PMA P060037S080

Device: NexGen® LPS-Flex / LPS-Mobile Bearing Knee
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S080
Product code: NJL
Decision date: 2022-08-15
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Approval for revising device labeling, specifically package inserts, to implement the following changes: removal of re-sterilization information; addition of caution information for metal sensitivity and product cleanliness; addition of contact information for product compatibility questions; disclosure of residual risks with products; and addition of product disposal information.

Current openFDA PMA Record#

Device: NexGen® LPS-Flex / LPS-Mobile Bearing Knee
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S080
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-08-15
Decision code: APPR
Date received: 2022-07-25
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for revising device labeling, specifically package inserts, to implement the following changes: removal of re-sterilization information; addition of caution information for metal sensitivity and product cleanliness; addition of contact information for product compatibility questions; disclosure of residual risks with products; and addition of product disposal information.