Identifiers
- 510(k) Number
- K182212 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 Geo Staple System is a surgical staple fixation device classified as an Orthopedic Staple (Product Code: JDR) under FDA nomenclature. It delivers controlled force to deploy symmetric and asymmetric, barbed or smooth Nitinol staples for internal fixation of small bones, including phalanges and metatarsals. The system is designed to provide secure stabilization in orthopedic procedures where traditional wiring or plating may be less practical. Staples are available in varying widths and lengths to accommodate different anatomical sites and clinical requirements.
The Geo Staple System is supplied as a sterile, single-use device, ensuring compliance with surgical sterility protocols. It is intended for use in operating rooms by trained orthopedic surgeons and is compatible with standard imaging modalities, including MRI, as no metallic components interfere with scans. The system is authorized under FDA 510(k) clearance (K182212) and is distributed in sterile packaging to maintain integrity until use. Storage should follow manufacturer guidelines to preserve sterility and functionality.
Frequently asked questions
What is the Geo Staple System used for in orthopedic surgery?
The Geo Staple System is designed for internal fixation of small bones, such as phalanges and metatarsals, where traditional wiring or plating may be less practical. It uses controlled force to deploy symmetric or asymmetric, barbed or smooth Nitinol staples, providing secure stabilization during surgical procedures. This approach is particularly useful in cases requiring minimal hardware interference while ensuring strong fixation.
How is the Geo Staple System supplied, and what does this mean for surgical use?
The Geo Staple System is supplied as a sterile, single-use device, packaged to maintain integrity until use. This ensures compliance with surgical sterility protocols, reducing the risk of contamination and cross-infection. Single-use also eliminates the need for reprocessing, simplifying workflow and ensuring consistent performance for each procedure.
Are the staples in the Geo Staple System compatible with MRI imaging?
Yes, the Geo Staple System is designed with Nitinol staples that do not contain metallic components interfering with MRI scans. This compatibility allows for post-operative imaging without the need for removal of fixation hardware, enabling comprehensive follow-up assessments in patients who require MRI evaluations.
What sizes and types of staples are available in the Geo Staple System?
The Geo Staple System offers staples in varying widths and lengths to accommodate different anatomical sites and clinical requirements. These include symmetric and asymmetric designs, as well as barbed or smooth variants, ensuring versatility for procedures involving small bones. The specific dimensions and configurations are tailored to optimize fixation stability while minimizing tissue trauma.
How should the Geo Staple System be stored to maintain sterility and functionality?
The Geo Staple System should be stored according to the manufacturer’s guidelines to preserve sterility and functionality. This typically involves keeping the sterile packaging intact in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the device remains ready for use when needed, maintaining its performance and compliance with surgical standards.
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: GEO Landing Page - Gramercy Extremity Orthopedics, GEO Staple System by Gramercy Extremity Orthopedics LLC, PDF Gramercy Extremity Orthopedics, Inc., GRAMERCY EXTREMITY ORTHOPEDICS LLC 14110100 GEO Staple System, GRAMERCY EXTREMITY ORTHOPEDICS LLC 70140001 GEO Staple System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182212 | Class II | Active |
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Manufacturer
- Manufacturer
- Gramercy Extremity Orthopedics Llc
- FDA Applicant
- Gramercy Extremity Orthopedics, LLC
Sources (1)
- FDA 510(k) K182212 24 fields · synced Oct 1, 2026