đź“‹ FDA Reference
Tillman Hip Resurfacing Replacemt Pros
Summary: The Tillman Hip Resurfacing Replacement Pros is a hip resurfacing implant used in orthopedic surgery to treat hip joint conditions. It is primarily used by orthopedic surgeons for patients with hip arthritis or other degenerative joint diseases.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K792200 ↗
Decision Date ?
December 5, 1979
Product Code ?
KXA
Device Class ?
Class 2
Evidence ?
0 studies
The Tillman Hip Resurfacing Replacement Pros was cleared through the FDA 510k pathway on December 5, 1979. Manufactured by Waldemar Link Gmbh & Co. Kg, it is classified as a Class 2 device under product code KXA.
What It Is
The Tillman Hip Resurfacing Replacement Pros is a medical device designed for hip resurfacing procedures. It involves capping the femoral head with a metal prosthesis while preserving more of the patient's natural bone compared to traditional hip replacements. This device is intended to alleviate pain and improve mobility in patients with hip joint damage.
FDA-Cleared Indications
- Use in hip resurfacing procedures for patients with severe hip joint damage requiring surgical treatment.
- Treatment of degenerative disease of the hip associated with pain and loss of function.
- Use in patients for whom restoration of hip joint function and pain relief are indicated.
Clinical Applications
- Hip resurfacing for symptomatic osteoarthritis or other severe degenerative hip disease.
- Hip resurfacing when the femoral head can be prepared to receive a resurfacing cap.
- Surgical treatment of hip joint damage when preservation of femoral bone is part of the treatment plan.
Practical Considerations
- The implant is available in multiple sizes; the surgeon selects components based on the patient's anatomy, bone quality and surgical findings.
- Hip resurfacing requires adequate femoral-head bone stock and is not appropriate for every patient with hip pain or arthritis.
- The procedure is performed by an orthopedic surgeon in an operating room, usually with regional or general anesthesia.
- The implant is a metal orthopedic device. MRI safety and artifact information should be confirmed from the current implant documentation before scanning.
- Potential complications include infection, fracture, dislocation, loosening, wear, adverse tissue reactions and the need for revision surgery.
Frequently Asked Questions
What is Tillman Hip Resurfacing Replacement Pros used for?
It is used for hip resurfacing procedures to treat conditions like osteoarthritis and avascular necrosis in the hip joint.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement and hip surgery commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients with severe hip joint damage due to degenerative diseases requiring surgical intervention.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.