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510(k) Data Aggregation
K Number
K043346Device Name
GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
Manufacturer
GENESIS MEDICAL L.L.C.
Date Cleared
2005-01-31
(56 days)
Product Code
KWS
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
GENESIS MEDICAL L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Total shoulder or hemi-shoulder replacement is indicated for:
- 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
- 2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
- Other difficult clinical problems where shoulder arthrodesis or 3. resection arthroplasty are not acceptable (e.g., revision of a failed primary component).
Hemi-shoulder replacement is also indicated for:
- 1. Ununited humeral head fractures.
- 2. Avascular necrosis of the humeral head.
Device Description
The humeral stem is manufactured from titanium 6-Al-4V alloy and has a corundum blasted surface to enhance bone cement fixation. Lateral fins with suture holes are designed for soft tissue attachment. There is a 6 degree male taper to mate with humeral heads. The devices features an anatomical neck/shaft angle. The humeral head is fabricated from cobalt chromium alloy. The head has a low profile and manufactured with a 6 degree taper to mate with the humeral stem. There are numerous head diameters to accommodate anatomical patient variations. An offset head at 4 mm is also available to permit soft tissue balancing and to enhance joint stability. The glenoid component is fabricated from ultra-high molecular-weight polyethylene. It is designed with a pear shaped frontal profile for anatomical fit to the glenoid which avoids soft tissue impingement. The articular surface radius of curvature is oversized to the humeral heads to accommodate multiple humeral head sizes. The device is designed with 3 peg fixation. The pegs are co-linear to help avoid punch through of thin cortical walls at the outer edges of the glenoid. The undersurface is keeled to enhance bone cement fixation.
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