LogoFDA 510(k) Search
K Number
K241416
Device Name
Ion 3D
Manufacturer
SurGenTec, LLC
Date Cleared
2024-06-17

(31 days)

Product Code
MRW,FMF,HTR
Regulation Number
N/A
Type
Special
Panel
OR
Reference & Predicate Devices
K240086
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse and for the delivery of hydrated allograft or autograft.

The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:

  • · Spondylolisthesis
  • · Spondylolysis
  • · Pseudoarthrosis or failed previous fusions which are symptomatic

· Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability

The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).

Device Description

The Ion 3D contains various sized facet screws with and without graft windows, for bilateral stabilization of the facets from C2-S1. The Ion 3D is provided in various configurations, including single-use, and reusable. The Instruments are offered in sterile and non-sterile configurations. All implants are manufactured from Ti6Al4V per ASTM F136.

AI/ML Overview

The provided document does not contain information related to software or AI-driven medical devices. The focus of this 510(k) submission is on a physical medical device, the "Ion 3D Facet Screw," and its accessories. The performance testing described is mechanical (e.g., axial pushout, static and dynamic three-point bend testing) to demonstrate the structural integrity and functionality of the physical screw and graft rasp.

Therefore, the requested information regarding acceptance criteria for device performance related to a study, the sample size for a test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training sets is not applicable to this document. These details are typically required for the validation of diagnostic or AI-based devices, not for the mechanical testing of an orthopedic implant.

N/A