Chrysalis Intelligence · Sponsors · Shoulder Innovations, Inc.

Shoulder Innovations, Inc.

Grand Rapids, MI, US · 7 510(k) clearances

Total clearances
7
2021-08-20 → 2026-09-08
Last 12 months
3
Product codes
3
Most recent
2026-09-08
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PHX Shoulder Prosthesis, Reverse Configuration Class II Orthopedic 4 2026-04-13
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Class II Orthopedic 2 2026-09-08
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Class II Orthopedic 1 2022-03-11
Filings

All 510(k) clearances (7)

Date K-number Device Code Class Specialty
2026-09-08 K262173 N22 Offset Humeral Head KWT Class II Orthopedic
2026-04-13 K254128 InSet Reverse Total Shoulder System PHX Class II Orthopedic
2026-01-15 K252516 N22 EZ Glenosphere PHX Class II Orthopedic
2025-09-26 K252221 Inset Reverse Total Shoulder System PHX Class II Orthopedic
2025-02-11 K241817 InSet Total Shoulder System KWT Class II Orthopedic
2022-03-11 K213615 Shoulder Innovations Total Shoulder System PKC Class II Orthopedic
2021-08-20 K210533 Inset Reverse Total Shoulder System PHX Class II Orthopedic