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K Number
K230857
Device Name
TiLink-P SI Joint Fusion System
Manufacturer
Surgentec, LLC
Date Cleared
2023-09-25

(180 days)

Product Code
OUR
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K180818,K221047
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint.

The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink implant may be used standalone. The TiLink Implants are manufactured from titanium alloy and include the TiLink Locking Screw and the TiLink Compression Anchor. The TiLink Compression Anchor is designed to transfix the ilium and sacrum while compressing the SI joint. The TiLink Compression Anchor includes an opening to insert the TiLink Locking Screw. During the Procedure, the TiLink Compression Anchor is positioned so that it spans the ilium and sacrum, the TiLink Locking Screw is inserted through the TiLink Compression Anchor and along the SI Joint via a posterior approach. Bone graft material is placed within the TiLink implant to facilitate bone growth.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device. The document is an FDA 510(k) clearance letter for a TiLink-P SI Joint Fusion System, which is a physical implant for sacroiliac joint fusion, not an AI/ML device.

Therefore, I cannot provide the requested information, including:

  1. Table of acceptance criteria and reported device performance.
  2. Sample size and data provenance for a test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results.
  6. Standalone algorithm performance.
  7. Type of ground truth.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

Instead, the document details the regulatory clearance for a medical implant and lists non-clinical performance data for mechanical testing, biocompatibility, sterilization validation, and a side-by-side cadaver study to demonstrate substantial equivalence to predicate devices.

§ 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.