SHOULDER INNOVATIONS, Inc (specification developer, Grand Rapids, MI): 7 new FDA device listings, incl. prosthesis, shoulder, non-constrained, metal/polymer cemented
SHOULDER INNOVATIONS, Inc (Grand Rapids, Michigan): 7 new FDA device listings, incl. prosthesis, shoulder, non-constrained, metal/polymer cemented. Its amount of 7 is top-decile (90th percentile of 2,570 records). Dated 20 days ago, it is in the active follow-up window. Score 95/100. 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: 7 · 90th percentile of 2,570 DeviceEstablishmentPulse records · 7.0x 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 | SHOULDER INNOVATIONS, Inc |
| Owner / operator | Shoulder Innovations, Inc |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Grand Rapids, MI, US |
| New listings | 7 |
| Devices | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Shoulder Prosthesis, Reverse Configuration |
| Product codes | KWT, HSD, KWS, MBF, PHX |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | N22 Offset Humeral Head; InSet Reverse Total Shoulder System; N22 EZ Glenosphere |
| First new listing | 2026-10-15 |
| Latest new listing | 2026-10-15 |
| FDA registration number | 3012544635 |
| Registration expires | 2027-12-31 |
| amount percentile | 90th of 2,570 (median 1, 7.0x 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: 2026-10-15
- 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: SHOULDER INNOVATIONS, Inc and 25 Michigan peers
- Michigan DeviceEstablishmentPulse records like this one: 25
- SHOULDER INNOVATIONS, Inc's amount: 90th percentile of 2,570 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Michigan peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
95 / 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.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for SHOULDER INNOVATIONS, Inc in Grand Rapids, Michigan?
SHOULDER INNOVATIONS, Inc (Grand Rapids, MI), a specification developer (outsources manufacturing), added 7 FDA device listings on 2026-10-15.
How does SHOULDER INNOVATIONS, Inc compare to other Michigan DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 7 is 7.0x the median of 1 across 2,570 records. It is 20 days old, still within a typical 45-day follow-up window. Its Score of 95/100 puts it among the stronger signals in this feed.
SHOULDER INNOVATIONS, Inc vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| SHOULDER INNOVATIONS, Inc | Grand Rapids, MI | 7 | 90th | 2026-10-15 |
| Sol-Millennium Medical, Inc. | Chicago, IL | 8 | 91st | 2026-09-28 |
| Boston Scientific Corporation | Marlborough, MA | 9 | 92nd | 2026-10-16 |
| Orthopediatrics, Corp | Warsaw, IN | 5 | 87th | 2026-09-28 |
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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Michigan
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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.