Search Results
Found 2 results
510(k) Data Aggregation
K Number
K173455Device Name
SurgTech Bipolar Head System
Manufacturer
Date Cleared
2018-06-14
(219 days)
Product Code
Regulation Number
888.3390Why did this record match?
Applicant Name (Manufacturer) :
SurgTech, Inc.,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SurgTech Bipolar Head system is intended for use for cases of:
• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- · Inflammatory degenerative joint disease such as rheumatoid arthritis.
- Correction of function deformity.
- · Revision procedures where other treatments or devices have failed.
· Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Device Description
The SurgTech Bipolar Head System is used for hip hemiarthroplasty in skeletally mature individuals. The system consists of a CoCr alloy shell (38-58mm outer diameters), a polyethylene bearing insert (22mm and 28mm inner diameters) and retaining ring, and CoCr alloy femoral heads (22mm and 28mm) in various offsets. Instrumentation necessary for proper implantation is also included.
Ask a Question
Ask a specific question about this device
K Number
K162125Device Name
MALUC Total Hip Arthroplasty System
Manufacturer
Date Cleared
2017-05-10
(282 days)
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
SurgTech, Inc.,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SurgTech MALUC™ System is intended for use for cases of severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty and/or total arthroplasty), and certain cases of ankylosis.
Device Description
The MALUC™ Total Hip Arthroplasty System is used for primary total hip replacement in skeletally mature individuals. The system consists of monolithic cemented and press-fit femoral stems, modular CoCr and BIOLOX® delta femoral heads in various sizes and offsets, uncemented acetabular shells and conventional polyethylene liners. Accessory components include distal centralizers, cancellous bone screws and cement restrictors. Instrumentation necessary for proper implantation is also included.
Ask a Question
Ask a specific question about this device
Page 1 of 1