Additive Orthopaedics Bunion System

K163593 · Additive Orthopaedics, LLC · HRS · Jun 20, 2017 · Orthopedic

Device Facts

• Record ID: K163593
• Device Name: Additive Orthopaedics Bunion System
• Applicant: Additive Orthopaedics, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Jun 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Additive Orthopaedics Bunion System is indication and fusion of fractures, ostotomies and arthrodesis of small bones such as the foot and ankle.

Device Story

Additive Orthopaedics Bunion System consists of titanium alloy (Ti-6AL-4V ELI) plates and locking/non-locking screws; includes surgical site preparation and insertion instruments. Used by orthopedic surgeons in clinical settings for bone fixation following bunion correction osteotomies. Plates are additively manufactured; provided sterile for single-use. Device provides mechanical stabilization of bone segments to facilitate fusion and healing. Clinical benefit derived from maintaining alignment and stability of small bones during the post-operative recovery period.

Clinical Evidence

Bench testing only. Mechanical testing included 4-point bending (static and dynamic) per ASTM F382, and static driving torque, removal torque, and static axial pullout per ASTM F543. Engineering analysis was performed to compare insertion/removal torque, torsional strength, pull-out strength, and bending strength against predicate devices.

Technological Characteristics

Materials: Medical grade titanium alloy (Ti-6AL-4V ELI). Manufacturing: Additive manufacturing. Components: Plates and locking/non-locking screws. Standards: ASTM F382 (bending), ASTM F543 (screws). Sterilization: Provided sterile. Connectivity: None.

Indications for Use

Indicated for alignment, stabilization, and fusion of fractures, osteotomies, and arthrodesis of small bones in the foot and ankle.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Restore Fixation System (K131061)
• Mini MaxLock Extreme Plating System (K120157)
• ExtremiLock System (K131445)
• Ultos Foot Plating system (K141784)

Reference Devices

• Hammertoe Correction System (K153207)
• Bone Wedge System (K160264)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, which is a symbol often associated with healthcare.

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

June 20, 2017

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

Re: K163593

Trade/Device Name: Additive Orthopaedics Locking Lattice Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: May 25, 2017 Received: May 25, 2017

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

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" (21 CFR 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.

# Vincent J. Devlin -S

for

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) K163593

Device Name Additive Orthopaedics Bunion System

#### Indications for Use (Describe)

The Additive Orthopaedics Bunion System is indication and fusion of fractures, ostotomies and arthrodesis of small bones such as the foot and ankle.

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

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K163593

# 510K 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: | February 9, 2017 |

General Device Information:

| Proprietary Name: | Additive Orthopaedics Bunion System |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System Classification: | Common Name: Bunion System |
| | Regulation Name: Single/multiple component metallic<br>bone fixation appliances and accessories;<br>Product Code: HRS- Class II<br>Classification Name and Reference: 21 CFR 888.3030 |
| | Regulation Name: Smooth or Threaded metallic bone fixation fastener and accessories;<br>Product Code: HWC- Class II<br>Classification Name and Reference: 21 CFR 888.3040 |

# Predicate Devices:

| Company | Product Name | 510K Number |
|-----------------------------------------------|-------------------------------------|-------------|
| Primary: Nextremity Solutions, Inc. | Restore Fixation System | K131061 |
| Additional: OrthoHelix Surgical Designs, Inc. | Mini MaxLock Extreme Plating System | K120157 |
| Additional: Osteomed | ExtremiLock System | K131445 |
| Additional: OrthoSolutions, Inc. | Ultos Foot Plating system | K141784 |
| Reference: Additive Orthopaedics, LLC | Hammertoe Correction System | K153207 |
| Reference: Additive Orthopaedics, LLC | Bone Wedge System | K160264 |

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# Description

The Additive Orthopaedics Bunion System consists of a plate and screws (both locking and nonlocking) with surgical site preparation and insertion instruments. The devices is intended to be used for fixation following an osteotomy in bunion correction procedures. The plates are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The screws are manufactured from medical grade titanium alloy. (Ti-6AL-4V). The implants are provided sterile and intended for single use only. The bunion plate comes in 1 individual size and the screws come in 4 lengths.

## Indications for Use

The Additive Orthopaedics Bunion System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.

## (a) (6) Technological Characteristics Comparison

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

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

Mechanical testing including 4 point bending (static and dynamic) per ASTM F382 for the predicate and subject device. Also included were static driving torque and removal torque, and static axial pullout per F543 for the subject device. In addition to the mechanical testing of the screws, an engineering analysis was performed for the subject device to show substantial equivalency with respect to insertion/removal torque, torsional strength, pull-out strength and bending strength. The results of these verification activities demonstrate that the Additive Orthopaedics Bunion System is substantially equivalent to the predicate device identified.

## (b) (3) Substantial Equivalence - Conclusions

The Additive Orthopaedics Bunion System possesses the same technologic characteristics of the predicate devices. These characteristics include the intended use, basic design, material, manufacturing process, size and fundamental technology. The design characteristics of the subject system do not raise any different 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.