S-ROM Hip System - Locking Plug
by Johnson & Johnson Professionals, Inc. 510(k)
Active
510(k) K963206
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK963206 | Date17 Oct 1996 | 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- Withdrawn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
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The S-ROM Hip System - Locking Plug is a component for total hip replacement systems. It functions as a mechanical locking mechanism to secure the shell/liner assembly. The device features a cylindrical body with an external lip and a head with external serrations or barbs, and includes internal threading that allows attachment to an insertion tool.
It is supplied as part of the S-ROM Hip System and is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to various conditions. The device is reusable and requires sterilization prior to use. It is not MRI safe unless specifically tested and labeled as such. Storage should follow manufacturer guidelines for reusable orthopedic components. Authorization is based on FDA 510(k) clearance under K963206.
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Questions
AI-generated answers, 27 Sep 2026
What is the S-ROM Hip System Locking Plug used for?
The S-ROM Hip System Locking Plug functions as a mechanical locking mechanism to secure the shell/liner assembly in total hip replacement systems, ensuring stability of the prosthetic joint during use.
Is the S-ROM Hip System Locking Plug reusable or single-use?
The device is reusable and must be sterilized prior to each use, as specified in the manufacturer guidelines for reusable orthopedic components, to maintain safety and functionality across multiple procedures.
How is the S-ROM Hip System Locking Plug supplied and what are its key features?
It is supplied as part of the S-ROM Hip System and features a cylindrical body with an external lip, a head with external serrations or barbs, and internal threading that allows attachment to an insertion tool for secure placement during surgery.
What storage and handling requirements apply to the S-ROM Hip System Locking Plug?
Storage should follow manufacturer guidelines for reusable orthopedic components, and the device is not MRI safe unless specifically tested and labeled as such, requiring careful handling to preserve integrity and safety.