Interphalangeal Joint Fusion Device Range

K191424 · Neosteo · HWC · Aug 28, 2019 · Orthopedic

Device Facts

• Record ID: K191424
• Device Name: Interphalangeal Joint Fusion Device Range
• Applicant: Neosteo
• Product Code: HWC · Orthopedic
• Decision Date: Aug 28, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Interphalangeal Joint Fusion Devices are intended for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

Device Story

Interphalangeal Joint Fusion Device Range consists of metallic implants designed to stabilize two bone fragments to facilitate bone fusion. Implants are available in various lengths and angulations. Used by surgeons in clinical settings for lesser toe reconstruction procedures (hammertoe, claw toe, mallet toe). Implants provide mechanical fixation of bone fragments during the healing process, aiding in structural alignment and patient recovery.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical mechanical bench testing, including static bending, dynamic bending, and axial pull-out tests.

Technological Characteristics

Metallic bone fixation fasteners made of titanium alloy per ISO 5832-3 / ASTM F136. Available in multiple lengths and angulations. Provided sterile.

Indications for Use

Indicated for patients requiring fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

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

• HammerFix® (K133636)
• ProToe® (K101165)
• Kirschner and Guide Wires (K100736)

Submission Summary (Full Text)

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August 28, 2019

Neosteo % Mr. J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 4314 W. 3800 S. West Haven, Utah 84401

Re: K191424

Trade/Device Name: Interphalangeal Joint Fusion Device Range Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 8, 2019 Received: August 12, 2019

Dear Mr. Webb:

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

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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 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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for RPJ

Ronald Jean, Ph.D. Assistant Director DHT6B: Division of Spinal 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) K191424

### Device Name

Interphalangeal Joint Fusion Device Range

### Indications for Use (Describe)

The Interphalangeal Joint Fusion Devices are intended for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------|
| ly Prescription Use (Part 21 CFR 801 Subpart D) | _ Over-The-Counter Use (21 CFR 801 Subp |

lion 300 (Part 21 SFR 301 Support B)

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

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# 510(k) Summary

#### l. SUBMITTER'S INFORMATION

## A. 510(k) Owner

NEOSTEO Mallève 2A 1 Boulevard Jean Moulin 44 100 Nantes, France Tel: [phone] Fax: [phone]

## B. Contact Person

JD Webb The Orthomedix Group, Inc. 4314 W. 3800 S. West Haven, UT 84401 Tel: [phone] Email: [e-mail]

# C. Date of Preparation of the 510(k) Summary

8th August 2019

### DEVICE IDENTIFICATION II.

| Trade or proprietary name | Interphalangeal Joint Fusion Device Range |
|-----------------------------|---------------------------------------------------------------------------|
| Common or usual name | Interphalangeal Joint Fusion Device Range |
| Classification regulation | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Proposed Regulatory Class | Class II |
| Panel | 87 "Orthopedic" |
| Product code | HWC |
| Primary Predicate Device | HammerFix® (K133636) from Extremity Medical |
| | ProToe® (K101165) from Wright Medical |
| Secondary Predicate Devices | Kirschner and Guide Wires (K100736) from SMT Schilling Metalltechnik GmbH |

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Image /page/4/Picture/1 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller font.

# 510(k) Summary

#### III. DEVICE DESCRIPTION

The Interphalangeal Joint Fusion Device Range consists of metallic devices intended to stabilize two bone fragments until bone fusion. They are available in several lengths and angulations. All the implants are made of titanium alloy.

## A. Materials

Titanium alloy per ISO 5832-3 / ASTM F136.

#### IV. INDICATIONS FOR USE

The Interphalangeal Joint Fusion Devices are intended for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

| Intended Use | The Interphalangeal Joint Fusion Devices and all the predicates have<br>similar intended uses. |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | The Interphalangeal Joint Fusion Devices are fabricated of the same<br>material as the predicate devices. |
| Design<br>Features/Functions | The Interphalangeal Joint Fusion Devices and the cited predicate<br>devices share similar basic design features and functions. |
| Dimensions | The Interphalangeal Joint Fusion Devices are dimensionally similar to the<br>cited predicate devices. |
| Sterilization | The Interphalangeal Joint Fusion Devices are provided sterile as are the<br>cited predicate devices. |
| Performance<br>Specification | Mechanical testing confirmed the Interphalangeal Joint Fusion Devices<br>demonstrated as good or better performances than the cited predicate<br>devices under the same test conditions. |

### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS / SUBSTANTIAL EQUIVALENCE V.

#### VI. NON-CLINICAL TEST SUMMARY

The following mechanical tests were performed:

- o Static bending test
- o Dynamic bending test

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Image /page/5/Picture/1 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller, lighter font.

# 510(k) Summary

# o Axial pull-out test

The results of these tests indicate that the Interphalangeal Joint Fusion Devices are as strong or stronger than predicate devices.

### CLINICAL TEST SUMMARY VII.

No clinical studies were performed.

### CONCLUSIONS NON-CLINICAL AND CLINICAL VIII.

NEOSTEO considers the Interphalangeal Joint Fusion Devices to be equivalent to the predicate devices listed above. This conclusion is based on the devices' similarities in principles of operation, technology, materials and indications for use.