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MDRWeb Medical Device Register On-line from Canon Communications, LLC.

Premarket Approval (PMA) Database

Premarket Approval (PMA) Database
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number:
Date Received: 07-19-2004
Decision Date: 05-09-2006
Advisory Committee: OR
Supplement Type:
Product Code: NXT (Search Manufacturers)
Supplement Reason:
Approval Order Statement:
APPROVAL FOR THE BIRMINGHAM HIP RESURFACING (BHR) SYSTEM. THE BHR SYSTEM IS A SINGLE USE DEVICE INTENDED FOR HYBRID FIXATION: CEMENTED FEMORAL HEAD COMPONENT AND CEMENTLESS ACETABULAR COMPONENT. THE HGR SYSTEM IS INTENDED FOR USE IN PATIENTS REQUIRING PRIMARY HIP RESURFACING ARTHROPLASTY DUE TO: 1) NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE JOINT DISEASE) SUCH AS OSTEOARTHRITIS, TRAUMATIC ARTHRITIS, AVASCULAR NECROSIS, OR DYSPLASIA/ DEVELOPMENTAL DISLOCATION OF THE HIP (DDH), OR 2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS. THE BHR SYSTEM IS INTENDED FOR PATIENTS WHO, DUE TO THEIR RELATIVELY YOUNGER AGE OR INCREASED ACTIVITY LEVEL, MAY NOT BE SUITABLE FOR TRADITIONAL TOTAL HIP ARTHROPLASTY DUE TO AN INCREASED POSSIBILITY OF REQUIRING FUTURE IPSILATERAL HIP JOINT REVISION.
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S001
Date Received: 08-23-2006
Decision Date: 10-13-2006
Advisory Committee: OR
Supplement Type: REAL-TIME PROCESS
Product Code: NXT (Search Manufacturers)
Supplement Reason: DESIGN CHANGE – MINOR
Approval Order Statement:
APPROVAL FOR: 1) ADDITION OF INTERMEDIATE SIZED FEMORAL HEAD COMPONENTS TO THE BHR SYSTEM (40MM, 44MM, 48MM, 52MM AND 56MM); 2) ADDITION OF ACETABULAR CUPS THAT MATE WITH THE INTERMEDIATE SIZED FEMORAL HEAD COMPONENTS (STANDARD, DYSPLASIA AND BRIDGING); AND 3) REVISIONS TO THE BHR LABELING TO REFLECT THE ADDITIONAL INTERMEDIATE SIZED COMPONENTS.
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S002
Date Received: 11-20-2006
Decision Date: 02-23-2007
Advisory Committee: OR
Supplement Type: NORMAL 180 DAY TRACK NO USER FEE
Product Code: NXT (Search Manufacturers)
Supplement Reason: LOCATION CHANGE: MANUFACTURER
Approval Order Statement:
APPROVAL FOR A MANUFACTURING SITE LOCATED AT SMITH & NEPHEW ORTHOPAEDIC LTD. IN WARWICKSHIRE, UNITED KINGDOM, FOR PURCHASING, RECEIVING ACCEPTANCE ACTIVITIES, STORAGE AND RELEASE AND DISPATCH OF PRODUCT.
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S003
Date Received: 12-26-2006
Decision Date: 10-14-2008
Advisory Committee: OR
Supplement Type: NORMAL 180 DAY TRACK NO USER FEE
Product Code: NXT (Search Manufacturers)
Supplement Reason: LOCATION CHANGE: MANUFACTURER
Approval Order Statement:
APPROVAL FOR A MANUFACTURING SITE LOCATED AT SMITH & NEPHEW ORTHOPAEDICS LTD., WARWICKSHIRE, UNITED KINGDOM, TO PERFORM FINAL MACHINING, AND A MANUFACTURING SITE LOCATED AT LPE MEDICAL LTD., HAMPSHIRE, UNITED KINGDOM.
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S004
Date Received: 03-12-2007
Decision Date: 10-01-2007
Advisory Committee: OR
Supplement Type: NORMAL 180 DAY TRACK NO USER FEE
Product Code: NXT (Search Manufacturers)
Supplement Reason: POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL
Approval Order Statement:
APPROVAL OF THE POST-APPROVAL STUDY.
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S005
Date Received: 04-02-2007
Decision Date: 06-27-2007
Advisory Committee: OR
Supplement Type: REAL-TIME PROCESS
Product Code: NXT (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS – COMPONENT
Approval Order Statement:
APPROVAL FOR THE ADDITION AND MODIFICATION OF SURGICAL INSTRUMENTS FOR USE WITH THE BHR SYSTEM AND REVISIONS TO THE SURGICAL TECHNIQUE.
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S006
Date Received: 04-16-2007
Decision Date: 11-13-2008
Advisory Committee: OR
Supplement Type: NORMAL 180 DAY TRACK
Product Code: NXT (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS – COMPONENT
Approval Order Statement:
APPROVAL FOR A LINE EXTENSION TO THE BHR SYSTEM (IE., MODULAR VERSION OF THE BHR CUP FOR USES WITH OPTIONAL SCREWS AND APEX/SCREW HOLD COVERS) AND A SITE CHANGE (SMITH & NEPHEW, INC., MEMPHIS, TENNESSEE).
