DeviceEstablishmentPulse / report
Materialise USA, LLC. (manufacturer, Plymouth, MI): 3 new FDA device listings, incl. shoulder arthroplasty implantation system
Materialise USA, LLC. (Plymouth, Michigan): 3 new FDA device listings, incl. shoulder arthroplasty implantation system. Its amount of 3 is above the median of 1 (77th percentile). Dated 119 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 3 · 77th percentile of 2,570 DeviceEstablishmentPulse records · 3.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 24 related MI DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Materialise USA, LLC. |
| Owner / operator | Materialise N.V. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Plymouth, MI, US |
| 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 | Lima Personalized Surgical Instruments; Materialise Shoulder Guide and Models; Materialise Shoulder System; TruMatch Personalized Solutions Shoulder Guide; SurgiCase Shoulder Planner; AtlasPlan Shoulder System; Materialise Shoulder Planner; Materialise Glenoid Positioning System guides |
| First new listing | 2026-07-08 |
| Latest new listing | 2026-07-08 |
| FDA registration number | 3005718816 |
| Registration expires | 2026-12-31 |
| amount percentile | 77th of 2,570 (median 1, 3.0x median) |
| Peer records CSV (25 MI records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-07-08
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Materialise USA, LLC. and 25 Michigan peers
- Michigan DeviceEstablishmentPulse records like this one: 25
- Materialise USA, LLC.'s amount: 77th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Michigan peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 100 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.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Materialise USA, LLC. in Plymouth, Michigan?
Materialise USA, LLC. (Plymouth, MI), a manufacturer, added 3 FDA device listings on 2026-07-08.
How does Materialise USA, LLC. compare to other Michigan DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,570 records; the median is 1. It is 119 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.
Materialise USA, LLC. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Materialise USA, LLC. | Plymouth, MI | 3 | 77th | 2026-07-08 |
| Beacon Biosignals, Inc. | Boston, MA | 3 | 77th | 2026-10-16 |
| Endovascular Engineering, Inc. | Menlo Park, CA | 3 | 77th | 2026-10-14 |
| INNO Holdings Inc. | Millcreek, UT | 3 | 77th | 2026-10-05 |
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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.