PMA P960054S002

Device: S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER
Applicant: Depuy, A Johnson & Johnson Co.
PMA number: P960054
Supplement: S002
Product code: KWZ
Decision date: 1999-12-07
Generic name: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Approval order statement: Approval for a design modification made to the S-ROM constrained liner so to be used withthe DePuy Duraloc and Solution Acetabular Cup Systems. This device is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Current openFDA PMA Record#

Device: S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER
Applicant: Depuy, A Johnson & Johnson Co.
PMA number: P960054
Supplement: S002
Product code: KWZ
Generic name: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Decision date: 1999-12-07
Decision code: APPR
Date received: 1999-07-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a design modification made to the S-ROM constrained liner so to be used withthe DePuy Duraloc and Solution Acetabular Cup Systems. This device is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.