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510(k) Data Aggregation
K Number
K123782Device Name
PARAGON HIP SYSTEM
Manufacturer
GLOBAL MANUFACTURING TECHNOLOGY
Date Cleared
2013-03-14
(94 days)
Product Code
LZO, MEH
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL MANUFACTURING TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paragon™ Hip System is intended for use as the femoral component of a total hip replacement or partial hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
1. Degenerative osteoarthritis of the hip.
2. Inflammatory arthritis of the hip.
3. Secondary arthritis of the hip, such as may follow trauma (e.g. fracture of the femoral neck, or fracture and/or dislocation of the hip or acetabulum), or congenital conditions (e.g. developmental dysplasia of the hip).
4. Displaced intracapsular femoral neck fractures where there is a high risk of non-union or avascular necrosis and bone collapse.
5. Avascular Necrosis of the femoral head.
6. Revision of a failed femoral component from previous hip surgery e.g. internal fixation device from previous osteotomy, fracture treatment or hemi-arthroplasty.
Device Description
The Paragon™ Hip System is to be used in conjunction with a compatible femoral head and acetabular component as part of a total hip arthroplasty, or as the femoral stem in a hemiarthroplasty. The body of the Paragon™ Hip System tapers proximal to distal in the lateral and frontal planes, and lateral to medial in the sagittal plane resulting in a bi-planar wedge geometry that is conducive to axial and rotational stability. The Paragon™ Hip System is manufactured from titanium alloy (Ti6A14V ELI per ASTM F136) and Hydroxyapatite (HA) (ISO 13779-1 for the HA powder and ISO 13779-2 for the coating).
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K Number
K113107Device Name
MSA HIP SYSTEM
Manufacturer
GLOBAL MANUFACTURING TECHNOLOGY
Date Cleared
2011-12-15
(56 days)
Product Code
MEH, LZO
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL MANUFACTURING TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MSA Hip System is indicated for cementless use and is intended to replace a hip joint.
The device is intended for:
- skeletally mature individuals undergoing primary surgery for total hip replacement
- patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fracture of the femur.
- patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis
- patients suffering from disability due to previous fusion
- patients with acute femoral neck fractures
Device Description
The MSA Hip System is a modular hip system consisting of a short stem which mates with a modular neck. The hip stems are made of Ti-6AI-4V (ASTM F136) with a commercially pure titanium plasma spray coating (ASTM F1580) on the proximal end. The stems are available with and without a hydroxyapatite coating. The modular necks are made of CoCr alloy (ASTM F1537). The MSA Hip System can be mated with metal or ceramic femoral heads and acetabular components.
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K Number
K102172Device Name
MSA HIP SYSTEM
Manufacturer
GLOBAL MANUFACTURING TECHNOLOGY
Date Cleared
2011-03-01
(211 days)
Product Code
MEH, THE
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL MANUFACTURING TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MSA Hip System is indicated for cementless use and is intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fracture of the femur. patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis patients suffering from disability due to previous fusion patients with acute femoral neck fractures
Device Description
The MSA Hip System is a modular hip system consisting of a short stem which mates with a modular neck. The proximal portion of the stem has a plasma spray coating and a hydroxyapatite coating. The MSA Hip System can be mated with a number of previously cleared femoral heads and acetabular components. The hip system is intended for cementless implantation. The hip stems are made of Ti-6AI-4V (ASTM F136) with a commercially pure titanium plasma spray coating (ASTM F1580) and the modular necks are made of CoCr alloy (ASTM F1537).
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