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K Number
K011451
Device Name
REUNITE FUSION SCREW
Manufacturer
BIOMET, INC.
Date Cleared
2001-12-10

(213 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K953194,K990291,K992301,K901456,K850631
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ReUnite™ Fusion Screw is indicated for proximal interphalangeal (PIP) joint arthrodesis and distal interphalangeal (DIP) joint arthrodesis in the presence of appropriate protection or immobilization.

Device Description

The ReUnite™ Fusion Screw is made out of LactoSorb® and has an elongated, tapered head at the proximal end, a smooth shaft in the middle, and a threaded portion at the distal end. A three-pronged driver is used to insert the threeshotted screw head. During insertion, as the threads gain purchase in the distal bone fragment, the tapered head is completely countersunk within the bone. After insertion, the driving head breaks off.

AI/ML Overview

This document, K0111451, is a 510(k) premarket notification for the ReUnite™ Fusion Screw. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, the requested information elements related to a study proving device meeting acceptance criteria cannot be extracted as such a study is not presented in this 510(k) summary. The FDA's determination is based on the device having the "same intended use and material, and similar design" to legally marketed predicate devices.

Here's an explanation for each requested element based on the provided text, indicating why certain information is not available:

  1. A table of acceptance criteria and the reported device performance

    • Not applicable / Not provided. This 510(k) submission does not establish or demonstrate performance against specific quantitative acceptance criteria for the ReUnite™ Fusion Screw. Instead, it argues for substantial equivalence based on intended use, material, and design similarity to predicate devices. There are no performance metrics or results presented that would fit into such a table.

  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Not applicable / Not provided. This 510(k) does not describe a clinical or performance study with a test set. The substantial equivalence argument relies on comparing the new device's characteristics to those of established predicate devices.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not applicable / Not provided. As no test set from a performance study is described, there's no mention of experts establishing ground truth for such a set.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not applicable / Not provided. No test set or related adjudication method is mentioned in this submission.

  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not applicable / Not provided. This document concerns a bone fixation screw; it is not an AI/imaging device, so an MRMC study or AI-related metrics are irrelevant and not included.

  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

    • Not applicable / Not provided. This is not an algorithm-based device.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • Not applicable / Not provided. No specific ground truth establishment is described for a performance study. The "ground truth" for this submission would essentially be the established safety and effectiveness of the predicate devices to which the ReUnite™ Fusion Screw is being compared.

  8. The sample size for the training set

    • Not applicable / Not provided. This submission does not describe a training set as it's not an AI/software device.

  9. How the ground truth for the training set was established

    • Not applicable / Not provided. As no training set is described, there's no information on how its ground truth was established.

§ 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.