Speedlock Knotless Fixation Device, 3mm Drill, 3MM+ Drill, Pathfinder Obturator & Sharp Tipped Obturator, Low Profile Dr

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

510(k) Number

K130196 ↗

FDA Product Code

MBI

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What types of orthopedic procedures is the SpeedLock Knotless Fixation Device primarily used for?

  The SpeedLock Knotless Fixation Device is designed for soft-tissue-to-bone fixation in orthopedic procedures like Bankart repairs and other soft tissue stabilization techniques. It uses a knotless system to securely anchor tissues, reducing the need for traditional suturing methods.

• Is the SpeedLock Knotless Fixation Device intended for reuse, or is it meant to be used only once?

  The SpeedLock Knotless Fixation Device is explicitly supplied sterile and intended for single-use only. Reusing it could compromise sterility and compromise patient safety, so it must be discarded after one procedure.

• What components are included in the SpeedLock Knotless Fixation Device kit, and how do they function?

  The kit includes a 3mm drill, a 3mm+ drill, a Pathfinder obturator, and a sharp-tipped obturator, all designed to create precise anchor points in bone for soft tissue fixation. The drills prepare the site, while the obturators assist in placing the fixation device without damaging surrounding tissue.

• How should the SpeedLock Knotless Fixation Device be stored to ensure it remains sterile and functional?

  Since the device is sterile, it must be stored and handled following sterile instrument protocols to maintain its integrity. This includes keeping it in its original packaging, away from contamination, and adhering to manufacturer guidelines to prevent damage or compromise of sterility before use.

• What regulatory pathway was followed for FDA clearance of this device, and what class does it fall under?

  The SpeedLock Knotless Fixation Device was cleared via an FDA 510(k) submission (K130196) under the Orthopedic (OR) advisory committee, classified as a Class II medical device. The clearance was granted as substantially equivalent to a predicate device, adhering to orthopedic fixation standards.