PMA P090002S002

Device: DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
PMA number: P090002
Supplement: S002
Product code: OVO
Decision date: 2012-04-17
Generic name: Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
Approval order statement: APPROVAL FOR THE ADDITION OF THE TRILOCK BPS (BONE PRESERVING HIP STEM) TO THE LIST OF COMPATIBLE FEMORAL STEM COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM AND IS INDICATED AS A SINGLE USE DEVICE INTENDED FOR UNCEMENTED FIXATION. THE DEVICE IS INTENDED AS A PRIMARY JOINT REPLACEMENT PROSTHESIS IN TOTAL HIP ARTHROPLASTY FOR SKELETALLY MATURE PATIENTS SUFFERING AT LEAST MODERATE PAIN IN THE HIP JOINT FROM NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) AND ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS (OA) OR POST-TRAUMATIC ARTHRITIS. THE DEVICE¿S INSERTS (PINNACLE ULTAMET) ARE ONLY INTENDED FOR USE WITH DEPUY¿S FEMORAL AND ACETABULAR COMPONENTS HAVING MATCHING OUTER AND INNER DIAMETERS.

Current openFDA PMA Record#

Device: DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM
Applicant: DePuy Orthopaedics, Inc.
PMA number: P090002
Supplement: S002
Product code: OVO
Generic name: Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
Decision date: 2012-04-17
Decision code: APPR
Date received: 2012-01-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF THE TRILOCK BPS (BONE PRESERVING HIP STEM) TO THE LIST OF COMPATIBLE FEMORAL STEM COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM AND IS INDICATED AS A SINGLE USE DEVICE INTENDED FOR UNCEMENTED FIXATION. THE DEVICE IS INTENDED AS A PRIMARY JOINT REPLACEMENT PROSTHESIS IN TOTAL HIP ARTHROPLASTY FOR SKELETALLY MATURE PATIENTS SUFFERING AT LEAST MODERATE PAIN IN THE HIP JOINT FROM NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) AND ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS (OA) OR POST-TRAUMATIC ARTHRITIS. THE DEVICE¿S INSERTS (PINNACLE ULTAMET) ARE ONLY INTENDED FOR USE WITH DEPUY¿S FEMORAL AND ACETABULAR COMPONENTS HAVING MATCHING OUTER AND INNER DIAMETERS.