BIRMINGHAM HIP TRIAL HEAD 48MM

BIRMINGHAM HIP TRIAL HEAD 48MM
BIRMINGHAM HIP - 90051048

A copy of a final femoral head prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size, and to help achieve the desired offset, leg-length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral stem trial or final prostheses; some may be used with explantation instruments during removal of implanted acetabulum cups. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. This is a reusable device intended to be sterilized prior to use.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: NXT

Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

Device Class: 3

Physical State: The femoral resurfacing component and acetabular components are made of metal. These surfaces rub against each other (the bearing couple) and are made from highly-polished metal. This type of bearing couple is called a metal-on-metal bearing couple.

Definition: Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases. This device is indicated for patients with degenerative joint diseases including osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis and for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.

Submission Type ID: 2

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Prosthesis, hip, semi-constrained, metal/metal, resurfacing device has two parts: a socket in the shape of a shallow cup (acetabular component), and a cap in the form of a ball head (femoral resurfacing component). The cup replaces the damaged surface of the hip socket (acetabulum). The cap covers or resurfaces the ball-shaped bone at the top of the thigh (femoral head), and the cap has a small stem that is inserted into the top of the thighbone. The cap moves within the cup.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: The device is to replace the hip joint.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 03596010584397

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A