Search Results
Found 5 results
510(k) Data Aggregation
K Number
K061564Device Name
PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
Manufacturer
PORTLAND ORTHOPAEDICS PTY. LTD.
Date Cleared
2006-09-01
(88 days)
Product Code
LZO
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
PORTLAND ORTHOPAEDICS PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Portland Ceramic (Biolox-Forte) Femoral Head has the following indications for use:
• The patient should be skeletally mature.
· The patient's condition should be due to one or more of the following:
1. Osteoarthritis.
2. Rheumatoid arthritis.
3. Tumor conditions involving the upper third of the femur or of the Acetabular.
4. Ankylosing spondylitis.
5. Psoriatic arthritis.
6. Old osteomyelitis - with a long infection-free period and a normal WBC, ESR and Creactive protein.
7. Non union of femoral neck fracture or avascular necrosis of the femoral head.
8. Post-traumatic fracture/dislocation of the hip.
9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
Device Description
The Portland Portland Ceramic (Biolox-Forte) Femoral Head is provided as a single component. The device is manufactured from an Alumina Oxide (Biolox-Forte) and is available in various sizes. The internal bore of the femoral head is designed to taper look (12/14) with the external male taper on a femoral hip stem providing articulation with a suitable acetabular module.
Ask a Question
K Number
K053417Device Name
M-COR HIP REPLACEMENT SYSTEM
Manufacturer
PORTLAND ORTHOPAEDICS PTY. LTD.
Date Cleared
2006-07-20
(224 days)
Product Code
LPH, KWY, LZO
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
PORTLAND ORTHOPAEDICS PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The M-COR Modular Hip System has the following indications for use:
- · The patient should be skeletally mature.
- · The patient's condition should be due to one or more of the following:
- Osteoarthritis. 1.
- 2. Rheumatoid arthritis.
- 3. Ankylosing spondylitis
- 4. Psoriatic arthritis.
- 5. Tumor conditions involving the upper third of the femur or of the acetabulum
- Old osteomyelitis with a long infection-free period and a normal WBC, ESR 6. and C-reactive protein.
- 7. Non-union of femoral neck fracture or avascular necrosis of the femoral head.
- 8. Post-traumatic fracture/dislocation of the hip.
- Revision of an unsuccessful arthrodesis with either poor positioning or pain in 9. the hip, or where low back pain or knee pain is becoming disabling.
- 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
- 11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
Device Description
The M-COR (Modular – Center of Rotation) Hip Replacement System is a modular femoral neck and stem component system, to be used for cementless applications.
The M-COR Hip Replacement System is comprised of two units: the first is a Commercially Pure Titanium (CPT) coated femoral stem component manufactured from titanium alloy (Ti-6Al-4V). The second is a femoral neck component from either titanium alloy (Ti-6Al-4V) or cobalt-chrome.
Ask a Question
K Number
K051844Device Name
EQUATOR PLUS ACETABULAR CUP SYSTEM
Manufacturer
PORTLAND ORTHOPAEDICS PTY. LTD.
Date Cleared
2005-10-07
(92 days)
Product Code
MAY, JDI, LWJ
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
PORTLAND ORTHOPAEDICS PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Equator Plus™ Acetabular Cup System has the following indications for use:
- The patient should be skeletally mature.
- The patient's condition should be due to one or more of the following:
1. Osteoarthritis.
2. Rheumatoid arthritis.
3. Tumor conditions involving the upper third of the femur or of the Acetabular.
4. Ankylosing spondylitis.
5. Psoriatic arthritis.
6. Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein.
7. Non union of femoral neck fracture or avascular necrosis of the femoral head.
8. Post-traumatic fracture/dislocation of the hip.
9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
Device Description
The Equator Plus™ Acetabular Cup System is comprised of two units the first is a coated outer shell manufactured from titanium alloy (Ti-6A1-4V). The second unit is a ultra high molecular weight polyethylene (UHMWPE) liner force fitted into an outer cobalt chrome metal dome casing. The UHMWPE liner is provided as a single pre-assembled component. The Equator Plus™ Acetabular Cup System is to be used as part of a modulary total hip replacement system in a cementless application.
Ask a Question
K Number
K032641Device Name
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
Manufacturer
PORTLAND ORTHOPAEDICS PTY. LTD.
Date Cleared
2004-01-20
(146 days)
Product Code
MEH, LPH
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
PORTLAND ORTHOPAEDICS PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MARGRON™ Hip Replacement System is intended for primary or revision restruction, without bone cement, of the femoral portion of a severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. The patient should be skeletally mature. The patient's condition should be due to one or more of the following: Osteoarthritis, Rheumatoid arthritis, Tumor conditions involving the upper third of the femur or the acetablym, Ankylosing spondylitis, Psoriatic arthritis, Old osteomyelitis - with a long infection-free period and a normal WBC. ESR and C-reactive protein, Non union of femoral neck fracture or avascular necrosis of the femoral head, Post-traumatic fracture/dislocation of the hip, Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling, Revision of an unsuccessful cemented or un-cemented hip replacement stem, providing sufficient bone stock is present, Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
Device Description
The MARGRON 100 hip replacement stem has been designed to be used in an uncemented mode in bone which is of good quality physiologically and which will heal quickly. The MARGRON TM Femoral Stem is a modular prosthesis consisting of - A tapering stem cone with two different speed external threads and longitudinal . derotation columns. - A neck component which allows the optimum angle of anteversion to be selected ● after stem insertion. - . Precision milling and tapping is used to prepare the femur and stem insertion is by "screw home" rotation. - . A unique set of instruments have been designed to insert and extract the prosthesis.
Ask a Question
K Number
K992815Device Name
THE MARGRON HIP REPLACEMENT SYSTEM
Manufacturer
PORTLAND ORTHOPAEDICS PTY. LTD.
Date Cleared
2000-02-07
(171 days)
Product Code
MEH, POR
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
PORTLAND ORTHOPAEDICS PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Margron™ Hip Replacement System is intended for primary or revision restruction, without bone cement, of the femoral portion of a severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present.
The patient should be skeletally mature. The patient's condition should be due to one or more of the following:
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis
- Psoriatic arthritis
- Old osteomyelitis with a long infection free period and a normal WBC, C- Reactive protein and ESR
- Non union of femoral neck fracture or avascular necrosis of the femoral head
- Post-traumatic fracture/dislocation of the hip
- Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling
- Revision of an unsuccessful uncemented or cemented hip replacement stem, providing sufficient bone stock is present
- Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
Device Description
The Margron™ hip replacement stem has been designed to be used in an uncemented mode in bone which is of good quality physiologically and which will heal quickly.
The Margron™ Femoral Stem is a modular prosthesis consisting of:
- A tapering stem cone with two different speed external threads and longitudinal derotation columns.
- A neck component which allows the optimum angle of anteversion to be selected after stem insertion.
- Precision milling and tapping is used to prepare the femur, and stem insertion is by 'screw home' rotation.
- A unique set of instruments have been designed to insert and extract the prosthesis.
Ask a Question
Page 1 of 1