Name: Predicase
Price: 199 USD

K-number	K222056
Device name	Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
Applicant	Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Product code	JDI
Device class	Class II
Decision date	Jan 26, 2023
Decision	Substantially Equivalent
Regulation	888.3350

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

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 →

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee

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