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:

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.
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.
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.
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.
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.
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.
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.
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.
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.

Summary

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K011451

DEC 1 0 2001 SUMMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:	Biomet, Inc.P.O. Box 587Warsaw, IN 46581-0587
Contact Person:	Sara Bailey ShultzRegulatory Specialist
Proprietary Name:	ReUnite™ Fusion Screw
Common or Usual Name:	Arthrodesis screw
Classification Name:	Screw, Fixation, Bone, Non-spinal, Non-metallic(888.3040)Pin, Fixation, Smooth, Non-metallic (888.3040)
Device Product Code:	87HWC and HTY

Substantially Equivalent Devices: LactoSorb® Bone Pin (K953194 and K990291), ReUnite™ Screw (K992301), OrthoSorb® Absorbable Pin (K901456), Kirschner Orthopedic Wire (K850631)

Indications for 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.

Basis of Substantial Equivalence: The ReUnite™ Fusion Screw has the same intended use and material, and similar design when compared to the following bone fixation devices:

1. LactoSorb® Bone Pin, Biomet Inc., K953194 and K990291
1. ReUnite™ Screw, Biomet Inc., K992301
1. Kirschner Orthopedic Wire, Kirschner Medical Corporation, K850631

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2001

Ms. Sara Bailey Shultz Regulatory Specialist Biomet P.O. Box 587 Warsaw, Indiana 46581

Re: K011451

Trade/Device Name: ReUnite™ Fusion Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: September 26, 2001 Received: September 28, 2001

Dear Ms. Shultz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Sara Bailey Shultz

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, MD

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1191145 510(k) NUMBER (IF KNOWN):_

DEVICE NAME: ReUnite™ Fusion Screw

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

S Prescription Use (Per 21 CFR 801.109

Over-The-Counter-Use
(Optional Format 1-2-96)

Susan weller (Division Sign-Off) Division of General, Restorative and Neurological Devices

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KO11451 510(k) Number _

Regulation Number and Section

§ 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.