# K192024: Cemented TSI Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Jun 19, 2020 after 326 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K930712 (1993). 106 ancestors in all.
No later device cites it as a predicate yet.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181340: Cemented TSI Hip Stem, Signature Orthopaedics Pty, Ltd. (2019) Summary page 4.
- K133370: Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve CE, Signature Orthopaedics Pty Limited (2014) Summary page 4.

## Indications for use
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: • Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis • Inflammatory joint disease including rheumatoid arthritis • Correction of functional deformity including congenital hip dysplasia • Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture • Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement Signature Orthopaedics’ Origin, Aria, Remedy, TSI and Pegasus femoral stems and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics’ Evolve, Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems are intended for cemented fixation only. Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. Signature Orthopaedics’ Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as: • Acute femoral head or neck fracture • Fracture dislocation of the hip • Avascular necrosis of the femoral head • Non-union of femoral neck fractures • Certain high subcapital and femoral neck fractures in the elderly • Degenerative arthritis involving only the femoral head

Source page: https://510kreport.com/device/K192024
Methodology: https://510kreport.com/methodology