Identifiers
- 510(k) Number
- K120573 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medart 620 is a suture anchor designed for use in orthopaedic and plastic surgery procedures. It provides secure fixation of soft tissue or tendon to bone, utilising a self-drilling and self-tapping mechanism to minimise trauma during implantation.
This device is supplied as a sterile, single-use product and is intended for use in surgical settings. It is classified under product code GEX and has received FDA 510(k) clearance as substantially equivalent under the Special 510(k) Review Program. Storage and handling must comply with standard surgical instrument protocols to maintain sterility and functionality.
Frequently asked questions
What types of surgical procedures is the Medart 620 suture anchor intended for, and how does it work during implantation?
The Medart 620 suture anchor is designed specifically for orthopaedic and plastic surgery procedures where secure fixation of soft tissue or tendon to bone is required. It uses a self-drilling and self-tapping mechanism, which reduces trauma during implantation by eliminating the need for separate drilling or tapping steps. This feature simplifies the surgical process while ensuring stable attachment.
Is the Medart 620 suture anchor reusable, or is it meant for single-use only? How should it be stored to maintain sterility?
The Medart 620 is explicitly supplied as a sterile, single-use product, meaning it should not be reused after a single surgical procedure. To preserve sterility and functionality, storage must follow standard surgical instrument protocols, typically involving sterile packaging and adherence to manufacturer guidelines for handling and shelf life.
What regulatory pathway was followed for FDA clearance of the Medart 620, and what does this mean for its use in clinical settings?
The Medart 620 received FDA 510(k) clearance under the Special 510(k) Review Program, with a decision classification of substantially equivalent (SESE). This means the device was determined to be comparable to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness. Clinically, this clearance indicates the device has undergone review by the FDA for compliance with applicable regulations before being authorized for use.
Are there different sizes or models of the Medart 620 suture anchor available, and if so, how would a clinician determine the appropriate size for a procedure?
The provided data does not specify varying sizes or models for the Medart 620 suture anchor. Typically, suture anchors come in different sizes to accommodate varying bone diameters or tissue thicknesses, so clinicians would rely on the manufacturer’s sizing guidelines or surgical planning to select the appropriate anchor for their procedure. For precise details, consulting the product documentation or contacting Medart A/S would be advisable.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120573 | Class II | Active |
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Manufacturer
- Manufacturer
- Medart A/S
Sources (1)
- FDA 510(k) K120573 24 fields · synced Sep 19, 2026