PMA P070026S129

Device
CERAMAX CERAMIC HIP SYSTEM
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S129
Product code
MRA
Decision date
2026-09-04
Classification
Orthopedic
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
the addition of an alternate component forging supplier for business continuity purposes.

Current openFDA PMA Record#

Device
CERAMAX CERAMIC HIP SYSTEM
Applicant
DePuy Orthopaedics, Inc.
PMA number
P070026
Supplement
S129
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2026-09-04
Decision code
OK30
Date received
2026-08-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
the addition of an alternate component forging supplier for business continuity purposes.