Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202259 FDA 510(k)
- FDA Product Code
- MBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
These devices are orthopedic fixation instruments designed for ligament and tendon repair procedures. They include a range of tools for securing soft tissue structures, such as tendons and ligaments, during surgical interventions. The product line encompasses both manual and powered instruments tailored for precision and stability in orthopedic reconstructions.
The instruments are supplied sterile for single-use and are intended for use in operating room settings. They comply with FDA 510(k) clearance under the Traditional pathway and meet the requirements of the Medical Device Directive (MDD). Each model is engineered for specific applications, with sizes and configurations detailed in the manufacturer’s specifications. No MRI safety information is provided, and devices must be handled according to sterile surgical protocols.
Frequently asked questions
Are these instruments reusable or designed for single-use only, and what does that mean for my surgical workflow?
These instruments are sterile, single-use only, meaning each device is intended for one surgical procedure and must not be reused or reprocessed. This design ensures consistent performance and reduces the risk of cross-contamination in the operating room. Since they’re pre-sterilized, you can open the packaging immediately before use, streamlining your workflow without the need for sterilization between cases.
How do I know which model is best suited for my specific ligament or tendon repair procedure?
The Parcus GFS series (GFS II, Mini, Naked, Ultimate, BTB, Ultimate Hip) and Actiflip variants (Naked, Cinch, Whip) are engineered for different applications. For example, the GFS Ultimate Hip is tailored for hip reconstructions, while the Actiflip Whip may offer enhanced flexibility for specific tendon repairs. The ATLAS and Synd-EZ Ti models are designed for precision in ligament fixation. Always refer to the manufacturer’s specifications or consult with your surgical team to match the model to your procedure’s requirements.
What storage conditions should I follow to maintain the sterility and functionality of these instruments?
These instruments are sterile upon packaging and should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Keep them in their original, sealed packaging until ready for use to preserve sterility. Avoid exposing them to moisture or contaminants, as this could compromise their integrity. Once opened, use immediately in the operating room to prevent contamination.
Are these instruments compatible with MRI imaging, and if not, what precautions should I take?
The manufacturer does not provide MRI safety information for these devices, meaning their compatibility with MRI is not confirmed. If MRI is required post-surgery, remove these instruments from the patient’s body before imaging. Always follow sterile surgical protocols and consult your hospital’s MRI safety protocols to ensure patient safety.
How do I confirm the regulatory compliance of these instruments before purchasing?
These instruments are FDA 510(k)-cleared under the Traditional pathway (K202259) and comply with the Medical Device Directive (MDD). The clearance indicates they meet U.S. regulatory standards for orthopedic fixation instruments, while the MDD ensures compliance with EU requirements. Always verify the specific regulatory status in your region and confirm the product code (MBI) aligns with your local classification before procurement.
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: Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS ..., Parcus Gfs Ii And Gfs Mini, Gfs Naked, Gfs Ultimate, Gfs Btb, Atlas ..., 510 (k) Premarket Notification - Food and Drug Administration
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K202259 | Class II | Active |
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Manufacturer
- Manufacturer
- Parcus Medical Llc
- FDA Applicant
- Parcus Medical, LLC
Sources (2)
- FDA 510(k) K202259 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 18, 2026