PMA P010014S101

Device: Oxford Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S101
Product code: NRA
Decision date: 2022-04-04
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: The following PET/AlOx/LLDPE packaging pouch related changes: 1) new 2nd tier supplier for the layer lamination process; 2) alternate adhesive material used in lamination process; 3) relocation of PET/AlOx production; and 4) alternate supplier of LLDPE sealant layer material.

Current openFDA PMA Record#

Device: Oxford Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S101
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-04-04
Decision code: OK30
Date received: 2022-03-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The following PET/AlOx/LLDPE packaging pouch related changes: 1) new 2nd tier supplier for the layer lamination process; 2) alternate adhesive material used in lamination process; 3) relocation of PET/AlOx production; and 4) alternate supplier of LLDPE sealant layer material.