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Orthopaedic Innovations Renewal Acetabular Cup System
Orthopaedic Innovations
Summary: The Renewal Acetabular Cup System is an orthopedic implant used in hip replacement surgeries. It is primarily utilized by orthopedic surgeons to restore joint function in patients with hip joint degeneration.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K020145 ↗
Decision Date ?
April 15, 2002
Product Code ?
LPH
Device Class ?
Class 2
Evidence ?
10 studies
The Renewal Acetabular Cup System by Orthopaedic Innovations was cleared through the FDA 510k pathway on April 15, 2002. It is classified as a Class 2 medical device under product code LPH.
What It Is
The Renewal Acetabular Cup System is a component of hip prostheses used in total hip arthroplasty. It is designed to replace the acetabulum, the socket portion of the hip joint, in patients suffering from severe arthritis or hip fractures. The device is typically made from biocompatible materials such as metal alloys and polyethylene, allowing for durable and smooth joint articulation.
FDA-Cleared Indications
- Replacement of the acetabular component during total hip arthroplasty.
- Use in patients with degenerative joint disease of the hip, including osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
- Use in patients requiring hip joint reconstruction after conditions such as hip fracture, when total hip replacement is indicated.
Clinical Applications
- Acetabular replacement during primary total hip arthroplasty.
- Treatment of painful hip osteoarthritis requiring total hip replacement.
- Treatment of rheumatoid or traumatic arthritis of the hip requiring joint reconstruction.
- Reconstruction of the hip joint in selected patients with traumatic hip damage or fracture.
Practical Considerations
- The system is available in different sizes; selection depends on the patient's acetabular anatomy, bone quality, and the other planned hip prosthesis components.
- The cup must be used with compatible femoral and bearing components according to the manufacturer's instructions for use.
- Implantation is performed surgically, generally with regional or general anesthesia, and requires appropriate preparation of the acetabulum.
- Potential contraindications and risks include active infection, inadequate bone stock, allergy or sensitivity to implant materials, loosening, dislocation, wear, fracture, and the need for revision surgery.
- MRI safety depends on the complete implanted construct and its materials. The current device labeling and MRI conditions should be reviewed before scanning.
Linked Studies (10)
PubMed • 2025
Innovations in peritoneal dialysis fluid: biocompatible formulations and expanded therapeutic applications.
Renal failure
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Artificial Intelligence in Valvular Heart Disease: Innovations and Future Directions.
JACC. Cardiovascular interventions
View Source →PubMed • 2025
3D printing innovations in catheter design to reduce catheter-associated infections: a scoping review.
Journal of biomaterials science. Polymer edition
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Improving Foley Catheter Insertion Procedure by Developing Foley Introducer: A 100-Year Overdue Innovation.
International neurourology journal
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Digital innovations for retinal care in diabetic retinopathy.
Acta diabetologica
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2020
Innovations in indwelling urethral catheterisation.
BJU international
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2017
Improvement of patient eligibility with the use of new generation endografts for the treatment of abdominal aortic aneurysms. A comparison study among currently used endografts and literature review.
Expert review of medical devices
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2014
Technical innovation in minimally invasive repair of pectus excavatum.
Pediatric surgery international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Renewal Acetabular Cup System used for?
It is used in total hip replacement surgeries to replace the acetabulum in patients with hip joint degeneration.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement surgeries typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with degenerative joint diseases of the hip, such as arthritis or fractures requiring hip replacement.
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.