Global Modular Replacement System Adapter
510(k) K023692
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023692 | Date20 Mar 2003 | 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- Withdrawn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
- 510(k) Number
- FDA product code
- LWJ
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3360
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Global Modular Replacement System Adapter is a semi-constrained hip prosthesis designed for modular orthopedic applications. It is constructed from metal and polymer materials and is intended for uncemented fixation in total hip arthroplasty procedures. This adapter facilitates modularity within hip replacement systems, enabling customised component attachment without compromising stability or fit.
This device is supplied as a reusable orthopedic implant component and is regulated under FDA 510(k) clearance (K023692) as a Class II medical device under product code LWJ. It is intended for use in orthopedic surgical settings and must be handled and sterilised according to manufacturer guidelines. No specific MRI safety information is provided, and its use is restricted to qualified surgical professionals in accredited facilities.
Other devices from Howmedica Osteonics Corp.
Questions
AI-generated answers, 20 Sep 2026
What types of hip replacement procedures is this adapter designed for, and how does it contribute to modularity in those procedures?
The Global Modular Replacement System Adapter is specifically designed for total hip arthroplasty (THA) procedures where uncemented fixation is used. It enables modularity by allowing surgeons to attach customizable components—such as stems, heads, or liners—without sacrificing stability or fit. This modularity helps tailor the implant to the patient’s anatomy and clinical needs while maintaining secure attachment within the femoral component.
Is this adapter intended for single-use or can it be reused in multiple surgeries? How should it be handled to ensure safety?
The adapter is supplied as a reusable orthopedic implant component, meaning it is intended for multiple surgical uses under strict sterilization protocols. Proper handling and sterilization are critical, as outlined in the manufacturer’s guidelines, to prevent contamination and ensure patient safety. Reuse must only occur in accredited surgical facilities by qualified professionals.
What materials is the adapter made from, and how does this affect its performance in uncemented hip replacements?
The adapter is constructed from metal and polymer materials, which provide the necessary strength and biocompatibility for uncemented fixation. Metal components offer durability and structural integrity, while polymers may contribute to reduced friction and wear in modular interfaces. This combination supports long-term stability and integration with bone in uncemented applications.
Are there any restrictions on where or by whom this device can be used, and what considerations should surgeons keep in mind?
This device is restricted to use by qualified surgical professionals in accredited facilities, as it requires specialized training and sterile conditions. While no specific MRI safety information is provided, its design is not intended for MRI environments. Surgeons should ensure proper preoperative planning, modular component compatibility, and adherence to manufacturer guidelines for optimal outcomes.