The Futura Biomedical Arthrorisis Implant 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 the resulting sequela. Examples include: Flat foot treatment in children and adolescents Congenital flat foot Unsuccessful long term orthopaedic treatment (shoes, insoles ...) Tarsal coalitions Painful flat foot Supple deformity in posterior tibial tendon dysfunction Paralytic flat foot Subtalar instability

Device Description

The Futura Biomedical 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 is designed in 6 sizes. The implant which is used in the treatment of excessive 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

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document is a 510(k) premarket notification for a medical device (Subtalar Arthrorisis Implant). The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically focuses on comparing the new device's design, materials, indications for use, and performance characteristics to a predicate device, rather than performing de novo clinical trials to establish new safety and effectiveness criteria.

As such, the information provided does not contain details about specific acceptance criteria or an independent study to prove the device meets new acceptance criteria beyond equivalence to the predicate device. Instead, it focuses on demonstrating substantial equivalence to an existing, legally marketed device.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from a de novo efficacy study)	Reported Device Performance (from a de novo efficacy study)
Not applicable - This submission aims for substantial equivalence, not to establish new performance criteria.	Not applicable - Performance is implicitly "equivalent" to the predicate device.

The document explicitly states: "The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device."

However, we can infer the comparison points that serve as the basis for demonstrating equivalence to the predicate device, which are presented in the "Comparison to Predicate Device" table (Table 1). These are not 'acceptance criteria' in the traditional sense of a specific performance metric to be met by the new device in an independent study, but rather aspects that must be sufficiently similar to the predicate to establish equivalence.

Inferred Comparison Points (from Table 1, used to establish equivalence):

Item	Futura Product (Reported Characteristics)	New Deal Product (Predicate Characteristics)	Equivalence Assessment
Product Name	Subtalar Arthrorisis Implant	Subtalar Arthrorisiss Implant	Similar
Use	Single use	Single use	Equivalent
Fixation	Screw	Screw	Equivalent
Constraint	Non constrained	non constrained	Equivalent
Material	Titanium 6AL-4V ELI	Titanium alloy and UHMWPE	Difference noted (Titanium vs. Titanium alloy and UHMWPE) However, the summary states "both devices are made of industry standard materials, no new materials are introduced in either device." This implies the material difference is not considered a barrier to equivalence for this submission.
Sizes	6 sizes	5 sizes	Similar (range of sizes provided)
Indications for use	Intended to treat hyperpronated foot and stabilize the subtalar joint. Block forward, downward and medial displacement of the talus, allowing normal subtalar joint motion but blocking excessive pronation. Examples include: Flat foot treatment in children and adolescents, Congenital flat foot, Unsuccessful long term orthopaedic treatment, Tarsal coalitions, Painful flat foot, Supple deformity in posterior tibial tendon dysfunction, Paralytic flat foot, Subtalar instability.	Identical indications for use as Futura product.	Identical

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

Not applicable. No independent "test set" (i.e., patient data from a clinical trial or study for the Futura device) is mentioned or used to establish new acceptance criteria. The submission relies on a comparison to the predicate device.

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

Not applicable. No ground truth for an independent test set for the Futura device is established or described. The "ground truth" for the predicate device would be its prior regulatory clearance and market history, implicitly approved by regulatory bodies and deemed safe and effective for its indicated uses.

4. Adjudication method for the test set

Not applicable. There is no test set for clinical performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is irrelevant.

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

Not applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used

Substantial Equivalence to a Predicate Device. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed New Deal Kalix Implant, which serves as the predicate device. The Futura device demonstrates equivalence to this predicate through comparison of design, materials, and intended use as described in the summary.

8. The sample size for the training set

Not applicable. This submission is for a physical implant and does not involve a "training set" in the context of machine learning or AI models.

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

Not applicable. No training set is mentioned or relevant for this type of device submission.

