GEO 1st MTP Joint Arthrodesis Plating System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200108 FDA 510(k)
- FDA Product Code
- HRS 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 First Metatarsal-Phalangeal Joint Arthrodesis Plating System is a surgical orthopedic device classified as a plate for fixation. It is designed to stabilize and fuse the first metatarsal-phalangeal (MTP) joint, addressing conditions such as arthrodesis, osteotomy, nonunion, or revision surgery in the foot.
This system is supplied as a reusable surgical implant and is intended for use in orthopedic procedures. It includes plates and associated instrumentation for precise sizing and placement, adhering to FDA 510(k) clearance under K200108. The device is regulated under the Orthopedic advisory committee and is intended for professional medical use only.
Frequently asked questions
What types of foot conditions is this plating system specifically designed to address in surgical procedures?
This system is designed for stabilizing and fusing the first metatarsal-phalangeal (MTP) joint during arthrodesis (joint fusion), osteotomy (bone cutting/reshaping), nonunion (failed bone healing), or revision surgeries. It is not intended for general foot pain or non-surgical conditions.
Is the GEO 1st MTP Joint Arthrodesis Plating System intended for single-use or can it be reused in multiple procedures?
The device is explicitly described as a reusable surgical implant, meaning it is engineered for sterilization and repeated use in orthopedic procedures. Reuse requires adherence to strict sterilization protocols to maintain safety and performance.
How is the device supplied, and does it include any specialized tools for placement?
The system is supplied as a complete kit, including plates for fixation and associated instrumentation designed for precise sizing and placement of the implant. The tools are tailored to the specific anatomical requirements of the first MTP joint, ensuring accurate alignment during surgery.
What regulatory pathway was followed for FDA clearance of this device, and which advisory committee reviewed it?
The device was cleared via a Traditional 510(k) pathway under the product code HRS, with a decision of Substantially Equivalent (SESE). It was reviewed by the Orthopedic (OR) Advisory Committee and filed by Gramercy Extremity Orthopedics, LLC, in Richardson, TX, as part of submission K200108.
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 1st MTP Joint Arthrodesis Plating System (K200108 ... - fda ..., GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System, PDF Operative Technique - gramercyortho.com, GEO FirstFUSE 1st MTP Joint Arthrodesis... (K210534) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200108 | Class II | Active |
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Manufacturer
- Manufacturer
- Gramercy Extremity Orthopedics Llc
- FDA Applicant
- Gramercy Extremity Orthopedics, LLC
Sources (1)
- FDA 510(k) K200108 24 fields · synced Sep 19, 2026