Skip to content

Synthes (Usa) Retrograde/Antegrade Femoral Nail System

by Synthes (Usa)

510(k) K033618

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK033618 Date5 Feb 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2058-2013 FDA Class II initiated 2 Nov 2012

    Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.

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  • Withdrawn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
HSB
Device Class
Class II
Regulation
21 CFR Part 888.3020
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.

Intramedullary fixation system for stabilization of distal femur and femoral shaft fractures. Components include titanium alloy femoral nails, spiral blades, and end caps; used with locking bolts and screws to secure nail in bone, preventing rotation and axial compression.

Inserted via retrograde or antegrade approach depending on nail length. Used by orthopedic surgeons in clinical settings. Supplied as a non-sterile system requiring sterilization prior to use. Authorized under FDA 510(k) clearance K033618.

Other devices from Synthes (Usa)

See all devices from Synthes (Usa) →

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 Synthes Retrograde/Antegrade Femoral Nail System used for?

    The system is used for intramedullary fixation to stabilize distal femur and femoral shaft fractures. It includes titanium alloy femoral nails, spiral blades, and end caps that are secured with locking bolts and screws to prevent rotation and axial compression in the bone.

  • How is the Synthes femoral nail system supplied and prepared for use?

    The system is supplied as a non-sterile set of components, including nails, blades, end caps, locking bolts, and screws. It must be sterilized by the healthcare facility prior to surgical use to ensure patient safety.

  • What surgical approaches are supported by the Synthes femoral nail system?

    The system supports both retrograde and antegrade insertion approaches. The choice between these approaches depends on the specific nail length and the anatomical location of the fracture being treated.

  • What regulatory pathway was used for the Synthes femoral nail system?

    The device received authorization through the FDA 510(k) clearance process under submission K033618, which determined it to be substantially equivalent to a legally marketed predicate device.