OSSIOfiber® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization.

Device Description

The OSSIOfiber® Compression Screws are cannulated bone screws made of degradable poly (Llactide-co-D, L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Compression Screws are supplied sterile, for single patient use only. The screws are partially threaded and have a cannulated design. The additional devices included in this submission are: 65 - 100 mm long, and 6.5 mm diameter.

The OSSIOfiber® Compression Screws are designed to be used with commonly available orthopedic surgical tools such as ISO 5835/ISO 9714 compatible instrumentations.

AI/ML Overview

This document describes a 510(k) premarket notification for the OSSIOfiber® Compression Screw, 6.5mm, which is a line extension (longer lengths) of a previously cleared device. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study for a new diagnostic or AI-powered medical device. Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this submission.

Here's an analysis based on the provided text, indicating where information is not applicable (N/A) for this type of submission:

1. Table of acceptance criteria and the reported device performance:

Since this is a submission for a medical device (bone screw) based on substantial equivalence, the "acceptance criteria" are typically met by demonstrating that the new device has similar technological characteristics (material, design, intended use, etc.) to a legally marketed predicate and that any differences do not raise new questions of safety or effectiveness. Performance is typically established through non-clinical testing.

Acceptance Criteria Category	Reported Device Performance
Intended Use	Same as predicate (K193660): Maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization.
Indications for Use	Same as predicate (K193660): Maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization.
Material Composition	Same as predicate (K193660): Degradable poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers.
Design Characteristics	Same as predicate (K193660): Cannulated bone screws, partially threaded. New lengths: 65 - 100 mm long, 6.5 mm diameter (longer than previous cleared range).
Manufacturing and Sterilization Methods	Same as predicate (K193660).
Principles of Operation	Same as predicate (K193660).
New Performance Worst-Case	The additional lengths of the OSSIOfiber® Compression Screws, 6.5mm do not introduce a new performance worst-case relative to the cleared primary predicate.
Chemical Characterization	Completed; supports additional longer screw lengths.
Toxicological Risk Assessment	Completed; supports additional longer screw lengths.
Mechanical Performance Testing	Not performed for the subject lengths, as they "do not present a new worst case for the OSSIOfiber® Compression Screw family." The implication is that the performance of the predicate device is considered sufficiently representative or conservative for these longer lengths within the same family, or previous testing for the predicate already covered these mechanical aspects sufficiently. Previous testing likely included fatigue, torsional strength, bending strength, etc.
Similarities to Reference Device (K203105)	Additional longer lengths are similar to those of the Inion CompressOn™ Screw (K203105), which is cleared for similar indications and principles of operation/technological characteristics.

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

Sample Size: Not applicable. This submission relies on non-clinical testing (chemical characterization, toxicological assessment) and comparison to a predicate device, not a test set for diagnostic accuracy with a specific sample size of patients.
Data Provenance: The non-clinical data would typically originate from testing conducted by or for the manufacturer (Ossio Ltd. in Israel, per the address). The submission states "pre-clinical studies" for degradation, but details are not provided for the specific data.

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. There is no "ground truth" establishment in the context of an AI/diagnostic algorithm test set for this bone screw submission. The assessment is based on engineering principles, materials science, and regulatory comparison.

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

Not applicable. No diagnostic test set or adjudication process is mentioned.

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. This is for a physical medical device (bone screw), not an AI algorithm.

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

Not applicable. This is for a physical medical device (bone screw), not an AI algorithm.

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

Not applicable in the context of AI/diagnostic device ground truth. For this type of device, "ground truth" aligns with the established understanding of materials science, biomechanics, and the regulatory requirements for demonstrating safety and effectiveness of bone fixation devices, primarily through non-clinical testing and comparison to existing devices.

8. The sample size for the training set

Not applicable. This is for a physical medical device (bone screw), not an AI algorithm.

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

Not applicable. This is for a physical medical device (bone screw), not an AI algorithm.

Summary

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December 23, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.

OSSIO Ltd. % David Mcgurl Director, Regulatory Affairs Mcra. LLC 803 7th Street North West, Floor 3 Washington, District of Columbia 20001

Re: K221193

Trade/Device Name: OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 30, 2022 Received: November 30, 2022

Dear David Mcgurl:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali-S

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K221193

Device Name

OSSIOfiber® Compression Screw

Indications for Use (Describe)

OSSIOftber® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

OSSIOfiber® Compression Screw, 6.5mm

Submitter

Ossio Ltd.

8 HaTochen Street, Caesarea, Israel, 3079861 Phone: +972-4-9986600 Facsimile: +972-4-9986601 Contact Person: Taly Lindner

Date Prepared: November 30, 2022

Name of Device: OSSIOfiber® Compression Screw, 6.5mm Common or Usual Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II, 21 C.F.R. § 888.3040 Product Code: HWC

Predicate Devices

OSSIOfiber® Compression Screw (K193660) - Primary Predicate

Reference Devices

Inion CompressOn™ Screw (K203105) OSSIOfiber® Compression Screw (K213596)

Purpose of Submission

This traditional 510(k) premarket notification is being submitted to obtain clearance for a line extension, made from the same material of longer lengths, outside the previously cleared range of the OSSIOfiber® Compression Screw family (named OSSIOfiber® Compression Screw, 6.5mm).

Device Description

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The OSSIOfiber® Compression Screws are designed to be used with commonly available orthopedic surgical tools such as ISO 5835/ISO 9714 compatible instrumentations.

Indications for Use

Summary of Technological Characteristics

The OSSIOfiber® Compression Screws have the same intended use, indications for use, material composition, design characteristics, manufacturing and sterilization methods and principles of operation as the predicate device (K193660). The additional lengths of the OSSIOffiber® Compression Screws, 6.5mm do not introduce a new performance worst-case relative to the cleared primary predicate. The additional longer lengths of the subject device are similar to those of the Inion CompressOn™ Screw (K203105) which is cleared for similar indications with similar principles of operation and technological characteristics. Additional characterization testing has been completed, and together with a toxicological risk assessment support these additional lengths. Thus, any differences between OSSIOfiber® Compression Screws, 6.5mm and its predicate device do not raise different questions of safety and effectiveness.

Non-Clinical Data

Additional chemical characterization testing has been completed, and together with a toxicological risk assessment support the subject longer screw lengths. Additional mechanical performance testing was not performed as the subject lengths do not present a new worst case for the OSSIOfiber® Compression Screw family.

Conclusions

The OSSIOfiber® Compression Screws have the same intended use, indications for use, material composition, design characteristics, manufacturing and sterilization methods and principles of operation as the predicate device (K193660). The additional lengths do not alter the intended surgical use of the device and does not affect its safety and effectiveness when used as labeled. The additional lengths vs the predicate device raises no new issues of safety or effectiveness as supported by the chemical characterization data and toxicological risk assessment. The OSSIOfiber® Compression Screws is as safe and effective as its predicate device. Thus, the OSSIOfiber® Compression Screws is substantially equivalent to the predicate device.

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.