Renewal Acetabular Cup System
by Orthopaedic Innovations, Inc.
510(k) K020145
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020145 | Date15 Apr 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Orthopaedic Innovations Renewal Acetabular Cup System
- 510(k) Number
- FDA Product Code
- LPH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3358
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Renewal Acetabular Cup System is a Hip Prosthesis, Acetabular Component (FDA Product Code LPH) designed to replace the acetabulum in total hip arthroplasty. It is intended for use in primary or revision surgeries to restore function and alleviate pain in severely damaged hip joints, where sufficient bone integrity is present. Constructed from biocompatible materials, the system facilitates durable articulation within the hip joint, accommodating both cemented and uncemented fixation options. Its design addresses degenerative conditions such as severe arthritis or post-traumatic hip defects.
This device is supplied as a modular component for surgical use in orthopaedic settings, with sterility and single-use considerations dictated by manufacturer guidelines. It is regulated under FDA 510(k) clearance (K020145) and classified under the Orthopaedic Orthopedic Orthopedic advisory committee. The system is available in predefined sizes and configurations to match anatomical requirements, though specific dimensions are not detailed in the regulatory submission. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to implantation.
Other devices from Orthopaedic Innovations, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Renewal Acetabular Cup System used for?
The Renewal Acetabular Cup System is designed for total hip arthroplasty, replacing the damaged acetabulum in primary or revision surgeries. It is intended for patients with severe hip joint conditions, such as degenerative arthritis or post-traumatic defects, where sufficient bone integrity remains. The system helps restore joint function and relieve pain by providing durable articulation within the hip.
How is the Renewal Acetabular Cup System supplied and prepared for surgery?
The system is supplied as a modular component for surgical use in orthopaedic settings. It is intended for single-use, with sterility maintained according to manufacturer guidelines. Proper storage and handling must comply with sterile medical device protocols to ensure the device remains intact and uncontaminated before implantation.
Is the Renewal Acetabular Cup System available in multiple sizes?
Yes, the Renewal Acetabular Cup System is available in predefined sizes and configurations to accommodate varying anatomical requirements. While specific dimensions are not detailed in the regulatory submission, the modular design allows for flexibility in matching patient-specific needs during surgery.
Can the Renewal Acetabular Cup System be used with cement or without?
The system is designed to accommodate both cemented and uncemented fixation options. This versatility allows surgeons to choose the appropriate method based on the patient’s bone quality and clinical needs, ensuring optimal stability and integration during hip replacement.
What regulatory approval does the Renewal Acetabular Cup System hold?
The Renewal Acetabular Cup System holds FDA 510(k) clearance under the designation K020145, classified under the Orthopedic Orthopedic Orthopedic advisory committee. This clearance indicates the device is deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for safety and effectiveness.