The Fusion Medical STI is intended to treat hyperpronated foot, and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion, but blocking excessive pronation and resulting sequela.

Examples are:

Subtalar instability, painful flat foot, congenital flat foot, paralytic flat foot, tarsal coalitions, posterior tibial tendon deformity and flat foot treatment in children and adolescents.

Device Description

The Fusion Medical STI (Subtalar Implant) is a one-piece device made of titanium (6AL-4V ELI) intended to be implanted into the sinus tarsi of the foot. The implant will be available in 5 sizes. 8mm-12mm diameters. The implant that is used in the treatment of excess motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.

AI/ML Overview

This 510(k) submission for the Fusion Medical STI (Subtalar Implant) describes a medical device that aims to be substantially equivalent to a predicate device. This type of submission generally relies on demonstrating equivalence rather than conducting a new, exhaustive clinical study to prove novel efficacy or meet specific performance acceptance criteria with statistical rigor. Therefore, much of the requested information regarding specific acceptance criteria and detailed study data for this particular device as a standalone product may not be present in the provided text.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state specific quantitative acceptance criteria for performance metrics. Instead, it aims to demonstrate substantial equivalence to a predicate device (Futura CSI 510(k) K032902). The "reported device performance" is essentially that it is substantially equivalent to the predicate device in terms of design, material, intended use, and indications.

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Fusion Medical STI)
Material: Titanium 6AL-4V ELI	Meets: Titanium 6AL-4V ELI (Same as predicate)
Use: Single Use	Meets: Single Use (Same as predicate)
Fixation: Screw	Meets: Screw (Same as predicate)
Constraint: Non-Constrained	Meets: Non-Constrained (Same as predicate)
Indications for Use: Treat hyperpronation, stabilize subtalar joint, block displacement of talus, allow normal motion while blocking excessive pronation (including specific examples like congenital flat foot, tarsal coalition, painful flat foot, posterior tibial tendon dysfunction, paralytic flat foot, subtalar instability, foot treatment in adults and children with flat foot).	Meets: Identical indications for use as the predicate device (as per comparison table and Indications for Use statement).
Placement: Sinus tarsi of the foot	Meets: Placed into the sinus tarsi of the foot (Same as predicate).
Functionality: Allow normal subtalar joint motion while blocking excessive pronation.	Meets: Explicitly stated as performing this function, similar to the predicate.
Sizes: Comparable range of sizes	Meets: Available in 5 sizes (8mm-12mm diameters), comparable to predicate's 6 sizes.
Safety: No new materials introduced, made of industry standard materials.	Meets: No new materials, industry standard materials.

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

The provided 510(k) summary does not describe a specific clinical test set or study with a defined sample size for the Fusion Medical STI. This type of submission relies on the existing safety and effectiveness profile of the predicate device, not on new clinical data for the proposed device itself, unless significant differences warrant it. Therefore, there's no mention of sample size, country of origin, or whether it was retrospective or prospective for a new study of the Fusion Medical STI.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Since there is no new clinical study presented for the Fusion Medical STI to establish novel performance or ground truth, this information is not applicable to the provided document. The "ground truth" for demonstrating substantial equivalence rests on the established safety and effectiveness of the predicate device.

4. Adjudication Method for the Test Set

As no specific clinical test set is described, the adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No MRMC comparative effectiveness study is mentioned. This is typically not required for 510(k) submissions unless the device introduces new technology or significantly alters the diagnostic or treatment pathway that would necessitate human reader assessment. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not applicable.

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

The device is a physical implant, not an algorithm or AI. Therefore, a standalone performance study in the context of "algorithm only" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the substantial equivalence claim is effectively the established performance, indications, and safety profile of the legally marketed predicate device (Futura CSI 510(k) K032902). The submission asserts that the Fusion Medical STI is similar enough in design, materials, and intended use that its performance can be inferred to be equivalent to the predicate, which FDA had previously determined to be safe and effective.

8. The Sample Size for the Training Set

There is no mention of a "training set" as this device is a physical implant, not an AI or machine learning model. This concept is not applicable.

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

As there is no training set mentioned, this information is not applicable.

