SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X by SINTEA BIOTECH, INC.

The Intended Use of the Sintea Biotech Traumafix (TFX) System is to obtain a safe, nonrigid fixation, to stimulate bone re-growth. The function of the Schanz Screw is to transfer axial forces between the bones and the rings of TFX system, in a mono-lateral construct. The Sintea Biotech external fixation screw is indicated for use in the external fixation of bone.

Device Description

Schanz's screws are components of the Sintea Traumafix (TFX) system and were developed for external fixation according to Ilizarov's principle to treat severe articular fractures, pseudo-arthrosis and limb lengthening. The purpose of the TFX system is to obtain a safe, non-rigid fixation, to stimulate bone re-growth. The function of the Schanz's screws is to transfer axial forces between the bones and the rings of TFX system, in a mono-lateral construct. The Schanz's screws are available in three different diameters (4.0, 5.0, 6.0 mm) and three different lengths (120, 150, 180 mm). They consist of round bars having a thread at one end and a square tang at the other end to allow for easy screwing. Furthermore, the threaded length may be interrupted to allow bi-cortical fixation. The special shape of the threaded extremity makes the screws self-tapping.

AI/ML Overview

Here's an analysis of the provided text regarding the Sintea Biotech Traumafix System with Schanz Screw, focusing on acceptance criteria and supporting studies:

This document is a 510(k) premarket notification for a medical device (Sintea Biotech Traumafix System with Schanz Screw). For such submissions, the acceptance criteria and study data typically revolve around demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving novel clinical effectiveness through extensive human trials. Therefore, the information provided is structured differently than what one might expect for a new drug or a high-risk novel device requiring de novo authorization or a PMA.

Based on the provided text, the device's acceptance criteria and the "study" that proves it meets them are primarily focused on mechanical testing and comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness for Intended Use (Overall Goal)	"Mechanical tests of the Sintea Biotech Traumafix System with Schanz Screw demonstrate that the device is safe and effective for its intended use." (General statement)
Substantial Equivalence to Predicate Device (Key Criterion)	The device is found substantially equivalent to the Howmedica Osteonics Corp.'s Apex Fixation Pins (K011136, K861766). This is based on similarities in: - Intended use and indications - Screw component material - External portion material - Mode of fixation - Form, function, components, instruments, geometry, features, and packaging - Labeling (non-sterile, sterilization required prior to use) "In summary, the use of OSR-based process controls, testing standards, material standards and similarities to the predicate device establish that the Sintea Biotech Traumafix System's with Schanz Screw is equivalent to Howmedica Osteonics Corp.'s Apex Fixation Pins and that it is safe and effective for its intended use."
Meet applicable Testing Standards (Implied by "testing standards")	"Mechanical tests... demonstrate that the device is safe and effective." (No specific standards are listed in the provided text, but it implies compliance with relevant mechanical testing standards for bone fixation devices.)
Material Compatibility/Safety (Implied)	"the screw components are made of the same materials" as the predicate device. "the external portion of the devices is made of the same material" as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states "Mechanical tests" were performed, but it does not specify the sample size for these tests. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). This is typical for 510(k) submissions focusing on bench testing rather than clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of submission. The "ground truth" for demonstrating substantial equivalence here is primarily established through direct comparison of materials, design, and performance in mechanical tests against a predicate device, not through expert review of clinical cases or images.

4. Adjudication Method for the Test Set

This information is not applicable as there is no expert review or human-in-the-loop performance measurement described in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is subject to a 510(k) clearance, which primarily relies on demonstrating substantial equivalence through bench testing and comparison to a predicate, not clinical efficacy studies involving human readers or AI assistance.

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

No, this product is a physical medical device (bone fixation system) and does not involve any algorithms or software that would have standalone performance.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" is primarily based on:

Engineering specifications and material standards: Ensuring the device meets predefined criteria for strength, durability, and biocompatibility.
Direct comparison to a predicate device's established characteristics: The predicate device (Howmedica Osteonics Corp.'s Apex Fixation Pins) serves as the benchmark against which the new device is found "substantially equivalent" in design, materials, and intended function.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as above.

Summary

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031154
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SUMMARY OF SAFETY AND EFFECTIVENESS Sintea Biotech Traumafix System with Schanz Screw

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k) premarket notification is in accordance with 21 CFR 807.87 and the SMDA.

