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510(k) Data Aggregation
K Number
K132539Device Name
RING-LOK MODULAR BIPOLAR SYSTEM
Manufacturer
Date Cleared
2014-02-07
(178 days)
Product Code
Regulation Number
888.3390Why did this record match?
Applicant Name (Manufacturer) :
IMPLANTS INTERNATIONAL, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ring-Lok™ Modular Bi-Polar System is intended for use in combination with other previously cleared femoral components including the Rig-Fix™ Hip Stem (K072101), C-fit Performa (K923898) or the Stability Hip Stem (K915787 and K934457) for uncemented primary or revision hemi-arthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- Femoral neck and trochanteric fractures of the proximal femur .
- Osteonecrosis of the femoral head .
- Revision procedures where other treatments or devices or these indications have failed.
Device Description
The Ring-Lok™ Modular Bi-Polar System is intended for use in combination with the previously cleared femoral components including Rig-Fix™ Hip Stem (K072101), C-fit Performa (K923898) or the Stability Hip Stem (K915787 and K934457)). The Ring-Lok™ Modular Bipolar System consists of a factory assembled UHMWPE liner in a cobalt chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 62 mm, in 1mm increments, to properly fit the patient anatomy. The inner diameter mates with a 22.225, 26 or 28 mm diameter femoral head.
Implant International supplies Ring-Lok™ Bi-Polar Instrumentation for use with the Ring-Lok™ Modular Bi-Polar System.
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K Number
K071583Device Name
CERMET III ACETABULAR CUP SYSTEM
Manufacturer
Date Cleared
2007-07-25
(47 days)
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
IMPLANTS INTERNATIONAL, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CER-MET™ III Acetabular Cup System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
Device Description
The CER-MET™ III Acetabular Cup System is a non-cemented acetabular cup system with a complete assortment of neutral and 10° hooded poly inserts as well as acetabular screws and screw hole covers (screw hole occluders).
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