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S007
Date Received: 10-17-2007
Decision Date: 06-20-2008
Advisory Committee: OR
Supplement Type: 135 REVIEW TRACK FOR 30-DAY NOTICE
Product Code: NXT (Search Manufacturers)
Supplement Reason: PROCESS CHANGE: MANUFACTURING
Approval Order Statement:
APPROVAL FOR AUTOMATION OF TWO MANUFACTURING PROCESSES UTILIZING CNC MACHINING.
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S008
Date Received: 11-17-2008
Decision Date: 01-12-2009
Advisory Committee: OR
Supplement Type: REAL-TIME PROCESS
Product Code: NXT (Search Manufacturers)
Supplement Reason: LABELING CHANGE – INSTRUCTIONS
Approval Order Statement:
APPROVAL FOR THE ADDITION OF SURGICAL INSTRUMENTS FOR USE WITH THE BHR SYSTEM AND REVISIONS TO THE SURGICAL TECHNIQUE.
Trade Name: BIRMINGHAM HIP RESURFACING SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S009
Date Received: 11-28-2008
Decision Date: 12-18-2008
Advisory Committee: OR
Supplement Type: 30-DAY NOTICE
Product Code: NXT (Search Manufacturers)
Supplement Reason: PROCESS CHANGE: MANUFACTURING
Approval Order Statement:
CHANGE IN LOCATION OF THE DISTRIBUTION AND STORAGE FACILITIES TO A FACILITY IN MEMPHIS, TENNESSEE.
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S010
Date Received: 12-17-2008
Decision Date: 02-13-2009
Advisory Committee: OR
Supplement Type: REAL-TIME PROCESS
Product Code: NXT (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS – COMPONENT
Approval Order Statement:
APPROVAL FOR THE ADDITION OF SURGICAL INSTRUMENTS FOR USE WITH THE BHR SYSTEM AND REVISIONS TO THE SURGICAL TECHNIQUE.
Trade Name: BIRMINGHAM HIP RESURFACING SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S011
Date Received: 04-17-2009
Decision Date: 06-09-2009
Advisory Committee: OR
Supplement Type: REAL-TIME PROCESS
Product Code: NXT (Search Manufacturers)
Supplement Reason: LABELING CHANGE – INSTRUCTIONS
Approval Order Statement:
APPROVAL FOR THE MODIFICATION OF THE BHR/R3 MODULAR RESURFACING SURGICAL TECHNIQUE ADDENDUM.
Trade Name: BIRMINGHAM HIP RESURFACING SYSTEM, REFLECTION CERAMIC ACETABULAR HIP SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH & NEPHEW, INC.
PMA Number: P040033
Supplement Number: S012
Date Received: 07-22-2009
Decision Date: 10-07-2009
Advisory Committee: OR
Supplement Type: 135 REVIEW TRACK FOR 30-DAY NOTICE
Product Code: NXT (Search Manufacturers)
Supplement Reason: PROCESS CHANGE: MANUFACTURING
Approval Order Statement:
APPROVAL FOR THE USE OF NEW MANUFACTURING EQUIPMENT USED TO PRECLEAN DEVICES.
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S013
Date Received: 07-22-2009
Decision Date: 12-31-2009
Advisory Committee: OR
Supplement Type: 135 REVIEW TRACK FOR 30-DAY NOTICE
Product Code: NXT (Search Manufacturers)
Supplement Reason: PROCESS CHANGE: MANUFACTURING
Approval Order Statement:
APPROVAL FOR A CHANGE TO NEW TESTING EQUIPMENT USED FOR MEASURING SURFACE FINISH, TAPE ANGLE, AND DIAMETER FOR THE R3 METAL LINERS.
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S014
Date Received: 11-13-2009
Decision Date: 12-11-2009
Advisory Committee: OR
Supplement Type: SPECIAL(IMMEDIATE TRACK)
Product Code: NXT (Search Manufacturers)
Supplement Reason: LABELING CHANGE – OTHER
Approval Order Statement:
APPROVAL FOR REVISIONS TO THE PHYSICIAN AND PATIENT LABELING.
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S015
Date Received: 01-11-2010
Decision Date: 03-09-2010
Advisory Committee: OR
Supplement Type: REAL-TIME PROCESS
Product Code: NXT (Search Manufacturers)
Supplement Reason: CHANGE DESIGN/COMPONENTS/SPECIFICATIONS – COMPONENT
Approval Order Statement:
APPROVAL FOR THE ADDITION OF SURGICAL INSTRUMENTS FOR USE WITH THE BHR SYSTEM AND AN UPDATE TO THE SURGICAL TECHNIQUE TO REFLECT THE NEW SURGICAL INSTRUMENTS.
Trade Name: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic Name: TOTAL HIP RESURFACING PROSTHESIS, METAL-ON-METAL
Applicant: SMITH&NEPHEW ORTHOPAEDICS
PMA Number: P040033
Supplement Number: S016
Date Received: 09-14-2010
Decision Date: 10-13-2010
Advisory Committee: OR
Supplement Type: SPECIAL(IMMEDIATE TRACK)
Product Code: NXT (Search Manufacturers)
Supplement Reason: LABELING CHANGE – INSTRUCTIONS
Approval Order Statement:
APPROVAL FOR REVISIONS TO THE PHYSICIAN AND PATIENT LABELING.
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