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FuseForce Implant System

by Solana Surgical, LLC

510(k) K124045

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 NumberK124045 Date10 Jul 2013ClearedStatusActive

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  • Withdrawn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, 6 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 FuseForce Implant System is a bone fixation staple device classified under product code JDR as Staple, Fixation, Bone. It is designed to provide fixation for fractures, fusions, or osteotomies of the bones of the hand and foot.

The system is supplied as a complete sterile kit and was cleared by the FDA through the 510(k) process (K124045) on July 10, 2013. It is a Class II device subject to special controls and was submitted by Solana Surgical, LLC.

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Questions

AI-generated answers, 6 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 is the FuseForce Implant System used for?

    The FuseForce Implant System is designed to provide fixation for fractures, fusions, or osteotomies of the bones in the hand and foot, functioning as a bone staple device under product code JDR.

  • How is the FuseForce Implant System supplied and is it sterile?

    The system is supplied as a complete sterile kit, meaning all components are sterilized and packaged together for single-use surgical procedures.

  • What regulatory pathway was used for the FuseForce Implant System?

    The FuseForce Implant System received FDA clearance through the 510(k) process under submission K124045, which was granted on July 10, 2013, and is classified as a Class II device.