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Silhouette Spinal Fixation System Modification

by Sulzer Spine-Tech 2 variants

510(k) K992276

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 NumberK992276 Date1 Oct 1999ClearedStatusActive

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  • Withdrawn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)

Full name
Modification to Silhouette Spinal Fixation System
510(k) Number
FDA Product Code
MNI
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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 Silhouette Spinal Fixation System Modification is a posterior spinal fixation device designed for temporary internal fixation to correct spinal deformities and promote spinal fusion. It consists of hooks and screws intended for use in the thoracic, lumbar, and sacral regions of the spine. The system is engineered to provide stability during the fusion process, with components intended for eventual removal once solid fusion is achieved.

This modification is supplied as a reusable orthopedic implant system and is regulated under FDA 510(k) clearance (K992276) as substantially equivalent to existing devices. It is intended for use in skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint, particularly in cases involving autogenous graft fusions or lumbar/sacral fixation. The system adheres to orthopedic product standards and is classified under product code MNI.

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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 is the Silhouette Spinal Fixation System Modification used for?

    This modification is intended for temporary internal fixation to correct severe spinal deformities, specifically spondylolisthesis at the L5-S1 joint (Grades 3 and 4). It provides stability during spinal fusion procedures, particularly when using autogenous grafts or lumbar/sacral fixation. The system is engineered to be removed once solid fusion is achieved, ensuring long-term spinal alignment.

  • Is the Silhouette Spinal Fixation System Modification reusable?

    Yes, the system is supplied as a reusable orthopedic implant. It is designed for repeated use in clinical settings, adhering to orthopedic product standards while maintaining safety and efficacy for temporary spinal stabilization.

  • What regions of the spine does this modification target?

    The Silhouette Spinal Fixation System Modification is engineered for use in the thoracic, lumbar, and sacral regions of the spine. It is particularly focused on addressing severe spondylolisthesis at the L5-S1 joint, where hooks and screws provide targeted fixation.

  • Who is this device intended for?

    The modification is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 or 4) at the L5-S1 joint. It is specifically designed for use in cases involving autogenous graft fusions or lumbar/sacral fixation, ensuring compatibility with standard spinal fusion procedures.

  • How is the regulatory status of this device determined?

    The Silhouette Spinal Fixation System Modification received FDA 510(k) clearance (K992276) and is classified as substantially equivalent to existing devices. This regulatory pathway confirms its compliance with orthopedic product standards and ensures it meets safety and performance requirements for temporary spinal fixation.