BIRMINGHAM HIP DYSPLASIA SCREW - 76MM

BIRMINGHAM HIP DYSPLASIA SCREW
BIRMINGHAM HIP RESURFACING (BHR) - 74500076

An implantable partial substitute for a disease-damaged hip joint intended to replace the articulating surfaces of the hip while preserving the natural femoral head and neck. It consists of a metallic femoral cap component, that is placed over (resurfaces) a surgically-prepared femoral head, and a metallic acetabular component; that is, both components are supplied together. Fixation devices for implantation (e.g., screws/bolts) may be included and implantation may be performed with or without bone cement. This device is commonly used for younger/active patients to avoid total hip replacements/revisions.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: 03596010502957

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