PMA P150030S049

Device: R3™ Delta Ceramic Acetabular System
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S049
Product code: MRA
Decision date: 2025-04-17
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: a change to the final cleaning monitoring process to reduce the frequency of product endotoxin testing from bi-weekly to quarterly for the R3 Shells at Smith & Nephew Operations Malaysia (SNOM)

Current openFDA PMA Record#

Device: R3™ Delta Ceramic Acetabular System
Applicant: Smith & Nephew, Inc.
PMA number: P150030
Supplement: S049
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2025-04-17
Decision code: OK30
Date received: 2025-03-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to the final cleaning monitoring process to reduce the frequency of product endotoxin testing from bi-weekly to quarterly for the R3 Shells at Smith & Nephew Operations Malaysia (SNOM)