The GEO 1st MTP Joint Arthrodesis Plating System is indicated for use in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonunion or revision surgery.

Device Description

The GEO 188 MTP Joint Arthrodesis Plating System consists of anatomically contoured, low- profile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. All screws are offered in lengths of 10-40mm. The system also includes associated instrumentation consisting of plate tacks, quide-wire, drill bit, drill bit, drill guides (locking and non-locking), AO driver tip, reamers, depth gauge, non-locking drill guide handle, AO driver handle, and templates for plate and reamer sizing. All GEO 1ª MTP Joint Arthrodesis Plating System components (implants and instruments) are provided sterile and for single use only.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "GEO 1st MTP Joint Arthrodesis Plating System." As such, it describes a mechanical device for internal fixation of bones, not a software algorithm or AI-powered diagnostic tool. Therefore, the questions related to AI/algorithm performance, such as sample size for test sets, expert ground truth, MRMC studies, standalone performance, and training sets, are not applicable to the content provided.

The performance data section for this type of device focuses on physical and mechanical testing to ensure its safety and effectiveness when used for bone fixation.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
In accordance with ASTM F382-17-17 Standard Specification and Test Methods for Metallic Bone Plates	Performance testing demonstrated substantial equivalence to the predicate device.
In accordance with ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws	Performance testing demonstrated substantial equivalence to the predicate device.

Note: The document highlights compliance with these standards and concludes substantial equivalence, implying the device met the performance requirements outlined in these standards. Specific numerical results or pass/fail thresholds against explicit acceptance criteria are not detailed in this summary document.

2. Sample size used for the test set and the data provenance

Not applicable for this type of mechanical device testing. The testing would involve physical samples of the plates and screws, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for a mechanical device is established through physical and mechanical testing against recognized standards.

4. Adjudication method for the test set

Not applicable. Mechanical testing is typically objectively measured against established engineering standards.

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, as this is a mechanical bone fixation device, not an AI or diagnostic imaging device.

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

Not applicable, as this is a mechanical bone fixation device, not an algorithm.

7. The type of ground truth used

For a mechanical device, the "ground truth" is typically defined by the established performance requirements and specifications outlined in the referenced ASTM standards (ASTM F382-17-17 and ASTM F543-17). These standards detail specific tests (e.g., bending strength, fatigue, pull-out strength for screws) and criteria that the device must meet.

8. The sample size for the training set

Not applicable, as this is a mechanical bone fixation device, not an AI or machine learning model that requires a training set.

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

Not applicable.

Summary

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March 26, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Gramercy Extremity Orthopedics, LLC Michael P. Simpson CEO 1239 N Glenville Dr. Richardson, Texas 75081

Re: K200108

Trade/Device Name: GEO 1st MTP Joint Arthrodesis Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: January 10, 2020 Received: January 17, 2020

Dear Michael Simpson:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 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).

Sincerely,

Shumaya Ali, M.P.H. 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) K200108

Device Name GEO 1st MTP Joint Arthrodesis Plating System

Indications for Use (Describe)

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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Image /page/3/Picture/1 description: The image shows the logo for Gramercy Extremity Orthopedics. The logo has the letters GEO in green, yellow, and purple. Below the letters is the text "GRAMERCY EXTREMITY ORTHOPEDICS" in gray and black.

Submitted by/Sponsor:	Gramercy ExtremityOrthopedics, LLC.840 F. Avenue #104Richardson, TX 75081USA 972-908-9808	Contact Person:
Date Prepared:	March 24, 2020
Trade Name:	GEO 1st MTP Joint Arthrodesis Plating System
Common Name:	Plate, Fixation, Bone
Classification CodeName & Reference:	HRS, HWC	Plate, Fixation, Bone
	21 CFR §888.3030	Single/multiple component metallic bone fixationappliances and accessories.
Predicate Devices	K041287: Vilex Plating System

GEO 1st MTP Joint Arthrodesis Plating System 510(k) Summary

Device Description:

Indications for Use:

Technological Characteristics: The GEO 1* MTP plate and screw implants are comprised of titanium alloy Ti-6Al-4V conforming to ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. All patient contacting components are comprised of biocompatible materials. All System components are provided sterile by gamma radiation and are disposable, for single-use only.

Comparison to Predicate

The GEO 1st MTP Joint Arthrodesis Plating System compares favorably to the intended use is the same as that of the predicate, both are anatomically contoured for the 1 metatarsal phalangeal joint, comprised of the same material, utilize locking and non-locking screws, and adhere to the same testing standards. There are minor technological differences between the subject and predicate devices. The hole location and configuration is slightly different, and overall length range of the subject plates is slightly shorter than that of the predicate. The subject plates are offered in 0° and 5° of dorsifiexion/abduction whereas the predicate also offers 10°. The thickness of both subject and predicate plates is the subject plate is slightly thicker at the joint for added strength. The screw diameter offerings of the subject device are slightly different but within the range of the predicate. The GEO subject device is offered sterile, individually packaged whereas the subject device is provided non-sterile, requiring user performed cleaning and sterlization. These differences are considered to be minor and results of performance testing supports substantial equivalence.

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Image /page/4/Picture/0 description: The image contains the logo for Gramercy Extremity Orthopedics. The logo features the letters 'GEO' in different colors, with 'G' in green, 'E' in yellow, and 'O' in purple. Below the letters, the words 'GRAMERCY EXTREMITY ORTHOPEDICS' are written in black, with 'GRAMERCY' and 'EXTREMITY' on one line and 'ORTHOPEDICS' on the line below.

Substantial Equivalence: The GEO 1* MTP Joint Arthrodesis Plating System is substantially equivalent to the Vilex Plating System cleared under K041287. The GEO 1ª MTP Joint Arthrodesis Plating System has the same intended use and material as the predicate and the minor technological differences in plate and screw geometry (overall plate and screw lengths, plate hole placement/configuration, and overall screw lengths as described above) are not considered to raise new questions of safety or effectiveness.

Performance Data

Performance testing was performed on the GEO 1* MTP Joint Arthrodesis Plating System plates and screws in accordance with ASTM F382-17-17 Standard Specification and Test Methods for Metallic Bone Plates, and ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws. The results of performance testing demonstrate the GEO 15 MTP Joint Arthrodesis Plating System to be substantially equivalent to the predicate device.

Conclusion

The GEO 1ª MTP Joint Arthrodesis Plating System is considered to be substantially equivalent to the predicate device. This conclusion is based on the similarities in principles of operation, technology, materials and intended use.

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.