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AnchorLok RL Soft Tissue Anchor System

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K964786

Overview

The AnchorLok RL Soft Tissue Anchor System is a Fastener, Fixation, Nondegradable, Soft Tissue device, classified under product code MBI. It is designed for securing soft tissue during surgical repairs, providing stable fixation for reconstructive procedures in orthopedic applications. The system is intended for use in procedures such as shoulder instability repairs, rotator cuff reconstructions, and capsular shifts, where reliable tissue attachment is critical. Its non-degradable construction ensures long-term stability in the repaired area.

This device is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance (K964786) under traditional review. It is intended for use in orthopedic surgical settings, where it is implanted to anchor soft tissue to bone or other structures. The system is regulated as a Class II medical device under special controls, ensuring compliance with stringent manufacturing and performance standards. Proper storage and handling are required to maintain sterility and functionality prior to use.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964786 Date6 Feb 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the AnchorLok RL Soft Tissue Anchor System used for?

    The AnchorLok RL Soft Tissue Anchor System is designed to secure soft tissue during surgical repairs in orthopedic procedures. It provides stable fixation for critical reconstructions such as shoulder instability repairs, rotator cuff reconstructions, and capsular shifts, ensuring reliable attachment of soft tissue to bone or other structures.

  • Is the AnchorLok RL Soft Tissue Anchor System reusable or single-use?

    The AnchorLok RL Soft Tissue Anchor System is intended for single-use only. This design choice ensures sterility and safety for each patient, reducing the risk of contamination or degradation between uses.

  • How is the AnchorLok RL Soft Tissue Anchor System supplied?

    The system is supplied sterile, meeting regulatory standards for medical devices. Proper storage and handling instructions must be followed to maintain its sterility and functionality before use in surgical settings.

  • What type of materials is the AnchorLok RL Soft Tissue Anchor System made from?

    The AnchorLok RL Soft Tissue Anchor System is constructed from non-degradable materials, which ensures long-term stability in the repaired area. This design choice is particularly beneficial for procedures requiring durable fixation over extended periods.

  • What regulatory approval does the AnchorLok RL Soft Tissue Anchor System have?

    The AnchorLok RL Soft Tissue Anchor System holds FDA 510(k) clearance under the reference number K964786. It is classified as a Class II medical device under special controls, adhering to stringent manufacturing and performance standards.