Bioabsorbable Bankart Tack

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K973849 ↗

FDA Product Code

MAI

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What is the primary clinical purpose of the Bioabsorbable Bankart Tack and how does it differ from traditional fixation methods in shoulder surgery?

  The Bioabsorbable Bankart Tack is specifically designed to stabilize labral or capsular tissues in shoulder joints, particularly for cases involving Bankart lesions. Unlike traditional fixation methods that rely on permanent implants, this device provides temporary fixation that gradually dissolves over time, eliminating the need for removal surgery. Its biodegradable nature reduces long-term complications associated with retained hardware while maintaining stability during the critical healing phase.

• Is the Bioabsorbable Bankart Tack intended for reuse in multiple surgical procedures, or is it strictly single-use?

  The device is explicitly intended for single-use in surgical settings. This is standard practice for biodegradable fixation devices to ensure sterility and prevent cross-contamination between patients, as well as to maintain the integrity of the material during the critical healing period.

• How should the Bioabsorbable Bankart Tack be stored to preserve its sterility and functionality before use?

  The device is supplied sterile, but specific storage instructions are not detailed in the provided data. Typically, biodegradable orthopedic fixation devices like this should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s enclosed instructions for optimal shelf life and sterility, as improper storage could compromise the material’s integrity or sterility.

• What regulatory pathway was followed for FDA clearance of the Bioabsorbable Bankart Tack, and what does this imply for its safety and equivalence?

  The device received FDA clearance through a Traditional 510(k) process, which demonstrates that it is *substantially equivalent* to a legally marketed predicate device. This pathway ensures compliance with FDA regulations for Class II orthopedic fixation devices (as outlined in 28 CFR 888.3030) and confirms that its design, performance, and safety meet established standards for temporary soft tissue fixation in shoulder surgeries.