The Orthofix Hydroxyapatite Coated Screws are manufactured from surgical grade stainless steel AISI 316L. The pins are available in a variety of diameters and lengths. The threaded end is gradually tapered, over approximately the last third of the pin's length. The threaded portion of the pin is coated with a very thin plasma sprayed coating of HA. The HA powder used in the plasma spray coating process conforms to ASTM F 1185. The mechanical properties of the coating conform to ASTM F 1501.

AI/ML Overview

The provided 510(k) summary (K974186) describes the Orthofix® External Fixation Screw (Pin) With Hydroxyapatite Coating. This submission is for a modified version of an already cleared external fixation pin, with the modification being the addition of a thin plasma-sprayed coating of hydroxyapatite (HA). The purpose of the HA coating is to enhance fixation at the pin/bone interface.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal "acceptance criteria" in a quantitative sense as typically seen for AI/software devices. Instead, it argues for substantial equivalence to a predicate device based on demonstrating enhanced performance attributable to the HA coating. The performance metrics presented are comparative between HA-coated and uncoated pins.

Acceptance Criteria (Implied)	Reported Device Performance (HA-Coated vs. Uncoated)
No significant difference in insertion torque.	No significant difference in insertion torques for standard uncoated and HA-coated Orthofix pins in both metaphyseal and diaphyseal bone.
Significantly greater extraction torque than uncoated pins.	Extraction torque is significantly greater for HA-coated Orthofix pins than for uncoated pins in both metaphyseal and diaphyseal bone.
Extraction torque significantly greater than insertion torque.	For HA-coated Orthofix pins, the extraction torque is significantly greater than the insertion torque in both metaphyseal and diaphyseal bone.
Reduced incidence of clinical loosening.	Significantly enhanced fixation and a reduced incidence of clinical loosening.
Osseointegration demonstrated.	Radiographic, histologic, SEM, and histomorphometric analyses demonstrate osseointegration with direct contact between the bone and the screw threads of the Orthofix HA-coated pins.

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

The document mentions "randomized controlled clinical and animal studies" but does not specify the sample sizes for either the clinical or animal studies.

The provenance of the data is not explicitly stated (e.g., country of origin for clinical studies). It's implied to be prospective given the description of "randomized controlled clinical and animal studies."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies involved radiographic, histologic, SEM, and histomorphometric analyses, which would typically involve expert interpretation, but no details on the number or qualifications of these experts are given.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not applicable here as this is a medical device (external fixation screw) rather than an AI/software device intended for interpretation by multiple readers. The study focuses on the physical and biological performance of the device.

6. Standalone (Algorithm Only) Performance

This is not applicable as the device is a physical medical implant, not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth was established through a combination of:

Quantitative Mechanical Measurements: Insertion and extraction torque measurements.
Imaging Data: Radiographic analyses.
Histology: Histologic analysis (tissue samples).
Microscopy: SEM (Scanning Electron Microscopy) and histomorphometric analyses (detailed microscopic examination and measurement of bone-implant interface).
Clinical Outcomes: Reduced incidence of clinical loosening (though the specific metrics or details of this outcome are not elaborated).

8. Sample Size for the Training Set

This is not applicable as this is a physical medical device and does not involve AI or machine learning algorithms that would typically have a "training set." The HA coating is applied directly to the device.

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

This is not applicable for the reasons stated above. The "ground truth" for the device's performance was established via the described clinical and animal studies and mechanical/material characterization tests.

Summary

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MAR 1 8 1998

K974186

510(k) SUMMARY1 Orthofix® External Fixation Screw March 3, 1998

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

1. Submitter of 510(k)

Robert L. Sheridan (Consultant) Vice President, Device Evaluation C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, MD 20852

Telephone: (301) 770-9590 Facsimile: (301) 770-9584

2. Name of Device

2.1 Trade/Proprietary Name

Orthofix® External Fixation Screw (Pin) With Hydroxyapatite Coating

2.2 Common/Usual Name

External fixation pin

2.3 Classification Name

Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040).

