đź“‹ FDA Reference
Apex Modular Acctabular Cup Now Named Apex Interface Acetabular System
Omnlife Science
Summary: The Apex Interface Acetabular System is a modular hip replacement component used in orthopedic surgeries. It is typically utilized by orthopedic surgeons for patients requiring hip joint reconstruction.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K112779 ↗
Decision Date ?
December 2, 2011
Product Code ?
LPH
Device Class ?
Class 2
Evidence ?
0 studies
The Apex Interface Acetabular System was cleared through the FDA 510k pathway on December 2, 2011. Manufactured by Omnlife Science, it is classified as a Class 2 device under product code LPH.
What It Is
The Apex Interface Acetabular System is a modular component used in hip arthroplasty procedures. It serves as the acetabular cup, a critical part of the hip joint replacement, allowing for articulation with the femoral head. The system is designed to provide stability and durability, accommodating various patient anatomies through its modular design.
FDA-Cleared Indications
- Acetabular component use in total hip arthroplasty for hip joint reconstruction.
- Treatment of adults requiring hip reconstruction because of degenerative joint disease, trauma, or fracture, when use is consistent with the device labeling.
Clinical Applications
- Primary total hip arthroplasty using a modular acetabular cup.
- Hip joint reconstruction for osteoarthritis or other degenerative hip disease.
- Hip reconstruction associated with rheumatoid arthritis.
- Acetabular reconstruction after traumatic injury or hip fracture when total hip replacement is indicated.
Practical Considerations
- The system is modular and is available in multiple component sizes; selection depends on acetabular anatomy, bone quality, and the planned bearing combination.
- It is intended for use with compatible hip arthroplasty components according to the manufacturer’s surgical technique and labeling.
- The implant is placed through an orthopedic surgical approach under general or regional anesthesia, with imaging and intraoperative assessment used as clinically appropriate.
- MRI safety and conditional scanning requirements depend on the complete implanted construct and its labeling; the specific implant records should be reviewed before MRI.
- Contraindications and precautions include active infection, inadequate bone stock, unsuitable anatomy, metal or implant-material allergy, and medical conditions that make major orthopedic surgery unsafe.
Frequently Asked Questions
What is the Apex Interface Acetabular System used for?
It is used in hip replacement surgeries to replace the acetabular component of the hip joint.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement or reconstructive surgery typically use this device.
What are the FDA-cleared indications?
The device is indicated for hip joint reconstruction in patients with conditions like osteoarthritis, rheumatoid arthritis, or hip fractures.
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.