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Arthrex Staples

by Arthrex, Inc.

510(k) K943492

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)SN Traditional NumberK943492 Date1 Feb 1995DecidedStatusActive

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  • Withdrawn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
SN

Overview

AI-generated summary, 1 Oct 2026

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

The Arthrex Staples are orthopedic fixation devices designed for internal stabilization of bone fractures or osteotomies. These staples provide compressive force to maintain alignment and promote proper healing, particularly in small-joint and limb procedures. Their cannulated design allows for precise placement with minimal soft tissue disruption, enhancing surgical efficiency. The system includes graduated guidewires and cannulated drills to ensure accurate positioning and leg-length restoration.

Supplied as a reusable surgical instrument set, the Arthrex Staples are intended for use in orthopedic procedures under sterile conditions. They are classified under product code JDR and were cleared by the FDA via a 510(k) submission (K943492) under the Traditional pathway, with a decision date of February 1, 1995. No MRI safety or single-use specifications are noted in the regulatory data. Storage and handling follow standard orthopedic instrument protocols to maintain sterility and functionality.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What are the Arthrex Staples designed for in orthopedic surgery?

    The Arthrex Staples are orthopedic fixation devices specifically engineered to stabilize bone fractures or osteotomies internally. Their cannulated design allows for accurate placement through bone tunnels, minimizing soft tissue disruption and ensuring proper alignment for healing. This is particularly useful in procedures involving small joints or limbs, where precise leg-length restoration is critical.

  • How are the Arthrex Staples supplied, and what does this mean for surgical use?

    The Arthrex Staples are supplied as a reusable surgical instrument set. This means the staples, along with their accompanying tools like graduated guidewires and cannulated drills, are intended for repeated use in sterile surgical environments. Reusability requires strict adherence to manufacturer protocols for cleaning, sterilization, and storage to maintain functionality and prevent contamination.

  • Are the Arthrex Staples single-use or reusable, and what does this imply for sterility?

    The Arthrex Staples are designed for reuse, not single-use. Since they are reusable, they must be thoroughly cleaned, sterilized, and stored under controlled conditions between uses to ensure sterility and prevent cross-contamination. Proper handling and storage are essential to maintain their integrity and performance in subsequent procedures.

  • What sizes or models of Arthrex Staples are available, and how are they selected?

    The specifications provided do not detail specific sizes or model variants of the Arthrex Staples, but the system includes graduated guidewires and cannulated drills tailored for precise placement. Selection typically depends on the anatomical site, fracture type, and surgeon preference to ensure optimal compression and alignment during fixation. Consulting the manufacturer’s surgical technique guides is recommended for proper sizing.

  • How should the Arthrex Staples be stored to preserve their functionality?

    The Arthrex Staples should be stored in a clean, dry environment following standard orthopedic instrument protocols. This includes using protective cases or packaging to prevent damage, avoiding exposure to moisture or contaminants, and ensuring the set remains organized for easy access during surgery. Proper storage extends the lifespan of the reusable instruments and maintains their sterility for repeated use.