PMA P830055S351

Device: Attune Revision Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S351
Product code: NJL
Decision date: 2026-09-21
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: approval for the following two changes for the Attune Revision CRS Rotating Platform (CRS RP) tibial insert components of the Attune Revision Knee System:i. change in the manufacturing consolidation process to add ram extrusion as an alternative to compression molding for bar stock material antioxidant (Pentaerythritol tetrakis [3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate]) (AOX), Ultra-High Molecular Weight Polyethylene (UHMWPE) material of the aforementioned components.ii. change in sterilization dose from a single, high dose sterilization to a split-dose sterilization method through a combination of crosslinking AOX UHMWPE raw material and final terminal sterilization of the aforementioned components.

Current openFDA PMA Record#

Device: Attune Revision Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S351
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-09-21
Decision code: APPR
Date received: 2025-09-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for the following two changes for the Attune Revision CRS Rotating Platform (CRS RP) tibial insert components of the Attune Revision Knee System:i. change in the manufacturing consolidation process to add ram extrusion as an alternative to compression molding for bar stock material antioxidant (Pentaerythritol tetrakis [3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate]) (AOX), Ultra-High Molecular Weight Polyethylene (UHMWPE) material of the aforementioned components.ii. change in sterilization dose from a single, high dose sterilization to a split-dose sterilization method through a combination of crosslinking AOX UHMWPE raw material and final terminal sterilization of the aforementioned components.