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Orthomet Orthopedic Staples

by Orthomet, Inc.

510(k) K874914

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 NumberK874914 Date4 Feb 1988ClearedStatusActive

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  • Withdrawn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, 19 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 Orthomet Orthopedic Staples are classified as Staple, Fixation, Bone (product code JDR) and designed for internal fixation of bone fractures or surgical repairs. These staples provide secure, temporary stabilization by compressing bone fragments, aiding in proper alignment during the healing process. Their mechanical design is intended to distribute force evenly across fracture sites, reducing displacement risk.

Supplied as a sterile, single-use device, the Orthomet Orthopedic Staples are intended for use in orthopedic surgical settings under aseptic conditions. They are regulated under FDA 510(k) clearance (K874914) and fall under Class II – Special Controls. No MRI safety or reusable specifications are noted; storage must adhere to sterile packaging integrity until use.

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Questions

AI-generated answers, 19 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 bone injuries or surgical repairs are these staples designed to stabilize, and how do they work?

    The Orthomet Orthopedic Staples are specifically designed for internal fixation of bone fractures or surgical repairs, particularly to provide secure, temporary stabilization. They work by compressing bone fragments together, ensuring proper alignment during the healing process. Their mechanical design distributes force evenly across the fracture site, which helps minimize displacement risk while bones knit together.

  • Are these staples reusable, or are they meant for single-use only? How should they be stored?

    The Orthomet Orthopedic Staples are intended for single-use only and are supplied in sterile packaging. To maintain sterility, they must be stored according to the manufacturer’s instructions, ensuring the packaging remains intact until use. This is critical for orthopedic surgical settings where aseptic conditions are required.

  • What regulatory pathway was followed for FDA clearance, and what class does this device fall under?

    The Orthomet Orthopedic Staples were cleared through the FDA’s 510(k) process under a Traditional review route, with a decision date of February 4, 1988. The device is classified as Class II – Special Controls and falls under product code JDR (Staple, Fixation, Bone). The clearance number is K874914.

  • Can these staples be used in any MRI environment, or are there specific safety considerations?

    The Orthomet Orthopedic Staples do not have documented MRI safety specifications in the available data. If used in an MRI environment, clinicians should verify compatibility with their specific MRI system and consult the manufacturer’s guidelines to avoid potential risks, such as heating or image artifacts.