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510(k) Data Aggregation
(224 days)
The implaFit® short stems are intended to be used in total hip arthroplasty for the following indications:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
- Revision of previously failed total hip arthroplasty.
The implaFit® short stems are intended for uncemented, press-fit fixation.
The implaFit® short stems are intended to be used in partial (hemi) hip arthroplasty in conjunction with the ic-Bipolar Head System for the following indications:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
The components introduced with this submission are intended to mate with other previously cleared components to make a complete prosthesis. The implaFit® short stem with collar cementless are offered in standard and lateralized offset versions. The components included in this submission consist of titanium alloy femoral hip stems, used in total and hemi hip arthroplasty and are intended for uncemented press fit application.
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