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Acromed Washers

by Buckman Co., Inc. 510(k)

Active United States

510(k) K881699

Overview

The Ace Orthopaedic Washers are orthopedic fixation devices designed for internal fixation of long bone fractures. These washers are intended to secure bone plates to the bone, providing stability during the healing process by distributing load and preventing plate loosening.

Supplied as single-use devices, the Ace Orthopaedic Washers are classified under FDA product code HTN and were granted 510(k) clearance as substantially equivalent. They are intended for use in orthopedic surgical settings and must be handled with sterile techniques. Storage and handling comply with standard orthopedic implant protocols, ensuring compatibility with surgical environments.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881699 Date27 Apr 1988ClearedStatusActive

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

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Questions

  • What are the Ace Orthopaedic Washers used for?

    The Ace Orthopaedic Washers are designed specifically for internal fixation of long bone fractures. They secure orthopedic plates to bone, distributing mechanical load to stabilize the fracture site and prevent plate loosening during the healing process. This design helps maintain proper alignment and promotes effective bone union.

  • Are the Ace Orthopaedic Washers single-use or reusable?

    The Ace Orthopaedic Washers are supplied as single-use devices. This ensures sterility and reduces the risk of cross-contamination in surgical settings, adhering to standard orthopedic implant protocols. Single-use devices are also aligned with best practices for infection control and patient safety.

  • How should the Ace Orthopaedic Washers be stored?

    The washers must be stored according to standard orthopedic implant protocols to maintain compatibility with surgical environments. Proper storage conditions—such as dry, sterile packaging and protection from contamination—are critical to preserve their integrity and functionality. Always follow manufacturer guidelines for handling and storage to ensure readiness for use.

  • What regulatory pathway does the Ace Orthopaedic Washer follow?

    The Ace Orthopaedic Washers were granted FDA 510(k) clearance under the Traditional review pathway, classified under product code HTN (Orthopedic Devices). The clearance was based on a determination of substantial equivalence to a predicate device, ensuring compliance with FDA requirements for orthopedic fixation devices.

  • Can these washers be used in any orthopedic surgical setting?

    Yes, the washers are intended exclusively for use in orthopedic surgical settings where long bone fracture fixation is performed. They are engineered to work with bone plates and require sterile handling techniques to prevent infection. Always verify compatibility with the specific surgical procedure and consult relevant clinical guidelines before use.