# Signature Orthopaedics Europe Ltd (manufacturer, Athlone Westmeath, IE): 4 new FDA device listings, incl. prosthesis, hip, constrained, cemented or uncemented, metal/polymer

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Signature Orthopaedics Europe Ltd |
| Owner / operator | Signature Orthopaedics Pty Limited |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Athlone Westmeath, IE |
| New listings | 4 |
| Devices | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Product codes | KWZ, JDI, MEH, LPH |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | Evolve AP Cup |
| First new listing | 2026-06-01 |
| Latest new listing | 2026-06-01 |
| FDA registration number | 3014763043 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.