Additive Orthopaedics Hammertoe Correction System

K160264 · Additive Orthopaedics, LLC · HTY · Jun 1, 2016 · Orthopedic

Device Facts

• Record ID: K160264
• Device Name: Additive Orthopaedics Hammertoe Correction System
• Applicant: Additive Orthopaedics, LLC
• Product Code: HTY · Orthopedic
• Decision Date: Jun 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Additive Orthopaedics Hammertoe Correction System is indicated for fixation of fractures, and fusion of small bones in the foot and hand; where such fragments are not under tension or load-bearing.

Device Story

The Additive Orthopaedics Hammertoe Correction System is a monoblock, non-circular shaft implant designed for hammertoe correction. It features barbs along its longitudinal axis to facilitate fixation and is available in both cannulated and non-cannulated versions with 0° and 10° configurations. The device is additively manufactured from medical-grade titanium alloy (Ti-6Al-4V). It is provided in a sterile procedure pack along with a dedicated drill for site preparation. The system is intended for single-use by surgeons in a clinical setting to stabilize small bone fractures or fusions in the hand or foot. By providing mechanical fixation, the implant promotes bone fusion and corrects deformities, benefiting patients by restoring structural integrity to small bones.

Clinical Evidence

Bench testing only. Mechanical testing was performed according to recognized standards, including pull-out force, static flexion-extension resistance, and dynamic flexion-extension resistance.

Technological Characteristics

Monoblock, non-circular shaft implant; cannulated and non-cannulated options; barbs along longitudinal axis; 0° and 10° configurations. Material: Medical grade titanium alloy (Ti-6Al-4V). Manufacturing: Additive manufacturing. Sterilization: Provided sterile. Connectivity: None.

Indications for Use

Indicated for fixation of fractures and fusion of small bones in the foot and hand in patients where fragments are not under tension or load-bearing.

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

• Arthrex Bio-Pin (Marketed as Arthrex Trim-It™ Spin Pin) (K050259)
• Medshape FastForward (Marketed as MedShape Button) (K141420)
• Synchro Medical (Marketed as ToeGrip) (K133477)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 1, 2016

Additive Orthopaedics, LLC Mr. Greg Kowalczyk President 83 Amelia Circle Little Silver, New Jersey 07739

Re: K160264

Trade/Device Name: Additive Orthopaedics Hammertoe Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: April 28, 2016 Received: May 2, 2016

Dear Mr. Kowalczyk:

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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K160264

Device Name

Additive Orthopaedics Hammertoe Correction System

Indications for Use (Describe)

The Additive Orthopaedics Hammertoe Correction System is indicated for fixation of fractures, and fusion of small bones in the foot and hand; where such fragments are not under tension or load-bearing.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary (Per 21 CFR 807.92)

| General Company Information: | Additive Orthopaedics, LLC.<br>Gregory Kowalczyk<br>President<br>83 Amelia Circle<br>Little Silver, NJ 07739<br>Phone: [phone]<br>[e-mail] |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | May 23, 2016 |
| General Device Information | |
| Proprietary Name: | Additive Orthopaedics Hammertoe Correction System |
| Classification: | Common Name: Smooth or threaded metallic bone<br>fixation fastener<br>Product code: HTY- Class II<br>Classification Name and Reference: 21 CFR 888.3040 |
| Predicate Devices | |
| Primary: | |
| • Arthrex, Inc. | Arthrex Bio-Pin<br>(Marketed as Arthrex Trim-It™ Spin Pin)<br>[510(k) K050259] |
| Addional Predicates: | |
| • MedShape, Inc. | Medshape FastForward<br>(Marketed as MedShape Button)<br>[510(k) K141420] |
| • Synchro Medical, Inc. | Synchro Medical<br>(Marketed as ToeGrip)<br>[510(k) K133477] |

#### Description

The Additive Orthopaedics Hammertoe Correction System is a monoblock non-circular shaft implant that is cannulated and non-cannulated and incorporates barbs along its longitudinal axis. The system is provided with a drill designed for preparation of the implant site. The implant device, and the drill, are provided in a sterile procedure pack. The implant is intended for single use only and it is available in 0° and 10° configurations. The implant device is additively manufactured from medical grade titanium alloy (Ti-6A1-4V).

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## Intended Use (Indications)

The Additive Orthopaedics Hammertoe Correction System is indicated for fixation of fractures, and fusion of small bones in the foot and hand; where such fragments are not under tension or load-bearing.

### (a) (6) Technological Characteristics Comparison

The Additive Orthopaedics Hammertoe Correction System and the legally marketed predicated devices have similar indications, dimensions, geometry and materials. The Additive Orthopaedics Hammertoe Correction System is technologically substantially equivalent to the predicate devices.

#### (b) (1) Substantial Equivalence- Non-Clinical Evidence

Mechanical testing was performed as described in relevant recognized standards, including testing for pull-out force, static and dynamic flexion extension resistance.

### (b) (3) Substantial Equivalence

The Additive Orthopaedics Hammertoe Correction System possesses the same technologic characteristics of the predicate devices. These characteristics include the intended use, basic design, material, size and fundamental technology. The design characteristics of the subject system do not raise any new types of questions of safety and effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.