The OIC FLEX-FIX™ System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruption) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C. The device is intended for use in adults.

Device Description

The OIC FLEX-FIX™ System consists of a medial toggle body, UHMWPE suture tape and a lateral button assembled on a deployment handle, a 3.7mm drill bit, and a 3.5mm washer. The device is provided sterile. EO gas is used to sterilize the device.

The medial toggle body, lateral button and washer are manufactured from material that conforms to: ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Ally for Surgical Implant Applications (UNS R56401)

AI/ML Overview

This document, K233531, is an FDA 510(k) clearance letter for a medical device called the OIC FLEX-FIX™ System, which is an orthopaedic implant for ankle fixation. The provided information focuses on the device's substantial equivalence to predicate devices and does NOT contain any data related to AI/ML software performance or an AI study. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML, as no such study is described in this document.

The document discusses:

The device's intended use for ankle syndesmosis and fractures.
The device's components and materials.
A comparison to predicate devices, noting similarities in intended use, operating principle, and design, and differences in material and toggle body dimensions.
Performance testing: "Dynamic tensile testing and Static testing to failure was performed on the device and a predicate. The device was found to have acceptable mechanical characteristics for the intended uses." This refers to biomechanical testing of the physical implant, not a study of AI/ML software performance.

Therefore, I cannot fulfill your request for the following information based on the provided document:

A table of acceptance criteria and the reported device performance (in the context of AI/ML).
Sample size used for the test set and data provenance (for AI/ML).
Number of experts used to establish ground truth and their qualifications (for AI/ML).
Adjudication method (for AI/ML).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done (for AI/ML).
If a standalone (algorithm only) performance study was done (for AI/ML).
The type of ground truth used (for AI/ML).
The sample size for the training set (for AI/ML).
How the ground truth for the training set was established (for AI/ML).

The document is solely about the clearance of a mechanical orthopaedic implant based on substantial equivalence to existing devices and standard mechanical testing.

Summary

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February 2, 2024

Orthopaedic Implant Company Douglas Fulton Quality Assurance Manager 770 Smithridge Dr. #400 Reno, Nevada 89502

Re: K233531

Trade/Device Name: OIC FLEX-FIXTM System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: October 30, 2023 Received: November 2, 2023

Dear Douglas Fulton:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).

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Sincerely,

Limin Sun -S

Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty 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) K233531

Device Name OIC FLEX-FIX System

Indications for Use (Describe)

The OIC FLEX-FIX System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruption) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C. The device is intended for use in adults.

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

Prepared 01/29/2024

Name and Address of Manufacturer: The Orthopaedic Implant Company (OIC) 770 Smithridge Drive. Suite 400 Reno, NV 89502

Contact: Douglas Fulton Quality Assurance Manager Telephone: 775-636-8281 Fax: 775-636-8284 Email: doug@orthoimplantcompany.com

Device Identification: Trade Name: OIC FLEX-FIXtm System Common Name: Screw, Fixation, Bone Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulation Number: 21 CFR 888.3030 Classification: Class II Panel: Orthopedic Product Code: HTN

Indications for Use:

Device Description:

Comparison of Technological Characteristics (Substantial Equivalence):

The primary predicate device: Additional predicate devices:

Smith & Nephew, Inc Biomet Orthopedics, LLC.

K130033 ToggleLoc System (ZipTight Ankle Fixation)

Orthopaedic Implant Company K202971 DRPx Locking Distal Radius Plate System

The OIC FLEX-FIX™ System has the following similarities to those which previously received 510(k) concurrence: · has the same indicated use,

· uses the same operating principle,
· incorporates a very similar design, and
· the additional predicate devices incorporate the same materials
The following differences between the proposed device and the primary predicate were noted:
· The implants for the proposed device are made from titanium alloy while the primary predicate is stainless steel,
· The toggle body is slightly longer (10.8mm) and slightly narrower (2.85mm) than the predicate (10mm x 3.25mm)

Performance Testing:

Dynamic tensile testing and Static testing to failure was performed on the device and a predicate. The device was found to have acceptable mechanical characteristics for the intended uses.

Conclusion:

The OIC FLEX-FIX™ System described in this submission is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.