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510(k) Data Aggregation
K Number
K992359Device Name
MRS-TITAN
Manufacturer
Date Cleared
2000-02-18
(219 days)
Product Code
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
ROTEC MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MRS-Titan system is intended to be used as the acetabular part of a hip arthroplasty. The indications for use of the MRS-Titan system are revision operations and fractures of primary hip operated patients, especially with large bone defects in the acetabulum, as well as tumour situations at the acetabulum.
Painful, disabling joint diseases of the hip resulting from degeneration, arthritis, rheumatoid arthritis, post traumatic arthritis.
Revision of previous unsuccessfull femoral head replacement, cup arthroplasty or other procedure.
Clinical management problem solve arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated deficiencies of the acetabulum.
Device Description
The patientmatched modular revision acetabular system MRS-Titan was developed to achieve best fixation of the cup in the acetabulum by using a cementless bone fixation technique. Depending on the needed diameter the surgeon is able to decide the size between Ø 48 mm and Ø 64 mm in 4 mm steps. All diameters are able to be used either with a caudal hook and a strap, two straps or only with two straps. In general the caudal hook is designed to fix the original center of rotation because generally the use of MRS-Titan is intended after the second, third or fourth revision operation at the natural acetabulum. Typically this condition shows a very bad boney situation. So this device allows the surgeon to create a good remodelling of the acetabular bone as well as a good mechanical stabilisation of the cup. In comparison to other systems having received the SEletter the straps are not fixed in one angle, rotation allows to adapt the straps in best angle situation the patient needs. The MRS components are single-use devices.
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K Number
K992403Device Name
MRP-TITAN
Manufacturer
Date Cleared
2000-01-21
(186 days)
Product Code
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
ROTEC MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MRP-Titan system is intended to be used as the proximal part of a hip stem arthoplasty. The indications for use of the MRP-Titan system are revision operations and femur fractures of primary hip operated patients as well as tumour situations at the femur.
Primary and revision arthroplasty: Revision of primary hip stem prostheses
Fractures of the proximal femur
Tumor situation of the proximal femur
Reconstructions of the upper area of the proximal femur after both primary hip operation or traumafracture
Recovery of leg-lengthening
Improving antetorsion after failed primary hip stem operation
Device Description
The patientmatched modular revision hip system MRP-Titan was developed to achieve best fixation of the stem in the femur canal by using a star-shaped design. Depending on the needed length the surgeon is able to decide using the sleeve or not. All necks are available in three sizes to achieve the total length needed. The use of the instruments and the single step to assemble the system is shown very clearly in the enclosed pictures.
The MRP-Titan components are single-use devices.
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