Extremity Medical Suture Anchor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K083151 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)
The Extremity Medical Suture Anchor is a surgical device classified as a Suture Anchor (Product Code: MBI) under FDA nomenclature. It is designed for the fixation of suture and/or soft tissue to bone, providing secure attachment in orthopedic procedures. This device is engineered to enhance stability during repairs in specific anatomical regions, including the shoulder, foot/ankle, knee, hand/wrist, and elbow. Its primary function is to facilitate tissue-to-bone integration, aiding in the restoration of anatomical continuity and functional stability.
The device is supplied as a single-use orthopedic implant and is intended for use in surgical settings such as operating rooms. It is regulated under the FDA 510(k) clearance (K083151) and falls under the Orthopedic Advisory Committee’s review. No third-party certification is indicated, and its sterility and MRI safety are not specified in the available data. The device is available in various sizes tailored for different anatomical applications, though exact dimensions are not detailed in the provided specifications.
Frequently asked questions
What is the primary use of the Extremity Medical Suture Anchor?
The Extremity Medical Suture Anchor is designed to fixate suture and/or soft tissue to bone during orthopedic procedures. It ensures stable attachment in specific anatomical regions—such as the shoulder, foot/ankle, knee, hand/wrist, and elbow—to restore anatomical continuity and functional stability. This is particularly useful in surgeries where secure tissue-to-bone integration is critical.
Is the Extremity Medical Suture Anchor intended for single-use or reusable applications?
The device is explicitly supplied as a single-use orthopedic implant. This classification aligns with surgical best practices for minimizing infection risks and ensuring sterility, as reusable implants require rigorous cleaning and sterilization processes that may compromise material integrity or introduce contamination.
What anatomical regions is this suture anchor optimized for?
The Extremity Medical Suture Anchor is engineered for use in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Its design accommodates the biomechanical demands of these regions, providing tailored fixation solutions for soft tissue repairs where stability is essential to postoperative recovery and function.
Are there different sizes available for this suture anchor?
Yes, the device is available in various sizes tailored to different anatomical applications. While exact dimensions are not specified in the provided data, the range of sizes ensures compatibility with diverse patient anatomies and surgical requirements, allowing clinicians to select the appropriate anchor for their procedure.
How is the Extremity Medical Suture Anchor regulated by the FDA?
The device has received FDA 510(k) clearance under the classification of a Suture Anchor (Product Code: MBI) and was reviewed by the Orthopedic Advisory Committee. The clearance type is Traditional, and it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness.
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: Extremity Medical, EXTREMITY MEDICAL SUTURE ANCHOR by EXTREMITY MEDICAL LLC | FDA 510(k ..., Extremity Medical Suture Anchor (K150166) — FDA 510 (k) | Innolitics, K150166 FDA 510 (k) - Extremity Medical Suture Anchor
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083151 | Class II | Active |
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Manufacturer
- Manufacturer
- Extremity Medical, LLC
Sources (1)
- FDA 510(k) K083151 24 fields · synced Oct 1, 2026