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M-ARS ACL: Anatomic Ribbon Surgery System

by Medacta International S.A.

510(k) K171640

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 NumberK171640 Date23 Oct 2017ClearedStatusActive

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  • Withdrawn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
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 M-ARS ACL: Anatomic Ribbon Surgery System is an implantable extra cortical suspension device used for anterior cruciate ligament reconstruction. It is designed to guarantee graft fixation on the tibial side during ACL reconstruction following the M-ARS ACL technique. This system rediscovers the natural anatomy of the ACL, potentially offering more natural stress distribution, improved healing with reduced risk of necrosis, and more precise reconstruction of native ACL bundle kinematics.

The device is supplied as part of the M-ARS ACL reconstruction technique and is used in orthopedic settings. It is intended for single-use in ACL reconstruction procedures. The system has received FDA 510(k) clearance with the product code MBI and was cleared on October 23, 2017, as substantially equivalent to predicate devices for the reconstructive treatment of ruptured anterior cruciate ligaments.

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Questions

AI-generated answers, 22 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 M-ARS ACL: Anatomic Ribbon Surgery System used for?

    The M-ARS ACL: Anatomic Ribbon Surgery System is an implantable extra cortical suspension device specifically designed for anterior cruciate ligament reconstruction. It guarantees graft fixation on the tibial side during ACL reconstruction following the M-ARS ACL technique.

  • How is the M-ARS ACL: Anatomic Ribbon Surgery System supplied?

    The device is supplied as part of the M-ARS ACL reconstruction technique and is intended for single-use in ACL reconstruction procedures. It is used in orthopedic settings to help reconstruct the natural anatomy of the ACL.

  • What are the benefits of using the M-ARS ACL: Anatomic Ribbon Surgery System?

    This system rediscovers the natural anatomy of the ACL, potentially offering more natural stress distribution, improved healing with reduced risk of necrosis, and more precise reconstruction of native ACL bundle kinematics.

  • What is the regulatory status of the M-ARS ACL: Anatomic Ribbon Surgery System?

    The system has received FDA 510(k) clearance with the product code MBI and was cleared on October 23, 2017, as substantially equivalent to predicate devices for the reconstructive treatment of ruptured anterior cruciate ligaments.