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ATL Anchors

by International Life Sciences

510(k) K200503

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

Recall on shared 510(k) K200503; other models may be affected

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 NumberK200503 Date2 Sep 2020ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1556-2026 FDA Class II initiated 6 Feb 2026 on shared 510(k) K200503
    • Ongoing Z-1554-2026 FDA Class II initiated 6 Feb 2026 on shared 510(k) K200503

    Augmentation devices failed bacterial endotoxin testing.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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, 18 Sep 2026

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

ATL Anchors are smooth or threaded metallic bone fixation fasteners for soft tissue, designed to secure tendons, ligaments, or other soft tissue structures to bone. Classified under 21 CFR 888.3040, these anchors provide stable fixation in orthopedic procedures, particularly for ligamentous or tendon repairs requiring durable attachment.

Supplied as a single-use, sterile device, ATL Anchors are intended for in-office or surgical use under aseptic conditions. They are non-degradable and fall under FDA 510(k) clearance (K200503), classified as Class II with Special Controls under product code MBI. Storage and handling must comply with sterile medical device protocols to ensure integrity before use.

Other devices from International Life Sciences

Questions

AI-generated answers, 18 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 types of procedures are ATL Anchors primarily used for, and why are they considered suitable for these applications?

    ATL Anchors are designed for orthopedic procedures where soft tissue—such as tendons or ligaments—needs to be securely attached to bone. They are particularly useful in ligamentous or tendon repairs where durable fixation is required to ensure stability during healing. The smooth or threaded metallic construction provides reliable anchoring, making them ideal for in-office or surgical settings where precise fixation is critical.

  • Are ATL Anchors reusable, and if not, what precautions should be taken during storage to maintain sterility?

    ATL Anchors are intended for single-use only and are supplied in a sterile package. To preserve sterility before use, they must be stored according to standard sterile medical device protocols—typically in a clean, dry environment, away from direct light or moisture, and protected from contamination until the time of use. Always follow manufacturer instructions for handling to prevent compromise of sterility.

  • What distinguishes the threaded version of ATL Anchors from the smooth version, and how might this affect their clinical use?

    The threaded version of ATL Anchors is designed to provide enhanced grip and stability within bone compared to the smooth variant. Threads increase friction and mechanical interlocking, which can be beneficial in procedures requiring deeper or more secure fixation, such as certain ligament repairs. The smooth version may be preferred in cases where minimal tissue trauma or easier insertion is desired, such as in softer bone or delicate repairs.

  • How should I determine the correct size or model of ATL Anchors for a specific patient or procedure?

    The selection of ATL Anchors depends on the anatomical site, bone density, and the specific soft tissue being repaired. While exact sizing details are not provided in the data, the device is classified under 21 CFR 888.3040 for bone fixation, implying availability in standard orthopedic anchor sizes. Consulting preoperative imaging or working closely with the manufacturer’s technical support can help ensure the correct model is chosen for optimal fixation and clinical outcomes.