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Hitch LactoSorb Suture Anchor

by Arthrotek, Inc.

510(k) K061657

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 NumberK061657 Date25 Jul 2006ClearedStatusActive

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  • Withdrawn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
JDR
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Hitch LactoSorb Suture Anchor is a resorbable implant for soft tissue reattachment. It consists of L-Lactide/Glycolide material preloaded with #2 polyethylene surgical sutures. The device is used in orthopedic procedures to secure soft tissue to bone.

The surgeon inserts the anchor into bone via a pre-drilled hole or by screwing into a tapped pre-drilled hole. It is available in various sizes and is intended for use in shoulder, wrist/hand, elbow, and knee procedures. The device has FDA 510(k) clearance with product code JDR.

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Questions

AI-generated answers, 26 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 Hitch LactoSorb Suture Anchor used for?

    The Hitch LactoSorb Suture Anchor is used to secure soft tissue to bone in orthopedic procedures such as shoulder, wrist/hand, elbow, and knee surgeries, providing resorbable fixation for tissue reattachment.

  • How is the Hitch LactoSorb Suture Anchor supplied and implanted?

    The device is supplied preloaded with #2 polyethylene surgical sutures and is implanted by inserting it into a pre-drilled bone hole or by screwing it into a tapped pre-drilled hole during surgery.

  • Is the Hitch LactoSorb Suture Anchor designed for single use or reuse?

    The Hitch LactoSorb Suture Anchor is a single-use implant intended for one-time implantation; it is not designed for cleaning, sterilization, or reuse after initial use.

  • What sizes and models are available for the Hitch LactoSorb Suture Anchor?

    The device is available in various sizes to accommodate different anatomical sites and surgical needs in shoulder, wrist/hand, elbow, and knee procedures, though specific size dimensions are not detailed in the provided data.

  • How should the Hitch LactoSorb Suture Anchor be stored before use?

    While specific storage conditions are not stated in the device data, as a sterile, resorbable implant, it should be stored in its original packaging under standard medical device conditions to maintain sterility and material integrity until use.