Identifiers
- 510(k) Number
- K252081 FDA 510(k)
- FDA Product Code
- HTN 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 SportLinc Syndesmosis Device is a surgical implant classified as a syndesmosis fixation device (HTN product code) under FDA orthopedic nomenclature. It is designed to stabilize the syndesmotic ligaments of the ankle joint following traumatic injury, providing mechanical support to restore and maintain ankle alignment during the healing process.
This device is supplied sterile and intended for single-use only. It consists of an ultra-high-molecular-weight polyethylene suture tensioned between two low-profile titanium alloy buttons, offering flexibility for use with or without additional plate fixation. The device is regulated under FDA 510(k) clearance (K252081) as substantially equivalent to a predicate device, with no explicit MRI safety labeling provided in the data. Storage and handling must comply with sterile surgical implant protocols.
Frequently asked questions
What is the SportLinc Syndesmosis Device used for in clinical practice?
The SportLinc Syndesmosis Device is designed to stabilize the syndesmotic ligaments in the ankle joint after traumatic injury. It provides mechanical support to help restore and maintain proper ankle alignment while the ligaments heal, ensuring stability during the recovery process.
Is the SportLinc Syndesmosis Device intended for reuse or single-use?
The device is explicitly labeled for single-use only, meaning it should not be reused after a single surgical procedure. This aligns with standard sterile surgical implant protocols to ensure patient safety and sterility.
What materials are used in the SportLinc Syndesmosis Device, and how is it constructed?
The device consists of two low-profile titanium alloy buttons connected by an ultra-high-molecular-weight polyethylene suture. This design allows flexibility in use, whether with or without additional plate fixation, while maintaining stability for syndesmosis repair.
How should the SportLinc Syndesmosis Device be stored and handled?
Since the device is supplied sterile, it must be stored and handled according to sterile surgical implant protocols. This ensures its integrity and sterility until use in the operating room, preventing contamination or damage.
What regulatory pathway was followed for the SportLinc Syndesmosis Device, and what does that mean for its use?
The device underwent FDA 510(k) clearance (K252081) and was determined to be substantially equivalent to a predicate device under the orthopedic product code HTN. This means it meets FDA standards for safety and effectiveness as a syndesmosis fixation device, though no explicit MRI safety labeling is provided.
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: Lincotek secures FDA 510(k) clearance for SportLinc™, Lincotek Secures FDA 510 (k) Clearance for SportLinc, Lincotek secures FDA 510(k) clearance for SportLinc™
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252081 | Class II | Active |
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Manufacturer
- Manufacturer
- Lincotek Medical
Sources (1)
- FDA 510(k) K252081 24 fields · synced Sep 20, 2026