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K Number
K240201
Device Name
PathLoc SI Joint Fusion System
Manufacturer
L&K Biomed Co., Ltd.
Date Cleared
2024-02-23

(29 days)

Product Code
OUR
Regulation Number
888.3040
Type
Special
Panel
OR
Reference & Predicate Devices
K231841
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PathLoc SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description

The PATHLOC SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136. This submission adds an additional screw option to the system.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device called the "PathLoc SI Joint Fusion System." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to AI or algorithm performance.

The content of the provided text focuses on:

  • The FDA's determination of substantial equivalence to a predicate device.
  • Regulatory requirements and classifications.
  • Description of the device and its intended use (sacroiliac joint fusion).
  • Material composition.
  • A brief mention of "performance testing" through engineering analysis, stating that added components do not introduce a "new worst case" and don't require additional mechanical testing. This refers to mechanical integrity and safety of the implant itself, not AI performance.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria, as the provided text does not contain this information. The device in question is a physical implant (bone screws), not a software or AI-driven diagnostic or therapeutic device.

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.