Name: Predicase
Price: 199 USD

K-number	K253197
Device name	ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
Applicant	Depuy Ireland UC
Product code	JWH
Device class	Class II
Decision date	Nov 19, 2025
Decision	Substantially Equivalent
Regulation	888.3560

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

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ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors

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

ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors