Memograph Staple, Warm System
by Biomedical Ent., Inc. 510(k)
Active
510(k) K993714
Overview
The Memograph Staple, Warm System is a Staple, Fixation, Bone (21 CFR 888.3030, Product Code JDR) designed for orthopedic fixation. It employs a warm, malleable staple material to secure bone fragments, providing stable internal fixation during surgical procedures.
This system is intended for single-use in orthopedic settings and requires no sterilisation beyond manufacturer-provided packaging. The staples are supplied pre-sterilised and must be stored according to the manufacturer’s instructions to maintain integrity. Authorised under FDA 510(k) clearance (K993714), it adheres to traditional review standards and is classified as a Class II medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993714 | Date25 Feb 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- JDR
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Biomedical Ent., Inc.
Questions
What types of orthopedic procedures is the Memograph Staple, Warm System intended for, and how does its warm, malleable design benefit the surgeon?
The Memograph Staple, Warm System is designed specifically for orthopedic fixation to secure bone fragments during surgical procedures. Its warm, malleable staple material allows for greater adaptability to the bone surface, providing stable internal fixation. This feature can help reduce the risk of displacement and improve healing outcomes by conforming closely to irregular bone fragments.
Is the Memograph Staple, Warm System reusable, or is it meant for single-use only? What does this mean for my operating room workflow?
The Memograph Staple, Warm System is explicitly designed for single-use only. This means each staple is pre-sterilized by the manufacturer and intended to be used once per patient. Since no additional sterilization is required, it simplifies workflow by eliminating the need for reprocessing, reducing contamination risks, and ensuring consistent performance.
How should I store the Memograph Staple, Warm System to ensure it remains effective and sterile until use?
The staples must be stored according to the manufacturer’s instructions provided with the packaging. Since they are pre-sterilized, proper storage ensures sterility and integrity until use. This likely involves keeping them in their sealed, unopened packaging in a clean, dry environment away from extreme temperatures or direct sunlight to prevent degradation of the malleable material.
What does the FDA’s 510(k) clearance (K993714) mean for the Memograph Staple, Warm System, and how does it affect its use in clinical settings?
The FDA’s 510(k) clearance (K993714) confirms that the Memograph Staple, Warm System has been determined to be substantially equivalent to a legally marketed predicate device under traditional review standards. This means it meets FDA safety and effectiveness requirements for its intended use in orthopedic fixation. Clinically, this clearance assures that the device adheres to regulatory standards, but it does not imply any specific clinical indication—only that it complies with FDA guidelines for Class II medical devices.