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K Number
K150368
Device Name
Tarsa-Link Wedge Fixation System
Manufacturer
Life Spine
Date Cleared
2015-03-24

(40 days)

Product Code
HRS,HWC
Regulation Number
888.3030
Type
Special
Panel
OR
Reference & Predicate Devices
K141905
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Tarsa-Link Wedge Fixation and screws are intended to be used for internal bone fractures, fusions, or osteotomies in the ankle and foot, such as:

· Opening wedge osteotomies of Hallux Valgus

· Evans lengthening osteotomies

· Metatarsal/cuneiform arthrodesis

Device Description

The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot. The implant is available in a range of sizes and footprints to suit the individual anatomical conditions of the patient. Additionally, the wedge is fabricated and manufactured with two different materials: 1) Polyetheretherketone (PEEK) with tantalum markers and titanium pins (Ti 6Al-4V ELI). 2) Titanium (Ti 6Al-4V ELI).

The implant is hollow to permit packing with autogenous bone graft to help fusion. The implant has two pockets to permit placement of titanium bone screws (Ti 6A1-4V ELI) through the wedge to provide internal fixation.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the TARSA-LINK Stand-Alone Wedge Fixation System components with components from any other system or manufacturer. The TARSA-LINK Stand-Alone Wedge Fixation System components should never be reused under any circumstances.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device and thus does not contain information about the acceptance criteria or a study proving that an AI/ML device meets acceptance criteria. This documentation is for a physical medical device, the "TARSA-LINK Wedge Fixation System," which is a metallic bone fixation appliance.

The relevant sections of the document discuss:

  • Indications for Use: For internal bone fractures, fusions, or osteotomies in the ankle and foot.
  • Technological Characteristics: Substantially equivalent to predicate systems in design, materials, and indications for use.
  • Material: Manufactured from PEEK or Titanium, with tantalum markers and titanium pins.
  • Performance Data: "Benchtop testing and Finite Element Analysis was presented to demonstrate the substantial equivalency of the Tarsa-Link Wedge Fixation System."

There is no mention of an AI/ML component in this device, nor any acceptance criteria or studies related to AI/ML performance. Therefore, I cannot provide the requested information.

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.