Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II

K-Number: K221128 · 2022-10-05

ApplicantArthrex, Inc.
Decision Date2022-10-05
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2022-10-05 under approval number K221128. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II?

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II is a medical device that received FDA 510(k) clearance on 2022-10-05. It is manufactured by Arthrex, Inc.. The 510(k) number is K221128.

When was Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II approved by the FDA?

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II received FDA 510(k) clearance on 2022-10-05, under approval number K221128.

What company makes Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II?

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II?

The FDA product code for Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II is MAI.

Other Devices by Arthrex, Inc.

K161060Arthrex iBalance UKA System Vitamin E Tibial Bearing K161782Arthrex Univers Revers Shoulder Prosthesis System K161581Arthrex Synergy RF System K161108Arthrex VaultLock Glenoid K160319FiberTak DR K151527Arthrex Univers Revers CA Heads and Adapters

View all 168 devices →

Related Devices (Code: MAI)

K161174Nanova Interference ScrewNanova Biomaterials, Inc. K160804INTRAFIX(TM) Advance Tibial Fastener SystemMedos International SARL K151342Arthrex SwiveLock AnchorsArthrex, Inc. K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