Zimmer, Inc. (2011) Summary page 5.
- K002757: Oncology Salvage System, Biomet, Inc. (2000) Summary page 6.
- K052685: Orthopedic Salvage System- Oss, Biomet, Inc. (2005) Summary page 6.
- K130063: Arcos Trochanter Button, Biomet, Inc. (2013) Summary page 6.

## Most influential descendants
- K252303: Stem Extension Line (USTAR II System) (2025), 0 descendants of its own
- K243656: U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (2025), 0 descendants of its own

## Recalls of this device
- May 20, 2026 · Class II · Z-2884-2026: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- Jan 3, 2024 · Class II · Z-1216-2024: Their is a potential that the implant curved stem may be oriented incorrectly.
- Jan 3, 2024 · Class II · Z-1217-2024: Their is a potential that the implant curved stem may be oriented incorrectly.
- Jan 3, 2024 · Class II · Z-1215-2024: Their is a potential that the implant curved stem may be oriented incorrectly.
- Aug 27, 2021 · Class II · Z-0110-2022: Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.

## Indications for use
USTAR II 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. USTAR II Knee System, Stem 1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) resulting from trauma 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. Correction for revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement. 5. Joint instability resulting from excessive bone resection. Cemented Tibial Stem is a single use implant and intended for cemented use only. Tibial Stem is a single use implant and intended for cementless use only. USTAR II Hip 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. This device is a single use implant and intended for cementless use only.

Source page: https://510kreport.com/device/K190100
Methodology: https://510kreport.com/methodology