PMA P010014S118

Device: Oxford Partial Knee Anatomic Vivacit-E Meniscal Bearings
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S118
Product code: NRA
Decision date: 2026-09-01
Classification: Orthopedic
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: an additional supplier of tantalum balls used during manufacturing of Oxford Partial Knee Anatomic Vivacit-E Meniscal Bearings at the Zimmer Inc., Warsaw, Indiana facility

Current openFDA PMA Record#

Device: Oxford Partial Knee Anatomic Vivacit-E Meniscal Bearings
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S118
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-09-01
Decision code: OK30
Date received: 2026-08-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an additional supplier of tantalum balls used during manufacturing of Oxford Partial Knee Anatomic Vivacit-E Meniscal Bearings at the Zimmer Inc., Warsaw, Indiana facility