# K231109: Xerxes Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Xerxes Arthopedix, LLC
- Decided: Jun 15, 2023 after 57 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). 128 ancestors in all.
No later device cites it as a predicate yet.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170845: MiniMAX, Medacta International S.A. (2017) Summary page 4.
- K192352: MiniMAX, Medacta International S.A. (2019) Summary page 4.
- K192883: Spartan Hip Stem, Signature Orthopaedics Pty, Ltd. (2020) Summary page 4.
- K211505: Encore Hip Stem, Signature Orthopaedics Pty, Ltd. (2021) Summary page 4.
- K121297: Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular, Signature Orthopaedics Pty, Ltd. (2012) Summary page 4.
- K153131: Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner, Signature Orthopaedics Pty, Ltd. (2016) Summary page 4.

## Indications for use
Xerxes Hip Stems, when used with cleared and compatible Signature Orthopaedics hip replacement components, 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. Xerxes Hip femoral stems are intended for cementless fixation only. The Xerxes Hip System is intended for use with Logical, World Acetabular System and Signature Orthopaedics' Femoral Heads. Xerxes Hip when used with constrained liner components is indicated particularly for patients at high risk of hip dislocation due to history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Source page: https://510kreport.com/device/K231109
Methodology: https://510kreport.com/methodology