EIS Dynamic Memory Staples System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K991962 FDA 510(k)
- FDA Product Code
- JDR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EIS Dynamic Memory Staples System is an orthopedic device designed for the fixation of fractures by compressing two bones together. It is specifically indicated for use after corrective osteotomy of the big toe, interphalangeal fusion, fractures of the scaphoid, or small trauma injuries. The system utilizes dynamic memory staples to provide stable bone compression during healing.
The device is supplied as a sterile, single-use system and is intended for surgical implantation in clinical settings. It is cleared under FDA 510(k) regulations as a Class II orthopedic device with product code JDR. Storage should follow standard medical device protocols for sterile implants, and MRI safety conditions are not specified in the available data.
Frequently asked questions
What clinical situations is the EIS Dynamic Memory Staples System indicated for?
The system is indicated for fixation after corrective osteotomy of the big toe, interphalangeal joint fusion, scaphoid fractures, and other small trauma injuries where stable bone compression is needed to promote healing.
How is the device supplied and what are the sterility considerations?
It is supplied as a sterile, single‑use package intended for implantation in a clinical setting. Because it is pre‑sterilized, it must be opened only in a controlled environment and used immediately; any remaining components must be discarded to maintain sterility.
Can the staples be reused for multiple patients?
No. The EIS Dynamic Memory Staples System is designed for single‑use only. Reusing the device could compromise sterility and the mechanical integrity of the memory staples, increasing the risk of infection or fixation failure.
What storage requirements apply to this orthopedic implant?
The system should be stored according to standard medical device protocols for sterile implants, typically in a clean, dry area with temperature and humidity controls that prevent moisture buildup and preserve the package integrity until the point of use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EIS DYNAMIC MEMORY STAPLES SYSTEM (K991962) — FDA 510(k) | Innolitics, K991962 FDA 510 (k) - EIS DYNAMIC MEMORY STAPLES SYSTEM, Groupe Lepine FDA 510 (k) Products (1999-2000), GROUPE LEPINE FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991962 | Class II | Active |
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Manufacturer
- Manufacturer
- Groupe Lepine
Sources (1)
- FDA 510(k) K991962 24 fields · synced Sep 26, 2026