FDA 510(k)

Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants

K-Number: K221468 · 2023-02-14

Decision Date2023-02-14

Product CodeMAI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants is a medical device manufactured by Acuitive Technologies, Inc.. It received FDA 510(k) clearance on 2023-02-14 under approval number K221468. 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 Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants?

Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants is a medical device that received FDA 510(k) clearance on 2023-02-14. It is manufactured by Acuitive Technologies, Inc.. The 510(k) number is K221468.

When was Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants approved by the FDA?

Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants received FDA 510(k) clearance on 2023-02-14, under approval number K221468.

What company makes Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants?

Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants is manufactured by Acuitive Technologies, Inc..

What is the FDA product code for Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants?

The FDA product code for Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants is MAI.

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Related PubMed Literature

PMID: 41947919 Analysis of Trends in FDA-Recalled Hip Arthroplasty Devices: A Retrospective Review. JB & JS open access (2026) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 41453025 Characterization and Time-delay in Issuing High-risk Recalls of Orthopaedic Devices From 2002 to 2023. The Journal of the American Academy of Orthopaedic Surgeons (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Acuitive Technologies, Inc.

K210239CITRESPLINE and CITRELOCK ACL Implants K203334The Citrefix Knotless Suture Anchor K220833Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL K232592CITRELOCK® DUO K240450Citrepore

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

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