# Signature Orthopaedics PTY Limited (manufacturer, Sydney New South Wales, AU): 12 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Signature Orthopaedics PTY Limited |
| Owner / operator | Signature Orthopaedics Pty Limited |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | Sydney New South Wales, AU |
| New listings | 12 |
| Devices | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; 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 Uncemented Acetabular Component); Prosthesis, Hip, Femoral, Resurfacing |
| Product codes | LPH, KWY, LZO, KWZ, JDI, MEH, KWA, KXA |
| Device classes | Class II, Class III |
| Medical specialties | Orthopedic |
| Brand names | Evolve AP Cup |
| First new listing | 2026-06-01 |
| Latest new listing | 2026-07-07 |
| FDA registration number | 3008262872 |
| 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.