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510(k) Data Aggregation
K Number
K063278Device Name
PORTLAND COBALT CHROME FEMORAL HEAD
Manufacturer
PORTLAND ORTHOPAEDICS LIMITED
Date Cleared
2007-01-12
(73 days)
Product Code
JDI, LPH, MEH
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
PORTLAND ORTHOPAEDICS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Portland Cobalt Chrome Femoral Head has the following indications for use:
• The patient should be skeletally mature.
• The patient's condition should be due to one or more of the following:
1. Osteoarthritis.
2. Rheumatoid arthritis.
3. Tumor conditions involving the upper third of the femur or of the Acetabular.
4. Ankylosing spondylitis.
5. Psoriatic arthritis.
6. Old osteomyelitis - with a long infection-free period and a normal WBC, ESR and C-reactive protein.
7. Non union of femoral neck fracture or avascular necrosis of the femoral head.
8. Post-traumatic fracture/dislocation of the hip.
9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
Device Description
The Portland Cobalt Chrome Femoral Head is provided as a single component. The device is manufactured from a cobalt chrome alloy and is available in various sizes. The internal bore of the femoral head is designed to taper lock (12/14) with the external male taper on a Portland Orthopaedics femoral hip stem providing articulation with a suitable acetabular module.
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