OSSIOfiber ® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, 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 body. The fibers are made of 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: 14- 50 mm long, and 3.5 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 the OSSIOfiber® Compression Screw, 3.5mm, a medical device used for bone fixation. The provided text is a 510(k) summary submitted to the FDA to gain clearance for marketing. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a study proving the device meets specific performance acceptance criteria in a clinical setting.

Therefore, the requested information elements related to clinical study design, expert evaluation, and AI performance metrics are not applicable to this document, as it outlines a pre-market notification process for a physical medical device based on non-clinical (mechanical) testing and comparison to existing devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to predicate devices, particularly the Tyber Medical Compression Screw (K133842) for mechanical performance. The "performance" here refers to mechanical properties, not clinical outcomes.

Acceptance Criterion (Implied)	Reported Device Performance (OSSIOfiber® Compression Screw, 3.5mm)
Pull-out Strength (Initial)	At least equivalent to the metal predicate device (K133842)
Pull-out Strength (After in-vitro degradation)	At least equivalent to the metal predicate device (K133842)
Torsional Strength (Time Zero)	Supported by testing and rationale
Driving Torque (Time Zero)	Supported by testing and rationale
Biocompatibility	Established based on primary predicate (K193660) and reference device (K203465)
In-vitro Degradation Profile	Established based on primary predicate (K193660) and reference device (K203465)
Material Composition	Same as primary predicate device (K193660)
Manufacturing and Sterilization Methods	Same as primary predicate device (K193660)
Principles of Operation	Same as primary predicate device (K193660)
Intended Use & Indications for Use	Same as primary predicate device (K193660)

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

The document does not specify a "test set" in the context of clinical data for AI, but rather references non-clinical (mechanical) testing.

Sample Size: Not explicitly stated for each test (e.g., number of screws tested for pull-out). It states "Pull-out testing was performed..." and "Torsional testing and rationale were also provided...".
Data Provenance: Non-clinical laboratory testing. No geographical or temporal provenance is mentioned, which is typical for such mechanical bench tests. This is not a human observational study.

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

Not Applicable. This is a physical medical device clearance based on non-clinical mechanical testing and comparison to predicate devices, not an AI or diagnostic imaging device requiring expert ground truth for image interpretation.

4. Adjudication Method

Not Applicable. As above, no expert adjudication was involved.

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

Not Applicable. This is not an AI-assisted diagnostic device.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Not Applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Mechanical Testing Results: Quantitative measurements of pull-out strength, torsional strength, and driving torque.
Comparison to Predicate Devices: Demonstrating equivalence or superiority in these mechanical properties to already cleared devices.
Validated Pre-clinical Studies: For biocompatibility and in-vitro degradation, referenced from the primary predicate and reference devices.

8. Sample Size for the Training Set

Not Applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning model.

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

Not Applicable. As above, there is no training set.

Summary

{0}------------------------------------------------

December 21, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

OSSIO Ltd. % David Mcgurl Director, Regulatory Affairs MCRA, LLC 803 7th Street NW Washington, District of Columbia 20001

Re: K213596

Trade/Device Name: OSSIOfiber® Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 12, 2021 Received: November 12, 2021

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.

{1}------------------------------------------------

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 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, 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/23See PRA Statement below.
510(k) Number ( if known )	K213596
Device Name	OSSIOfiber ® Compression Screw
Indications for Use ( Describe )	OSSIOfiber ® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average .79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human

Services Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

{3}------------------------------------------------

510(k) SUMMARY

OSSIOfiber® Compression Screw, 3.5mm

Submitter

Ossio Ltd.

8 HaTochen Street, Caesarea, Israel, 3079861 Phone: +972-4-9986600 Facsimile: +972-4-9986601 Contact Person: Taly Lindner Date Prepared: November 12, 2021

Name of Device: OSSIOfiber® Compression Screw, 3.5mm

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

Tyber Medical Compression Screw (K133842)

Reference Devices

OSSIOfiber® Cannulated Trimmable Fixation Nail (K203465)

Purpose of Submission

This traditional 510(k) premarket notification is submitted to obtain clearance for an additional screw design made of the same material including lengths outside the previously cleared range of the OSSIOfiber® Compression Screw family (named OSSIOfiber® Compression Screw, 3.5mm).

Device Description

{4}------------------------------------------------

K213596

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

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.

Summary of Technological Characteristics

The OSSIOfiber® Compression Screws, 3.5mm have the same intended use, indications for use, material composition, manufacturing and sterilization methods and principles of operation as the primary predicate device (K193660). Although there are differences with regards to shape and length as compared to the predicate devices, mechanical pull-out testing demonstrated at least equivalent performance both initially and after in vitro degradation. Any differences between OSSIOfiber® Compression Screws, 3.5mm and its predicate devices do not raise different questions of safety and effectiveness.

Non-Clinical Data

Pull-out testing was performed to verify the fixation properties of the OSSIOfiber® Compression Screw, 3.5mm, and to compare them to those of the metal predicate device (K133842). Testing was done initially and following in-vitro degradation. Torsional testing and rationale were also provided to support the torsional strength and driving torque at time zero for the OSSIOfiber® Compression Screw, 3.5mm.

In vitro degradation and biocompatibility for the implants were established based on the cleared primary predicate device (K193660) and referenced device (K203465). A rationale was provided to support the MR safe labeling of the device.

Conclusions

The OSSIOfiber® Compression Screw, 3.5mm is as safe and effective as its predicate devices. The OSSIOfiber® Compression Screws, 3.5mm have the same intended use, indications for use, material composition, manufacturing and sterilization methods and principles of operation as the primary predicate device (K193660). The minor design differences and additional lengths do not alter the intended surgical use of the device and do not affect its safety and effectiveness when used as labeled. Non-clinical pull-out testing data and torsional rationales demonstrate that the OSSIOfiber® Compression Screw, 3.5mm is at least as safe and effective as its predicates (K193642). Thus, the OSSIOfiber® Compression Screws, 3.5mm are substantially equivalent to its predicate 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.