# K133370: Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve CE

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty Limited
- Decided: Jul 22, 2014 after 260 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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 K930712 (1993). 104 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 2.
- K010367: Modification to Titanium Tri-Lock Hips Stem, DePuy Orthopaedics, Inc. (2001) Summary page 1.
- K072852: SL-Plus Standard and Lateral Hip Stems, Smith & Nephew, Inc. (2008) Summary page 3.
- K040803: MS-30 Femoral Stem Standard and Lateral, Zimmer, Inc. (2004) Summary page 1.
- K974054: Distal Centralizer, Exeter II Hip System, Howmedica, Inc. (1997) Summary page 2.
- K791125: Plug-Lok Cement Restirctor, Richard'S Medical Equip., Inc. (1979) Summary page 2.
- K812672: Self-Centering Hip, Depuy, Inc. (1981) Summary page 2.
- K091967: Medacta Bipolar Head, Medacta International S.A. (2010) Summary page 2.
- K962101: Zweymueller SL Femoral Hip Stem, Intermedics Orthopedics (1996) Summary page 3.
- K980843: Exeter Intramedullary Bone Plug, Howmedica, Inc. (1998) Summary page 3.

## Cited in the summary but kept off the family tree
- K010290: Howmedica Exeter Hip Stem. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K143184: Evolve UniPolar Head (2015), 1 descendant of its own
- K243043: Origin™ Cemented Hip Stem (2025), 0 descendants of its own
- K201047: Fusion Taper System (2021), 0 descendants of its own
- K191708: Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head (2020), 0 descendants of its own
- K192024: Cemented TSI Hip Stem (2020), 0 descendants of its own

## 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, NEO-T, Remedy and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve femoral stems are intended for cemented fixation only. Signature Orthopaedics' Bipolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The BiPolar Head is 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/K133370
Methodology: https://510kreport.com/methodology