Summary

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DEC 1 5 2003

K032902

PAGE 1 of 3

510 (k) Summary

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

September 13, 2003 Prepared:

Futura Biomedical Applicant: 990 Park Center Drive Vista, CA 92081

760-599-1670 Telephone: 760-599-1675 Fax: Louise M. Focht Contact:

Subtalar Arthrorisis Implant Device Name: Subtalar Arthrorisis Implant Device Trade Name: Class II Device Classification: Orthopedic Reviewing Panel: 888.3040 Regulation Number 87 HWC Product Code: K001231 - The New Deal Kalix Implant Predicate Device: 2030833 Registration Number: 9028319 Owner Operator Number:

Device Description:

Indications for Use:

The Futura Biomedical Arthrorisis Implant is intended to treat hyperpronated foot and stabalize 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 the resulting sequela. Examples include:

Flat foot treatment in children and adolescents

{1}------------------------------------------------

Congenital flat foot Unsuccessful long term orthopaedic treatment (shoes, insoles ... ) Tarsal coalitions Painful flat foot Supple deformity in posterior tibial tendon dysfunction Paralytic flat foot Subtalar instability

Comparison to Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the New Deal Kalix Implant.

Regulatory Class: II 87 KXE Product Code:

Table 1. Comparison of Futura Biomedical and New Deal Kalix Implant

Item	Futura Product	New Deal Product
Product Name	Subtalar Arthrorisis Implant	Subtalar Arthrorisiss Implant
Use	Single use	Single use
Fixation	Screw	Screw
Constraint	Non constrained	non constrained
Material	Titanium 6AL-4V ELI	Titanium alloy and UHMWPE
Sizes	6 sizes	5 sizes
Indications for use	The Futura Biomedical ArthrorisisImplant is intended to treathyperpronated foot and stabilize thesubtalar joint. It is intended to blockforward, downward and medialdisplacement of the talus, thusallowing normal subtalar jointmotion but blocking excessivepronation and the resulting sequela.Examples include:	The New Deal Kalix implant isintended to treat hyperpronated footand stabilize the subtalar joint. It isintended to block forward, downwardand medial displacement of the talus,thus allowing normal subtalar jointmotion but blocking excessivepronation and the resulting sequela.Examples include:
	Flat foot treatment inchildren and adolescents	Flat foot treatment inchildren and adolescents
	Congenital flat foot	Congenital flat foot
	Unsuccessful long termorthopaedic treatment(shoes, insoles...)	Unsuccessful long termorthopaedic treatment (shoes,insoles...)
	Tarsal coalitions	Tarsal coalitions
	Painful flat foot	Painful flat foot
	Supple deformity inposterior tibial tendondysfunction	Supple deformity in posteriortibial tendon dysfunction
	Paralytic flat foot	Paralytic flat foot
	Subtalar instability	Subtalar instability

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Kc32902 PAGE 3 of 3

Similarities of the Futura Biomedical Subtalar Arthrorisis Implant and the New Deal Kalix Implant include:

Both devices are: intended for single use only; intended for surgical implantation longer Bour de rioes are mices are placed into the sinus tarsi of the foot, allowing normal than 50 days, '60dr doviete are piess ve pronaton and resulting sequela; both Subtain John mode of industry standard materials, no new materials are introduced in either devices are mude of measa , baarably sized; both devices have the same indications for use.

Summary:

The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the branches of government. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Public Health Service

DEC 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Louise M. Focht Futura Biomedical 990 Park Center Drive, Suite H Vista, California 92081

Re: K032902

Trade/Device Name: Subtalar Arthrorisis Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 16, 2003 Received: September 17, 2003

Dear Ms. Focht:

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 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 such 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); 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.

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Page 2 - Ms. Louise M. Focht

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Mulkeran

Celia M. Witten, Ph.D., M.D. Director

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

Enclosure

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KO32902 510 (k) Number (If Known): Device Name: Subtalar Arthrorisis Implant

Indications for Use:

Flat foot treatment in children and adolescents Congenital flat foot Unsuccessful long term orthopaedic treatment (shoes, insoles ...) Tarsal coalitions Painful flat foot Supple deformity in posterior tibial tendon dysfunction Paralytic flat foot Subtalar instability

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*Labels: **Value: **

STOR Neurologuesi Devices Ausision of Concent. Restorative (पुगु-गहिए एकाडार)

for Mark N. Millerson

of General tetorative curological De rices

K032902

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.