K-number	K091453
Device name	LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
Applicant	DePuy Orthopaedics, Inc.
Product code	KRO
Device class	Class II
Decision date	Aug 12, 2009
Decision	Substantially Equivalent
Regulation	888.3510

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331

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