Titanium Modular Collared Hip Prosthesis
by Depuy, Inc. 510(k)
Active
510(k) K895035
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK895035 | Date31 Jan 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JDI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3350
- Advisory Committee
- Orthopedic
- FDA Decision
- SN
Overview
AI-generated summary, 1 Oct 2026
The Titanium Modular Collared Hip Prosthesis is a modular femoral implant classified as a Hip Prosthesis (NEC ODEP) under the FDA’s orthopedic device nomenclature. It features a titanium construction with a modular design, allowing customisation of stem length and neck offset, and includes a collared interface to enhance stability and bone ingrowth. The collared design is intended to reduce micromotion at the bone-implant interface, improving long-term fixation. This device is intended for use in primary or revision total hip arthroplasty procedures.
This prosthesis is supplied sterile and intended for single-use in controlled surgical environments. It is designed for use with MRI-compatible imaging systems, though compatibility should be verified with the specific MRI unit in use. The modular components enable intraoperative adjustments to accommodate varying femoral anatomy. Authorised under FDA 510(k) clearance (K895035), it adheres to traditional review standards for orthopedic implants. Storage requires adherence to manufacturer guidelines for sterile packaging integrity.
Other devices from Depuy, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Titanium Modular Collared Hip Prosthesis designed for?
This device is specifically designed for use in primary or revision total hip arthroplasty procedures. Its modular titanium construction, including a collared interface, aims to enhance stability and reduce micromotion at the bone-implant interface, which helps improve long-term fixation. The collared design is intended to promote bone ingrowth, contributing to better integration with the patient’s anatomy.
How is the Titanium Modular Collared Hip Prosthesis supplied and intended for use?
The prosthesis is supplied sterile and is intended for single-use in controlled surgical environments. This ensures optimal sterility and safety during implantation, reducing the risk of infection or contamination. The modular components allow for intraoperative adjustments to accommodate varying femoral anatomy, providing flexibility during surgery.
Can this prosthesis be used with MRI imaging, and what considerations should be taken?
Yes, the Titanium Modular Collared Hip Prosthesis is designed for use with MRI-compatible imaging systems. However, compatibility should always be verified with the specific MRI unit in use, as variations in equipment may affect imaging results. This step ensures accurate diagnostic imaging post-surgery without compromising patient safety.
What are the key features that distinguish this prosthesis from non-modular designs?
The distinguishing features include its modular design, allowing customization of stem length and neck offset to match individual patient anatomy. The collared interface provides enhanced stability by reducing micromotion at the bone-implant junction, which is critical for long-term fixation. This contrasts with non-modular designs, where adjustments cannot be made intraoperatively, potentially limiting fit and stability.
How should the prosthesis be stored to maintain sterility?
Storage must adhere strictly to the manufacturer’s guidelines for preserving the integrity of the sterile packaging. This typically involves keeping the device in its original sealed packaging, away from moisture, extreme temperatures, and direct sunlight. Proper storage ensures the prosthesis remains uncontaminated and ready for surgical use when needed.