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510(k) Data Aggregation
K Number
K061862Device Name
AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
Manufacturer
AXIOM ORTHOPAEDICS, INC.
Date Cleared
2006-08-28
(59 days)
Product Code
HSD
Regulation Number
888.3690Why did this record match?
Applicant Name (Manufacturer) :
AXIOM ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Axiom Orthopaedics Shoulder Resurfacing System is intended as a hemi shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device will increase shoulder mobility by reducing pain, restoring alignment, restoring flexion and extension movement, and resisting dislocation.
The Axiom Orthopaedics Shoulder Resurfacing System is indicated for use as a replacement of shoulder joints disabled by
- Rheumatoid arthritis with pain 1.
- 2. Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- 3. Correction of functional deformity
- 4. Fractures of the humeral head
- 5. Traumatic arthritis.
These components are single use only and are intended for cementless use.
Device Description
The Axiom Orthopaedics Shoulder Resurfacing System is a series of humeral heads that are designed to articulate with a resurfaced or non-resurfaced Glenoid fossa. The proposed humeral heads are manufactured from cobalt chromium alloy (ASTM F-75) and can be used as either a left or right configuration. The interior surface of the proposed Axiom components contains a pattern of buttressed protrusions that help restrict rotation of the device. In addition to the buttressed protrusion pattern, the interior surface is coated with a plasma spray titanium substrate and a calcium phosphate coating (ASTM 1044 and ASTM 1147, respectively). The proposed humeral heads have been designed to mimic the normal humeral head geometry by employing a non-spherical accurate shape. The shape of the humeral heads does not exceed the radius of curvature of the reamed Glenoid fossa. This helps to maintain contact between the humeral head and the Glenoid fossa throughout the range of motion. The humeral heads are available in 14 sizes.
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