SUBTALAR ARTHRORISIS IMPLANT

K032902 · Nexa Orthopedics, Inc. · HWC · Dec 15, 2003 · Orthopedic

Device Facts

• Record ID: K032902
• Device Name: SUBTALAR ARTHRORISIS IMPLANT
• Applicant: Nexa Orthopedics, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Dec 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

The Futura Biomedical Subtalar Arthrorisis Implant is a single-piece titanium (6AL-4V ELI) device surgically implanted into the sinus tarsi of the foot. It functions as a mechanical spacer to maintain joint space and limit excessive pronation of the talus relative to the calcaneus while preserving normal subtalar joint motion. The device is available in six sizes and is intended for long-term implantation (exceeding 50 days). It is used by orthopedic surgeons to treat various flat foot conditions and subtalar instability. By blocking forward, downward, and medial displacement of the talus, the implant stabilizes the joint and prevents the sequelae associated with excessive pronation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

One-piece implant; material: Titanium 6AL-4V ELI; fixation: screw; constraint: non-constrained; dimensions: 6 sizes; intended for long-term implantation (>50 days); single-use; sterile.

Indications for Use

Indicated for children and adolescents with hyperpronated foot, congenital flat foot, painful flat foot, tarsal coalitions, posterior tibial tendon dysfunction, paralytic flat foot, subtalar instability, or those who have failed long-term orthopaedic treatment (shoes, insoles).

Regulatory Classification

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.

Predicate Devices

• New Deal Kalix Implant (K001231)

Submission Summary (Full Text)

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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: [phone] 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:

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.

#### 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

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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 Arthrorisis<br>Implant is intended to treat<br>hyperpronated foot and stabilize the<br>subtalar joint. It is intended to block<br>forward, downward and medial<br>displacement of the talus, thus<br>allowing normal subtalar joint<br>motion but blocking excessive<br>pronation and the resulting sequela.<br>Examples include: | The New Deal Kalix implant is<br>intended to treat hyperpronated foot<br>and stabilize the subtalar joint. It is<br>intended to block forward, downward<br>and medial displacement of the talus,<br>thus allowing normal subtalar joint<br>motion but blocking excessive<br>pronation and the resulting sequela.<br>Examples include: |
| | Flat foot treatment in<br>children and adolescents | Flat foot treatment in<br>children and adolescents |
| | Congenital flat foot | Congenital flat foot |
| | Unsuccessful long term<br>orthopaedic treatment<br>(shoes, insoles...) | Unsuccessful long term<br>orthopaedic treatment (shoes,<br>insoles...) |
| | Tarsal coalitions | Tarsal coalitions |
| | Painful flat foot | Painful flat foot |
| | Supple deformity in<br>posterior tibial tendon<br>dysfunction | Supple deformity in posterior<br>tibial 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 [phone]. 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 [phone] or [phone] 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:

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

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

for Mark N. Millerson

of General tetorative curological De rices

K032902