# Precision Ai PTY Ltd (contract manufacturer, Brisbane Queensland, AU): 9 new FDA device listings, incl. shoulder arthroplasty implantation system

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Precision Ai PTY Ltd |
| Owner / operator | Kico Knee Innovation Company |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Brisbane Queensland, AU |
| New listings | 9 |
| Devices | Shoulder Arthroplasty Implantation System; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Shoulder Prosthesis, Reverse Configuration |
| Product codes | QHE, KWS, PHX |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | ASTRA Portal Surgical Planning System |
| First new listing | 2026-10-21 |
| Latest new listing | 2026-10-21 |
| FDA registration number | 3031914485 |
| Registration expires | 2027-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.

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.