K Number
K190136
Device Name
Fusion Silastic System
Date Cleared
2019-10-21

(265 days)

Product Code
Regulation Number
888.3720
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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).
More Information

RTS Flexible 1 MPJ Implant W/Grommets (K153609)

No
The document describes a physical implant made of silicone and surgical instruments. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Yes.
The device is intended to alleviate pain, improve function, and stabilize joints in patients with various types of degeneration and deformity.

No

The device is described as a "flexible toe joint prosthesis" and is intended for treatment (e.g., as a spacer augmenting a Keller arthroplasty procedure), not for diagnosing medical conditions.

No

The device description explicitly states it is a collection of flexible toe joint prostheses manufactured from medical grade silicone, which are physical implants.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description: The device is described as a "collection of flexible toe joint prostheses, manufactured from medical grade silicone." These are implants designed to be surgically placed within the body.
  • Intended Use: The intended use describes the device's application in treating degeneration and deformities of toe joints through surgical procedures (Keller arthroplasty, addressing hammertoe). This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.

The information provided clearly indicates that this is a surgically implanted medical device used for treatment, not a diagnostic test.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

KWH

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

first metatarsophalangeal joint, interphalangeal joints

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Sgarlato Flexible Hinge Toe Implant (K905795), Sgarlato Lesser Toe Implant (K884739), ORTHOFLEX: Silicone Hammertoe Implant (K102601)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

RTS Flexible 1 MPJ Implant W/Grommets (K153609)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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

1

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 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.

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 PreparedJanuary 28, 2019
Submitted ByFusion Orthopedics, LLC
4135 S. Power Rd., Suite 110
Mesa, AZ 85212
800-403-6876
Primary ContactEli Jacobson
4135 S. Power Rd., Suite 110
Mesa, AZ 85212
800-403-6876 Tele
e-mail: eli@fusionorthopedics.com
Trade NameFusion Silastic System
Common NameProsthesis, Toe, Constrained, Polymer
ClassII
Product CodeKWH
CFR Section21 CFR Section 888.3720
Device PanelOrthopedic
Primary Predicate
DeviceSgarlato Flexible Hinge Toe Implant (K905795)
Sgarlato Lesser Toe Implant (K884739)
ORTHOFLEX: Silicone Hammertoe Implant (K102601)
Secondary
Predicate DeviceRTS Flexible 1 MPJ Implant W/Grommets (K153609)
Device
DescriptionThe 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).
Indications for
UseThe 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 2.0 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 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 2.0 Implants w/Grommets 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 SHIP Long Implants are intended for patients presenting with the following indications
commonly 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 indications
commonly 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 indications
commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity;
Angular deformity; Impaired function and stability; Pain; Impaired toe length ratio.
MaterialsStainless steel (ASTM F899)
Silicone (ASTM F20242 and ASTM F2038)
Pure Titanium (ASTM F67-13)
Substantial
Equivalence
Claimed to
Predicate DevicesThe Fusion Silastic System is substantially equivalent to the predicate devices in terms of
design, materials used, mechanical safety and performances.
Non-clinical Test
SummaryValidations 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
SummaryNo clinical studies were performed
Conclusions:
Non- clinical and
ClinicalFusion Orthopedics LLC considers the Fusion Silastic System to be equivalent to the
predicate devices listed above. This conclusion is based upon the devices' similarities in
principles of operation, technology, materials and indications for use.

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