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Ligafix Interference Screw

by Sciences For Bio Materials

510(k) K061262

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 · Special NumberK061262 Date5 Jul 2006ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

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

The Ligafix Interference Screw is a cannulated, resorbable interference bone screw used in anterior cruciate ligament (ACL) reconstruction to provide mechanical interference fixation of grafts within the bone. It is indicated for use in ACL reconstruction to secure grafts via interference fixation.

The device is supplied sterile and intended for single-use. It is manufactured by Sciences For Bio Materials and has received FDA 510(k) clearance under K061262. The product code is HWC, and it falls under the Orthopedic advisory committee review.

Other devices from Sciences For Bio Materials

Questions

AI-generated answers, 26 Sep 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 Ligafix Interference Screw used for?

    The Ligafix Interference Screw is used in anterior cruciate ligament (ACL) reconstruction to provide mechanical interference fixation of grafts within the bone, securing the graft in tibial or femoral tunnels during healing.

  • Is the Ligafix Interference Screw sterile and single-use?

    Yes, the Ligafix Interference Screw is supplied sterile and intended for single-use only, as stated in the device description, to ensure patient safety and prevent cross-contamination.

  • What regulatory pathway was used for the Ligafix Interference Screw?

    The Ligafix Interference Screw received FDA 510(k) clearance under submission number K061262, indicating it was found substantially equivalent to a legally marketed predicate device.

  • Who manufactures the Ligafix Interference Screw and where is it from?

    The Ligafix Interference Screw is manufactured by Sciences For Bio Materials, located in Lourdes, France, as indicated by the address and applicant details in the device data.