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BioScrew Absorbable Interference Screw

by Linvatec Corp. 4 variants

510(k) K960940

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960940 Date15 Aug 1996ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BioScrew Absorbable Interference Screw is a resorbable orthopedic fixation device classified as an interference screw. Constructed from Poly (L-Lactic Acid), it is designed to secure soft tissue grafts during ligament reconstruction procedures, such as ACL or PCL repair, by providing stable fixation while gradually degrading over time.

Supplied as a single-use device, the BioScrew Absorbable Interference Screw is intended for tibial fixation in orthopedic settings. It is cleared under FDA 510(k) with the reference number K960940, falling under the Orthopedic advisory committee classification. The device is not MRI-safe and must be stored according to manufacturer guidelines to maintain sterility and integrity prior to use.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BioScrew Absorbable Interference Screw used for?

    The BioScrew Absorbable Interference Screw is designed specifically for securing soft tissue grafts during ligament reconstruction procedures, such as anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) repairs. Its purpose is to provide stable fixation while gradually degrading over time, ensuring the graft remains securely positioned as it integrates with the surrounding bone.

  • How is the BioScrew Absorbable Interference Screw supplied?

    This device is supplied as a single-use item, meaning each screw is intended for one surgical procedure only. This ensures sterility and prevents cross-contamination, which is critical in orthopedic settings where infection control is paramount.

  • Is the BioScrew Absorbable Interference Screw sterile?

    Yes, the BioScrew Absorbable Interference Screw is supplied in a sterile condition. Proper storage according to the manufacturer’s guidelines is essential to maintain its sterility and structural integrity before use, as contamination or damage could compromise its performance during surgery.

  • What material is the BioScrew Absorbable Interference Screw made from?

    The screw is constructed from Poly (L-Lactic Acid), a biodegradable polymer that allows the device to gradually dissolve and be absorbed by the body over time. This resorbable design eliminates the need for a secondary removal procedure after the graft has healed.

  • Can the BioScrew Absorbable Interference Screw be used in MRI scans?

    No, the BioScrew Absorbable Interference Screw is not MRI-safe. If MRI imaging is required post-surgery, clinicians must ensure the screw is accounted for and avoid imaging protocols that could cause interference or harm due to its non-MRI-compatible composition.