SnapHammer Hammertoe Correction System

K231453 · Nvision Biomedical Technologies, Inc. · HWC · Feb 16, 2024 · Orthopedic

Device Facts

• Record ID: K231453
• Device Name: SnapHammer Hammertoe Correction System
• Applicant: Nvision Biomedical Technologies, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Feb 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SnapHammer 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. Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

Device Story

SnapHammer Hammertoe Correction System consists of additively manufactured titanium fixation implants with snap-off posts; system includes stainless steel drills, inserters, and sizers. Used by orthopedic surgeons in clinical/surgical settings for hammertoe, claw toe, and mallet toe reconstruction. Surgeon inserts implant into bone; snap-off post facilitates quick insertion and is removed after threading. Provides mechanical fixation of osteotomies; stabilizes lesser toe joints. Benefits patient through stable bone fixation during healing process.

Clinical Evidence

Bench testing only. Mechanical performance testing included torsion, driving torque, and axial pullout per ASTM F543, plus static and dynamic bending. Additive manufacturing validation included tensile testing per ASTM F3001 and residual powder removal analysis per ASTM F1877.

Technological Characteristics

Titanium fixation device (additively manufactured); stainless steel instrumentation (drills, inserters, sizers). Diameters: 3.0mm and 3.50mm; lengths from 12mm. Mechanical fixation via threaded implant with snap-off post. Standards: ASTM F543 (mechanical), ASTM F3001 (tensile), ASTM F1877 (particle analysis).

Indications for Use

Indicated for fixation of osteotomies and reconstruction of lesser toes (hammertoe, claw toe, mallet toe) in patients requiring surgical correction. Cannulated implants allow use with K-wires for implant delivery or temporary stabilization of outlying joints (e.g., MTP joint).

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

• 4Webb Medical Inc. Hammertoe Truss System (HTS) (K221283)
• Nvision Vector Hammertoe Correction System (K213421)

Reference Devices

• Nvision Biomedical's Quantum Cervical Plate (K210424)

Submission Summary (Full Text)

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February 16, 2024

Image /page/0/Picture/1 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 & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.

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

Re: K231453

Trade/Device Name: SnapHammer 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, HTY Dated: January 17, 2024 Received: January 17, 2024

Dear Analaura Villarreal-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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,

Eileen
Cadel -S
Digitally signed by
Eileen Cadel -S
Date: 2024.02.16
08:32:09 -05'00'

for

Colin O'Neill, M.B.E. 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)

#### K231453

Device Name SnapHammer Hammertoe Correction System

Indications for Use (Describe)

The SnapHammer Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

# DATE PREPARED

02/15/2024

#### 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/CONSULTANT

Analaura Villarreal-Berain, Extremity Project Engineer Nvision Biomedical Technologies Telephone: [phone] ext. 109 Email: analauravillarreal(@nvisionbiomed.com

#### PROPRIETARY NAME OF SUBJECT DEVICE

SnapHammer Hammertoe Correction System

COMMON NAME Screw, Fixation, Bone

## DEVICE CLASSIFICATION

Smooth or Threaded Metallic Bone Fixation Fastener (Classification Regulations: 21 CFR 888.3040, Product Codes: HWC, HTY, Class: II)

#### PREMARKET REVIEW

Orthopedic Device Panel

#### INDICATIONS FOR USE

The SnapHammer 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. Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

#### DEVICE DESCRIPTION

The SnapHammer Hammertoe Correction System is comprised of an additively manufactured titanium fixation device attached to a snap-off post. The snap-off post aids in a quick insertion and snaps off after implant has been threaded in. The implants are offered in Ø3.0mm and Ø3.50mm diameters and in lengths ranging from 12mm. The system includes drills, implant inserters, and sizers manufactured from medical grade stainless steel.

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## PREDICATE DEVICE IDENTIFICATION

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

| 510(k) Number | Predicate Device Name / Manufacturer | Predicate |
|---------------|--------------------------------------------------|------------|
| K221283 | 4Webb Medical Inc. Hammertoe Truss System (HTS)* | Primary |
| K213421 | Nvision Vector Hammertoe Correction System** | Additional |

*Additional clearances include K190926

** Additional clearances include K183055

The following reference devices are also cited in this submission:

- Nvision Biomedical's Quantum Cervical Plate (K210424)
## SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the SnapHammer Hammertoe Correction System. The following tests were performed to demonstrate safety based on recognized consensus standards and current industry practice:

- . Mechanical Performance: Torsion, driving torque, and axial pullout (per ASTM F543), as well as static and dynamic bending.
- . Additive Manufacturing: Tensile testing per ASTM F3001 and residual powder removal (particle analysis per ASTM F1877).

The results of these tests indicate that the SnapHammer Hammertoe Correction System is substantially equivalent to the predicate devices.

## EQUIVALENCE TO PREDICATE DEVICES

Nvision believes that the SnapHammer Hammertoe Correction System is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design, similar dimensions, and uses similar or identical materials as the devices cleared in K221283, K213421 and K210424. The subject device also has the same intended use, as well as similar technological characteristics (application and technique) as these predicates. The Indications for Use are equivalent and any minor differences in wording choices are insignificant. These technological characteristics have undergone testing and engineering analysis to ensure the device is as safe and effective as the predicates.

## CONCLUSION

Based on the testing performed, including torque, static and dynamic bending 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 SnapHammer Hammertoe Correction System are assessed to be substantially equivalent to the predicate devices.