BioScrew Absorbable Interference Screw

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

510(k) Number

K933719 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SN

• EndoPearl

  Class II

  FDA 510(k) K984171 Active Cleared 29 Apr 1999

• Trident Resection Ablator

  Class II

  FDA 510(k) K033748 Active Cleared 15 Dec 2003

• Linvatec 300W Xenon Light Source

  Class II

  FDA 510(k) K031994 Active Cleared 21 Aug 2003

• Cuto(Tm) Tissue Morcellation System

  Class I

  FDA 510(k) K932700 Active Cleared 15 Oct 1993

• El Lightwave Suction Ablator, Model El-2000-S, Lightwave Suction Ablator, Model Ia-2000-S, Lightwave Ablator, Model Ia-

  Class II

  FDA 510(k) K083281 Active Cleared 25 Feb 2009

• Resection Ablator

  Class II

  FDA 510(k) K013369 Active Cleared 4 Apr 2002

See all devices from Linvatec Corp. →

• What types of orthopedic procedures is the BioScrew Absorbable Interference Screw designed to support during bone or tendon healing?

  The BioScrew Absorbable Interference Screw is specifically designed for internal fixation in orthopedic procedures to stabilize bone fragments or tendons. It achieves this through interference compression, providing mechanical support during the healing process. This makes it suitable for applications where secure fixation is needed to maintain alignment while tissues repair.

• Is the BioScrew Absorbable Interference Screw intended for reuse, or is it meant to be used only once?

  The BioScrew Absorbable Interference Screw is classified for single-use applications. This classification aligns with standard sterile medical device protocols to ensure patient safety and device integrity, as reuse could compromise sterility and performance.

• How should the BioScrew Absorbable Interference Screw be stored to maintain its sterility before use?

  The device must be stored and handled according to sterile medical device protocols to preserve its integrity. Since it is supplied sterile, proper storage conditions—such as sealed packaging and protection from contamination—are critical to ensure it remains uncontaminated until use.

• What regulatory pathway was followed for FDA clearance of the BioScrew Absorbable Interference Screw, and what does this mean for its use?

  The BioScrew Absorbable Interference Screw received FDA clearance through a 510(k) submission (K933719), which is a traditional premarket notification process. This clearance indicates that the device was deemed *substantially equivalent* to a legally marketed predicate device for some indications, meaning it meets FDA standards for safety and effectiveness under the specified conditions of use.