Bioscrew Absorbable Interference Screw

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

510(k) Number

K960652 ↗

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 is the Bioscrew Absorbable Interference Screw used for?

  The Bioscrew Absorbable Interference Screw is designed for bone fixation and provides stabilization for soft tissue grafts in orthopedic procedures. It is implanted to help secure tissues during recovery.

• Is the Bioscrew reusable or single-use?

  The Bioscrew is supplied as a single-use implant only. It should not be reused on multiple patients as this could compromise sterility and device performance.

• What sizes are available for the Bioscrew Absorbable Interference Screw?

  The Bioscrew is available in various sizes as specified by the manufacturer. The specific size options would be determined based on the patient's anatomy and the requirements of the surgical procedure.

• Is the Bioscrew MRI safe?

  No, the Bioscrew Absorbable Interference Screw is not MRI safe. Patients with this implant should avoid MRI scans as the device may interfere with the imaging process or pose safety risks.