FDA applicant
Shoulder Innovations, Inc.
FDA records 12 decisions for Shoulder Innovations, Inc. (Grand Rapids, MI) from 2011 to 2026: 12 510(k) clearances. Most are in product codes PHX (Shoulder Prosthesis, Reverse Configuration) and KWS (Prosthesis, Shoulder, Semi-Constrained…). Since 2016 its 510(k)s took a median of 116 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 9 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Shoulder Innovations, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shoulder Innovations, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Shoulder Innovations, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Shoulder”
FDA records each applicant name separately; these may or may not be the same firm.