In summary, the provided document is a 510(k) summary for a medical device seeking clearance through substantial equivalence. It does not present data from a new clinical study with explicit acceptance criteria, sample sizes, or ground truth establishment for novel performance. Instead, it meticulously compares the Fusion Medical STI to a legally marketed predicate device, highlighting similarities in design, materials, and intended use to argue for its substantial equivalence.

Summary

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K0817SS

510(K) Summary

Summary of 510(K) safety and effectiveness information upon which the substantial equivalence determination is based:

Prepared:	June 12, 2008
Applicant:	John Riccio (Fusion Medical)
	1663 South Main St
	Waterbury, CT 06706
Telephone:	203-823-8511
Fax:	860-454-7562
Contact:	John Riccio

MAY 20 2009

Device Name:	Subtalar Arthrorisis Implant
Device Trade Name:	STI (Subtalar implant)

Device Classification: Reviewing Panel: Regulation Number: Product Code: Predicate Devices:

Class II Orthopedic 888.3040 87 HWC K031155- Osteomed Subtalar Implant K0322902-(Nexa) Futura Subtalar Implant

Device Description:

Indication for Use:

The Fusion Medical STI (Subtalar Implant) is intended to treat hyperpronation of the foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and resulting sequela.

Example are:

Subtalar instability Painful flat foot Congenital flat foot Paralytic Flat foot

Tarsal Coalitions posterior tibial tendon deformity Flat foot treatment in children and adolescent

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K081755 2/3

Comparison to Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the Futura CSI 510(k) K032902.

Regulatory Class: II 87 HWC Product Code:

Table 1. Comparison of Fusion Medical STI and Futura Biomedical Subtalar Implant

Item	Fusion	Futura
Product Name:	STI Subtalar Implant	Subtalar Arthrorisis Implant
Use:	Single Use	Single Use
Fixation:	Screw	Screw
Constraint:	Non Constrained	Non Constrained
Material:	Titanium 6AL-4V ELI	Titanium 6AL-4V ELI
Sizes:	5	6
Indications	The Fusion Medical STIimplant is intended to treathyperpronated foot and stabilizethe subtalar joint. It is intended totreat forward, downward and medialdisplacement of the talus, thusallowing normal subtalar jointmotion but blocking excessivepronaton and resulting in sequela.	The Futura Subtalar arthrorisis implantis intended to treat hyreppronated foot andstabilize the subtalar joint. It is intended toforward, downward and medial displacementof the talus, thus allowing normal subtalar jointmotion, but blocking excessive pronation andresulting in sequela.
	Examples Include:
	Congenital flat foot	Congenital flat foot
	Tarsal coalition	Tarsal coalition
	Painful flat foot	Painful flat foot
	Posterior tibial tendon dysfunction	Posterior tibila tendon dysfunction
	Paralytic flat foot.	Paralytic flat foot
	Subtalar instability	Subtalar instability
	Foot treatment of adult and children(Flat Foot)	Foot treatment of adult and children(Flat Foot)

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K081755 3/3

Similarities of the Fusion Medical STI (Subtalar Implant) and Nexas Futura CSI Implant include the following:

Both devices are intended for surgical implantation longer than 30 days. No new materials are introduced in either product. Both devices are made of industry standard materials. Both devices are placed into the sinus tarsi of the foot, allowing normal subtalar joint motion while blocking excessive pronaton and resulting in sequela. Both devices are similar in size; They have the same indications of use.

Summary:

The Fusion Medical STI and the (Nexa) Future CSI, have the same indications of use. The design of the STI (Fusion Medical) and The CSI (Nexa) are comparable. The New Fusion Medical STI implant is substantially equivalent to the predicate device currently on the market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

MAY 20 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fusion Medical % Mr. John Riccio 1663 South Main Street Waterbury, Connecticut 06706

Re: K081755

Trade/Device Name: Fusion Medical STI System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 4, 2009 Received: May 4, 2009

Dear Mr. Riccio:

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. The The 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.

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at

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Page 2 - Mr. John Riccio

(240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative تر and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K081755

Device Name: Fusion Medical STI System

Indications for Use:

Examples are:

Subtalar instability, painful flat foot, congenital flat foot, paralytic flat foot, tarsal coalitions, posterior tibial tendon deformity and flat foot treatment in children and adolescents.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Onuta 2 Pts
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K081755

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.