The GAIT Implants are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.
The GAIT 2.0 Implants are intents presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT 2.0 Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.
The SHIP Long Implants, are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.
The Shaw Rod Implant is intended for patients presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impared function and stability; Pain; Impaired toe length ratio.
The SHIP Short Implants are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.

Device Description

The Fusion Silastic System consists of a collection of flexible toe joint prostheses, manufactured from medical grade silicone (ASTM F2042). The product family is offered in five configurations to address varying indications and patient anatomy; the Gait Implant, the Gait 2.0 Implant, the SHIP Long Implant, the SHIP Short Implant and the Shaw Rod. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899).

AI/ML Overview

This document is a 510(k) premarket notification for the Fusion Silastic System, a toe joint prosthesis. It outlines the company's claim of substantial equivalence to predicate devices.

Based on the provided document, there is NO information about acceptance criteria or a study proving that an AI-driven device meets acceptance criteria.

The document is for a physical medical device (toe joint prosthesis) and does not describe any AI component or a study to evaluate AI performance. The "Non-clinical Test Summary" and "Clinical Test Summary" explicitly state:

Non-clinical Test Summary: "Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering rational was performed to show performance equivalence. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified above."
Clinical Test Summary: "No clinical studies were performed."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria because the provided text describes a physical implant and its regulatory clearance process, not an AI-powered device.

Summary

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Image /page/0/Picture/0 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.

October 21, 2019

Fusion Orthopedics, LLC Eli Jacobson Official Correspondent 4135 S. Power Rd., Suite 110 Mesa, Arizona 85212

Re: K190136

Trade/Device Name: Fusion Silastic System Regulation Number: 21 CFR 888.3720 Regulation Name: Toe joint polymer constrained prosthesis Regulatory Class: Class II Product Code: KWH Dated: September 18, 2019 Received: September 20, 2019

Dear Eli Jacobson:

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,

For Ting Song Acting 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) K190136

Device Name

Fusion Silastic System

Indications for Use (Describe)

The GAIT Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.

The GAIT 2.0 Implants are intents presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.

The GAIT 2.0 Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.

The SHIP Long Implants, are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.

The Shaw Rod Implant is intended for patients presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impared function and stability; Pain; Impaired toe length ratio.

The SHIP Short Implants are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Date Prepared	January 28, 2019
Submitted By	Fusion Orthopedics, LLC4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876
Primary Contact	Eli Jacobson4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876 Telee-mail: eli@fusionorthopedics.com
Trade Name	Fusion Silastic System
Common Name	Prosthesis, Toe, Constrained, Polymer
Class	II
Product Code	KWH
CFR Section	21 CFR Section 888.3720
Device Panel	Orthopedic
Primary PredicateDevice	Sgarlato Flexible Hinge Toe Implant (K905795)Sgarlato Lesser Toe Implant (K884739)ORTHOFLEX: Silicone Hammertoe Implant (K102601)
SecondaryPredicate Device	RTS Flexible 1 MPJ Implant W/Grommets (K153609)
DeviceDescription	The Fusion Silastic System consists of a collection of flexible toe joint prostheses,manufactured from medical grade silicone (ASTM F2042). The product family is offered infive configurations to address varying indications and patient anatomy; the Gait Implant, theGait 2.0 Implant, the SHIP Long Implant, the SHIP Short Implant and the Shaw Rod. Thespecialized instruments are made primarily of surgical grade stainless steel (ASTM F899).
Indications forUse	The GAIT Implants are intended for patients presenting with class 3 degeneration of the firstmetatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spurring surrounding the joint space, and a painful range of motion of the firstmetatarsophalangeal joint both with rotation and with walking. This application is notexpected to recreate a normal range of motion of the first metatarsophalangeal joint. TheGAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing thehallux to the first metatarsal.The GAIT 2.0 Implants are intended for patients presenting with class 3 degeneration of thefirst metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bonyspur ring surrounding the joint space, and a painful range of motion of the firstmetatarsophalangeal joint both with rotation and with walking. This application is notexpected to recreate a normal range of motion of the first metatarsophalangeal joint. TheGAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing thehallux to the first metatarsal.
	The GAIT Implants w/Grommets are intended for patients presenting with class 3degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss ofjoint cartilage, bony spur ring surrounding the joint space, and a painful range of motion ofthe first metatarsophalangeal joint both with rotation and with walking. This application is notexpected to recreate a normal range of motion of the first metatarsophalangeal joint. TheGAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing thehallux to the first metatarsal.
	The GAIT 2.0 Implants w/Grommets are intended for patients presenting with class 3degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss ofjoint cartilage, bony spur ring surrounding the joint space, and a painful range of motion ofthe first metatarsophalangeal joint both with rotation and with walking. This application is notexpected to recreate a normal range of motion of the first metatarsophalangeal joint. TheGAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing thehallux to the first metatarsal.
	The SHIP Long Implants are intended for patients presenting with the following indicationscommonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity;Angular deformity; Impaired function and stability; Pain; Impaired toe length ratio.
	The Shaw Rod Implants are intended for patients presenting with the following indicationscommonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity;Angular deformity; Impaired function and stability; Pain; Impaired toe length ratio.
	The SHIP Short Implants are intended for patients presenting with the following indicationscommonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity;Angular deformity; Impaired function and stability; Pain; Impaired toe length ratio.
Materials	Stainless steel (ASTM F899)Silicone (ASTM F20242 and ASTM F2038)Pure Titanium (ASTM F67-13)
SubstantialEquivalenceClaimed toPredicate Devices	The Fusion Silastic System is substantially equivalent to the predicate devices in terms ofdesign, materials used, mechanical safety and performances.
Non-clinical TestSummary	Validations were performed on the cleaning, packaging and sterilization of the implants andassociated surgical instruments. Engineering rational was performed to show performanceequivalence. The results of the testing demonstrate that the device is substantiallyequivalent to the predicate device identified above.
Clinical TestSummary	No clinical studies were performed
Conclusions:Non- clinical andClinical	Fusion Orthopedics LLC considers the Fusion Silastic System to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices' similarities inprinciples of operation, technology, materials and indications for use.

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Regulation Number and Section

§ 888.3720 Toe joint polymer constrained prosthesis.

(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.