The Inion FreedomScrew™M products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).

In addition, the Inion FreedomScrew™ Ø3.5/4.0/4.5 mm products are specifically intended for use in following indications:

A. General indications: maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.

B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.

Device Description

Inion FreedomScrew™ implants are internal fracture fixation devices made of degradable co-polymer composed of 100 % poly(L-lactide-co-D,L-lactide). Based on in vitro testing, the implants retain their initial strength up to 12 weeks after implantation, and gradually lose their strength thereafter. Bioresorption takes place within two to four years.

Inion FreedomScrews™ are in the range of diameter: 2.0 - 4.5 mm and length: 10 - 90 mm. The designs include fully and partially threaded screws, as well as solid and cannulated screws. Inion FreedomScrew™ implants are used together with the previously cleared Inion OTPS™ plating systems, as well as alone according to their indications for use. The Inion FreedomScrew™ products provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.

Inion FreedomScrews™ are provided sterile to the user and are non-collagenous. The shelf life of the device is 3 years and they are intended for single use only.

The Inion FreedomScrews™ are primarily designed to be used with customized Inion instrumentation, such as drill bits, bone taps, holding sleeves, screwdriver shafts, countersinks, depth gauges, K-wires and cutting instruments, as well as with ISO 5835/ISO 9714 compatible instrumentation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Inion FreedomScrew™ based on the provided text:

Acceptance Criteria and Device Performance

The provided text focuses on demonstrating substantial equivalence to predicate devices through various performance tests rather than setting explicit numerical acceptance criteria in the way one might see for an AI algorithm's diagnostic accuracy. The key acceptance criteria here are successful comparison to predicate devices across different mechanical and functional properties.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Degradation Profile	- Retain initial strength up to 12 weeks after implantation. - Gradually lose strength thereafter. - Bioresorption within two to four years. - Sufficient mechanical stability over the healing period as the polymer degrades. - Ensure degradation of the Inion FreedomScrews™.	- "Bioreabsorption takes place within two to four years." - "Based on in vitro testing, the implants retain their initial strength up to 12 weeks after implantation, and gradually lose their strength thereafter." - "In vitro degradation testing was carried out to determine the degradation profile (i.e., change in material and mechanical properties) and verify the sufficiency of the mechanical stability over healing period as the polymer degrades and to ensure the degradation of the Inion FreedomScrews™." (Implies successful verification)
Mechanical Strength	- Comparable shear properties to predicate devices. - Comparable torsion properties to predicate devices. - Comparable pull-out properties to predicate devices. - Comparable fixation properties with Inion FreedomPlate™ to predicate devices.	- "Mechanical shear, torsion and pull-out tests were performed to verify the strength properties of Inion FreedomScrew™ implants and to compare them to the predicate devices." (Implies successful comparison/verification) - "Mechanical fixation test was performed to verify the properties of Inion FreedomScrew™ with the Inion FreedomPlate™ and to compare them to the fixation properties of the predicate devices." (Implies successful comparison/verification)
Functional & Handling	- Implants, accessory instruments, packaging, and instructions for use function together as intended. - Conform to defined user needs and intended uses. - Favorable comparison to predicate devices in functionality and handling.	- "Functional and handling test and simulated clinical use test were performed to verify that the implants, accessory instruments, packaging and instructions for use are functioning together as intended, and conform to the defined user needs and intended uses." - "The tests were done also in comparison to the predicate devices." - "The devices have passed the tests for functionality and handling in simulated clinical use settings and compare favourably to the predicate devices."
Substantial Equivalence	- The intended use, material composition, scientific technology, degradation profile, and mechanical properties of Inion FreedomScrew™ are substantially equivalent to the predicate devices (Inion OTPS™ Mesh System K031961, Inion OTPS™ Mini Screws K043142, and Inion OTPS™ Fixation System K030900).	- "The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion FreedomScrew™ are substantially equivalent with the predicate devices Inion OTPS™ Mesh System (K031961), Inion OTPS™ Mini Screws (K043142) and Inion OTPS™ Fixation System (K030900)."

Study Information

The provided document describes physical and mechanical testing of a medical device (bone screw), not an AI-powered diagnostic device. Therefore, many of the requested fields are not applicable in this context.

Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a number of cases or patients. The testing involved "Inion FreedomScrew™ implants" and comparisons to predicate devices. The specific number of screws or test specimens used for each mechanical and degradation test is not provided.
- Data provenance: The tests were "in vitro," implying laboratory-based testing rather than studies on human or animal subjects. No country of origin for the data is specified, but the manufacturer is based in Finland (Inion Oy, Tampere, Finland).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were engineering/mechanical performance tests, not clinical studies requiring expert ground truth for interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This was mechanical and material performance testing, not a clinical study with image or data interpretation.
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. This device is a physical bone screw, not an AI system for human reader assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device is established by engineering and material science principles, measured physical properties (e.g., strength, degradation rate), and comparison against established predicate device performance and regulatory standards for biocompatibility and mechanical integrity.
The sample size for the training set: Not applicable. This document describes testing of a physical device, not a machine learning model that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K123672 (pg 1/2

510(k) SUMMARY Inion FreedomScrewTM

FEB 2 7 2013

Image /page/0/Picture/3 description: The image shows the word "INION" in bold, white letters against a black background. The letters are large and fill most of the frame. The background has a grainy texture, which contrasts with the smooth, solid letters. The overall impression is simple and graphic.

Manufacturer and submitter:	Inion Oy,Lääkärinkatu 2,FIN-33520 Tampere, FINLAND
Date of this summary:Contact person	November 23, 2012Kati Marttinen, Quality and Regulatory DirectorPhone: +358 10 830 6600Fax: +358 10 830 6691kati.marttinen@inion.com
Establishment registrationnumber	9710629
Trade name of the device	Inion FreedomScrewTM
Device classification andproduct code	Class IIClassification Panel: OrthopaedicProduct Code: HWCCommon name: Bone screwRegulation number: 888.3040
Predicate device	K031961 K043142 K030900
Conformance with performancestandards	No applicable mandatory performance standards exist forthis device. Compliance to voluntary consensus standards islisted in the application.

Device description and principles of operation

Inion FreedomScrews™ are provided sterile to the user and are non-collagenous. The shelf life of the device is 3 years and they are intended for single use only.

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510(k) SUMMARY Inion FreedomScrew™

Image /page/1/Picture/2 description: The image shows the word "INION" in white letters against a black background. The letters are bold and sans-serif. The background appears to have a grainy or textured quality, possibly due to noise or artifacts in the image.

Indications for use

In addition, the Inion FreedomScrew™ Ø3.5/4.0/4.5 mm products are specifically intended for use in following indications:

A. General indications: maintenance of reduction of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.

B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.

Performance testing for substantial equivalence determination

Mechanical shear, torsion and pull-out tests were performed to verify the strength properties of Inion FreedomScrew™ implants and to compare them to the predicate devices. Mechanical fixation test was performed to verify the properties of Inion FreedomScrew™ with the Inion FreedomPlate™ and to compare them to the fixation properties of the predicate devices. Fixation tests with Inion FreedomPlate™ included the technique of removing the screw heads after insertion by cutting forceps or heat loop device, where plate-screw interface creates appropriate grip and secures fixation.

In vitro degradation testing was carried out to determine the degradation profile (i.e., change in material and mechanical properties) and verify the sufficiency of the mechanical stability over healing period as the polymer degrades during in vitro degradation and to ensure the degradation of the Inion FreedomScrews™.

Functional and handling test and simulated clinical use test were performed to verify that the implants, accessory instruments, packaging and instructions for use are functioning together as intended, and conform to the defined user needs and intended uses. The tests were done also in comparison to the predicate devices.
The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion FreedomScrew" are substantially equivalent with the predicate devices Inion OTPS_"" Mesh System (K031961), Inion OTPS™ Mini Screws (K043142) and Inion OTPS™ Fixation System (K030900). The devices have passed the tests for functionality and handling in simulated clinical use settings and compare favourably to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 27, 2013

Inion Oy % Ms. Kati Marttinen Quality and Regulatory Director Lääkärinkatu 2 335200 Tampere Finland

Re: K123672

Trade/Device Name: Inion FreedomScrewTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 23, 2012 Received: November 29, 2012

Dear Ms. Marttinen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Ms. Kati Marttinen

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin I.D.Keith

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number:

K123672 (pg 1/1)

Device Name:

Inion FreedomScrew™M

The Inion FreedomScrew™ products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).

In addition, the Inion FreedomScrew™ Ø3.5/4.0/4.5 mm products are specifically intended for use in following indications:

B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

ElizabethLMFrank-S

Divison of Orthopedic Devices

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.