Name: Predicase
Price: 199 USD

K-number	K252221
Device name	Inset Reverse Total Shoulder System
Applicant	Shoulder Innovations, Inc.
Product code	PHX
Device class	Class II
Decision date	Sep 26, 2025
Decision	Substantially Equivalent
Regulation	888.3660

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Inset Reverse Total Shoulder System

Everything you need for a 510(k) submission. Nothing you don't.