Vector Hammertoe Correction System

K201850 · Nvision Biomedical Technologies, Inc. · HWC · Aug 4, 2020 · Orthopedic

Device Facts

• Record ID: K201850
• Device Name: Vector Hammertoe Correction System
• Applicant: Nvision Biomedical Technologies, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Aug 4, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Device Story

The Vector Hammertoe Correction System is a bone fixation implant system used by orthopedic surgeons for lesser toe reconstruction. The system consists of PEEK (polyetheretherketone) implants coated with hydroxyapatite (HA), available in various diameters (3.0mm, 3.5mm, 4.0mm) and configurations (cannulated and non-cannulated). The system includes associated surgical instrumentation such as K-wires, drills, taps, sizers, and inserters. During surgery, the physician uses these instruments to prepare the bone and insert the fixation device to stabilize osteotomies. The device provides mechanical fixation to facilitate bone healing and correct toe deformities. It is intended for use in a clinical or surgical setting.

Clinical Evidence

No clinical data. Substantial equivalence is supported by engineering analysis of mechanical performance characteristics compared to predicate devices.

Technological Characteristics

Implants are constructed from PEEK (polyetheretherketone) with hydroxyapatite (HA) coating. Instrumentation is manufactured from medical-grade stainless steel. The system is a bone fixation fastener (21 CFR 888.3040). It is a sterile, implantable device available in cannulated and non-cannulated configurations.

Indications for Use

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

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

• VECTOR Hammertoe Correction System (K183055)
• Fusion Orthopedics HammerTech Fixation System (K161449)
• Extremity Medical HammerFIX Device (K133636)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Nvision Biomedical Technologies, Inc Analaura Villarreal Berain Extremity Project Engineer 4590 Lockhill Selma San Antonio, Texas 78249

Re: K201850

Trade/Device Name: Vector Hammertoe Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 26, 2020 Received: July 6, 2020

Dear Analaura Berain:

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 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

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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 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.

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K201850

#### Device Name

VECTOR Hammertoe Correction System

Indications for Use (Describe)

The Vector Hammertoe Correction System is indicated 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) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| <table><tr><td><div style="display:inline-block;"> <input checked="true" type="checkbox"/> Research Use (incl. CER-201 Cohort Biobank)</div></td></tr><tr><td><div style="display:inline-block;"> <input type="checkbox"/> On-Treatment Use (incl. CER-201 On-Treatment)</div></td></tr></table> | <div style="display:inline-block;"> <input checked="true" type="checkbox"/> Research Use (incl. CER-201 Cohort Biobank)</div> | <div style="display:inline-block;"> <input type="checkbox"/> On-Treatment Use (incl. CER-201 On-Treatment)</div> |
| <div style="display:inline-block;"> <input checked="true" type="checkbox"/> Research Use (incl. CER-201 Cohort Biobank)</div> | | |
| <div style="display:inline-block;"> <input type="checkbox"/> On-Treatment Use (incl. CER-201 On-Treatment)</div> | | |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for NVision biomedical technologies. The logo features a stylized "N" with a series of short, parallel lines extending from its left side, resembling a DNA sequence. Below the "NVISION" text is the phrase "biomedical technologies" in a smaller, italicized font.

## K201850

# 510(k) Summary

DATE PREPARED

May 26, 2020

#### MANUFACTURER AND 510(k) OWNER

Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249, USA Telephone: [phone] Fax: [phone] Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance

#### REPRESENTATIVE

Analaura Villarreal Berain, Extremity Project Engineer Nvision Biomedical Technologies Telephone: [phone] ext. 109 Email: [e-mail]

### PROPRIETARY NAME OF SUBJECT DEVICE

VECTOR™ Hammertoe Correction System

COMMON NAME Bone Fixation Screw System

#### DEVICE CLASSIFICATION

Smooth or threaded metallic bone fixation fastener (Classification Regulations: 21 CFR 888.3040, Product Codes: HWC, Class: II)

#### PREMARKET REVIEW

Orthopedic Devices

#### INDICATIONS FOR USE

The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

#### DEVICE DESCRIPTION

The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.0mm (cannulated), Ø3.50mm (cannulated and non-cannulated) and Ø4.00mm (cannulated and non-cannulated) and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

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Image /page/4/Picture/0 description: The image shows the logo for Nvision biomedical technologies. The logo features the letter N with a series of horizontal lines to the left of it. The words "biomedical technologies" are written in a smaller font below the main logo.

### PREDICATE DEVICE IDENTIFICATION

The subject Vector Hammertoe Correction System is substantially equivalent to the following predicates:

| 510(k) Number | Predicate Device Name / Manufacturer | Primary<br>Predicate |
|---------------|---------------------------------------------------|----------------------|
| K183055 | VECTOR TM Hammertoe Correction System | ✓ |
| K161449 | Fusion Orthopedics HammerTech Fixation System | |
| K133636 | Extremity Medical HammerFIX Device | |

### SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the Vector Hammertoe Correction System. The following was performed to demonstrate safety per methods of the previous submission:

- . Engineering Analysis comparison of mechanical performance characteristics
The results of this engineering analysis indicate that the Vector Hammertoe Correction System is substantially equivalent to the predicate devices.

### EQUIVALENCE TO PREDICATE DEVICES

Nvision believes that the Vector Hammertoe Correction System modification is substantially equivalent to the predicate devices. The subject implants maintain the same features as the previously cleared devices but add new diameter, length and cannulated options that are within the range of the predicates. This modification does not change the intended use or performance of the device and does not raise additional questions of substantial equivalence. These technological characteristics have undergone engineering analysis to ensure the device is as safe and effective as the predicates.

#### CONCLUSION

Based on the engineering analysis of device characteristics, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Vector Hammertoe Correction System options are assessed to be substantially equivalent to the predicate devices.