1. Submitter of 510(k)
  JUN 2 4 2003

Marianne Grunwaldt Regulatory Affairs Specialist Sintea Biotech, Inc. 407 Lincoln Road Ste 10L Miami Beach, FL 33139

Telephone: (305) 673-6226 Facsimile: (305) 673-3312

1. Name of Device
- 2.1 Trade / Proprietary Name
  - Sintea Biotech Traumafix System with Schanz Screw
- 2.2 Common / Usual Name Fixation Pins
- 2.3 Classification Name Smooth or threaded bone fixation fastener (21 CFR 888.3040)
1. Applicant / Manufacturer Sintea Biotech, Srl. Via Aquileia 33/H Baranzate Milano, Italy

Telephone: 011-39-02-38204222 Facsimile: 011-39-02-38204230

1. Reason for Submitting the 510(k)
  Sintea Biotech, Inc. intends to commercially distribute a modified version of its previously 510(k)-cleared Traumafix external fixation system. Sintea Biotech wishes to distribute the Traumafix system with an additional Schanz screw component.
1. Device Description
  Schanz's screws are components of the Sintea Traumafix (TFX) system and were developed for external fixation according to Ilizarov's principle to treat severe articular fractures, pseudo-arthrosis and limb lengthening. The purpose of the TFX system is to obtain a safe, non-rigid fixation, to stimulate bone re-growth. The function of the Schanz's screws is to transfer axial forces between the bones and the rings of TFX system, in a mono-lateral construct. The Schanz's screws

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K031154
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are available in three different diameters (4.0, 5.0, 6.0 mm) and three different lengths (120, 150, 180 mm). They consist of round bars having a thread at one end and a square tang at the other end to allow for easy screwing. Furthermore, the threaded length may be interrupted to allow bi-cortical fixation. The special shape of the threaded extremity makes the screws self-tapping.

Mechanical tests of the Sintea Biotech Traumafix System with Schanz Screw demonstrate that the device is safe and effective for its intended use.

1. Predicate Device Identification and Statement of Technological Comparison
  The Sintea Biotech Traumafix System (K022065, Decision Date 08/06/2002) was found to be substantially equivalent to referenced predicate device(s). This new 510(k) submission seeks to add a Schanz Screw component to the approved system. Other marketed external fixation systems that are similar to the Traumafix System incorporate screw components into their design. One such system, Howmedica Osteonics Corp.'s Apex Fixation Pins (K011136, Decision Date 05/04/2001, and K861766, Decision Date 07/08/1986) is the predicate device for this submission. The Sintea Biotech Traumafix System's Screw and Howmedica Osteonics Corp.'s Apex Fixation Pins are similar in that:
the devices have the same intended use and indications for use ●
the screw components are made of the same materials ●
the external portion of the devices is made of the same material ●
the mode of fixation of the devices is identical ●
the devices have similar form, function, components, instruments, geometry, ● features and packaging
the devices have the same labeling and are both sold non-sterile with sterilization ● required prior to use.

In summary, the use of OSR-based process controls, testing standards, material standards and similarities to the predicate device establish that the Sintea Biotech Traumafix System's with Schanz Screw is equivalent to Howmedica Osteonics Corp.'s Apex Fixation Pins and that it is safe and effective for its intended use.

7. Intended Use

8. Indications for Use

The Sintea Biotech Schanz Screw is indicated for use in the external fixation of bone.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with three lines representing the feathers. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2003

Ms. Marianne Grunwaldt Regulatory Affairs Specialist Sintea Biotech, Inc. 407 Lincoln Road, Suite 10L Miami Beach, FL 33139

Re: K031154

Trade/Device Name: Sintea Biotech Schanz Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: April 10, 2003 Received: May 28, 2003

Dear Ms. Grunwaldt:

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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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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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

Sincerely yours,

Mark A. Milken

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

Enclosure

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JUN 2 4 2003

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510(k) Number (if known): K0.31154

Sintea Biotech Schanz Screw
Device Name:

Indications For Use:

The Sintea Biotech external fixation screw is indicated for use in the external fixation of bone.

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Mark A. Melkus

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

Number K031154

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.