3. Applicant/Manufacturer

ORTHOFIX Srl. Via delle Nazioni 9 37012 Bussolengo (VR), Italy Attention: Rolando Stanghellini, Director of Quality Assurance

Telephone: 011-39-45-6767030 Facsimile: 011-39-45-6767135

4. Reason for Submitting the 510(k)

Orthofix intends to commercially distribute a modified version of its previously 510(k)-cleared external fixation pin. Orthofix wishes to distribute its pins with a verv thin plasma sprayed coating of hydroxyapatite (HA).

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5. Device Description

6. Indications For Use

The Orthofix external fixation screw (pin) with hydroxyapatite coating is indicated for use in the external fixation of bone.

Substantial Equivalence 7.

The decision that the Orthofix HA coated pin is substantially equivalent to a legally marketed predicate device is reached through consideration of the requirements for substantial equivalence determinations. These requirements are set forth in the document entitled "Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program", which was published on June 30, 1986 by the Center for Devices and Radiological Health (CDRH),

FDA guidance documents relevant to this application were used in its preparation. In particular, the guidance document, "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants" (revised February 20.1997), was followed in the preparation of this 510(k). The physical, mechanical and chemical tests prescribed by FDA in its guidance document to characterize the HA coating and HA/substrate interface were conducted.

The substantial equivalence of the Orthofix HA coated pins is supported by the extensive laboratory, animal and clinical testing data presented herein. The preclinical and clinical data presented herein demonstrate that the use of the proprietary HAcoating enhances fixation at the pin/bone interface. The Orthofix HA-coated pins demonstrate statistically significantly better stability or fixation at the time of removal or extraction than do the uncoated pins.

Orthofix pins with the proprietary HA-coating were found in randomized controlled clinical and animal studies to have significantly enhanced fixation and a reduced incidenced of clinical loosening. The clinical results demonstrate:

No significant difference in the insertion torques for standard uncoated and HA-● coated Orthofix pins in both metaphyseal and diaphyseal bone.
The extraction torque is significantly greater for HA-coated Orthofix pins than for ● uncoated pins in both metaphyseal and diaphyseal bone.

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For the HA-coated Orthofix pins, the extraction torque is significantly greater than . the insertion torque in both metaphyseal and diaphyseal bone; whereas, for the uncoated pins, the extraction torque is significantly lower than the insertion torque in both metaphyseal and diaphyseal bone.
The animal study that was conducted compared uncoated and HA-coated Orthofix pins. Radiographic, histologic, SEM and histomorphometric analyses demonstrate that osseointegration with direct contact between the bone and the screw threads of the Orthofix HA-coated pins.

As reported in the literature, complications of external fixation include pin tract infection and loosening. The enhanced fixation and improved stability at the bonepin interface seen with the Orthofix Ha-coated pins significantly reduces the incidence of pin loosening. It is generally accepted that a loose pin provides an increased risk of infection.

In summary, the information and data provided in this submission are consistent with FDA's guidance documents for HA coated orthopedic implants and demonstrate that the Orthofix HA coated pin is substantially equivalent to legally marketed predicate devices.

1 Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to refer to whether the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. (Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355))

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 1998

ORTHOFIX Srl. c/o Mr. Robert L. Sheridan Vice President, Device Evaluation C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

K974186 Re: Orthofix® External Fixation Screw (Pin) Trade Name: with Hydroxyapatite Coating Regulatory Class: II Product Code: JDW Dated: March 3, 1998 March 4, 1998 Received:

Dear Mr. Sheridan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with ----the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Robert L. Sheridan

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Rumell U. Sager.

Ar 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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Indications For Use

Device Name: Orthofix External Fixation Screw (Pin) With Hydroxyapatite Coating

The Orthofix external fixation screw (pin) with hydroxyapatite Indications For Use: coating is indicated for use in the external fixation of bone.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

Over-The-Counter:

Russell H. Rogers
Division Sign-Off

(Optional Format 1-2-96)

Division Sign-Off)
Casion of General Restorative Devices
510(k) Number K974186

1 1/5/971 1:11

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.