# K243021: Longboard Revision Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Aug 7, 2025 after 314 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: 8 generations back to K850055 (1985). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151902: REDAPT¿ Revision Femoral System, Smith & Nephew, Inc. (2015) Summary page 6.
- K100469: Arcos Interlocking Distal Stems, Biomet Manufacturing Corp (2010) Summary page 6.
- K192883: Spartan Hip Stem, Signature Orthopaedics Pty, Ltd. (2020) Summary page 6.

## 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 & fracture non-union or mal-union • 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, hemiarthroplasty, surface replacement, or total hip replacement • Dislocation risks (when used with SignaSure Dual Mobility System) Signature Orthopaedics’ Longboard Revision Stem is intended for individuals undergoing revision surgery of the hip only. Signature Orthopaedics’ Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World, Everglade and Longboard Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Source page: https://510kreport.com/device/K243021
Methodology: https://510kreport.com/methodology