📊 Evidence-Based Reference
Tillman Hipsurface Replacement
Summary: The Tillman Hipsurface Replacement is a hip resurfacing device used primarily in orthopedic oncology. Key evidence includes consensus on periprosthetic infection management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781490 ↗
Decision Date ?
September 20, 1978
Product Code ?
KXA
Device Class ?
Class 2
Evidence ?
0 studies
The Tillman Hipsurface Replacement was cleared via the FDA 510(k) pathway on September 20, 1978. It is manufactured by Waldemar Link Gmbh & Co. Kg and classified as a Class 2 device.
What It Is
The Tillman Hipsurface Replacement is a hip resurfacing device designed to replace the surface of the hip joint. It is intended for use in patients requiring hip joint reconstruction, particularly in orthopedic oncology settings.
FDA-Cleared Indications
- Hip joint reconstruction requiring replacement of the articular surface
- Reconstruction of the hip joint in patients with tumor-related orthopedic conditions
- Replacement of damaged or degenerated hip joint surfaces when hip resurfacing is selected
Clinical Applications
- Hip resurfacing as an alternative to selected forms of total hip replacement
- Reconstruction of the hip joint after orthopedic tumor treatment
- Replacement of damaged femoral head and acetabular articular surfaces
- Hip joint reconstruction when preservation of additional native bone is clinically appropriate
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and retrospective analyses, with publication years ranging from 2019 to 2025. These studies explore topics like periprosthetic infection and global disparities in sarcoma care.
Reported Outcomes
Published studies report consensus on managing periprosthetic infections in orthopedic oncology. The device is noted for its role in preserving bone and providing effective joint function in tumor-related cases.
Safety Profile
Reported complications include periprosthetic infections, as highlighted in consensus studies. Safety data is limited, emphasizing the need for further research on long-term outcomes.
Evidence Limitations
Current evidence is limited by a lack of large-scale, long-term studies. There is a need for more comprehensive data on safety and efficacy, particularly in diverse patient populations.
Practical Considerations
- The appropriate implant size and component configuration depend on the patient's hip anatomy, bone quality and reconstruction needs.
- This is an orthopedic implant, not an endovascular or catheter-based device; implantation requires open orthopedic surgery.
- MRI safety and conditional scanning requirements should be confirmed from the device labeling or implant documentation. Patients should provide the exact implant information before MRI.
- Contraindications may include active infection, inadequate bone stock, severe bone or soft-tissue compromise, and medical conditions that make major orthopedic surgery unsafe.
- Long-term implant performance depends on fixation, implant positioning, patient activity, bone quality and the underlying diagnosis.
Frequently Asked Questions
What are the clinical indications for Tillman Hipsurface Replacement?
The device is indicated for hip joint reconstruction in patients with conditions such as tumors, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective joint function and bone preservation, with consensus on managing periprosthetic infections.
What complications have been reported?
Reported complications include periprosthetic infections, with limited data on other potential adverse events.
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.