# Materialise Colombia S.A.S (manufacturer, Medellin Antioquia, CO): 3 new FDA device listings, incl. shoulder arthroplasty implantation system

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Materialise Colombia S.A.S |
| Owner / operator | Materialise N.V. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Medellin Antioquia, CO |
| New listings | 3 |
| Devices | Shoulder Arthroplasty Implantation System; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Product codes | QHE, PHX, KWS |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | Materialise Shoulder Planner; Lima Personalized Surgical Instruments; Materialise Glenoid Positioning System; AtlasPlan Shoulder System; Materialise Shoulder System; Materialise Glenoid Positioning System guides; SurgiCase Shoulder Planner; SurgiCase Planner |
| First new listing | 2026-07-08 |
| Latest new listing | 2026-07-08 |
| FDA registration number | 3011724582 |
| 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.