Additive Orthopaedics Bone Wedge System

K153207 · Additive Orthopaedics, LLC · HRS · Sep 7, 2016 · Orthopedic

Device Facts

• Record ID: K153207
• Device Name: Additive Orthopaedics Bone Wedge System
• Applicant: Additive Orthopaedics, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Sep 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Additive Orthopaedics Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: *Cotton (opening wedge) osteotomies of the medial cuneiform *Evans lengthening osteotomies The Additive Orthopaedics Bone Wedges are intended for use with ancillary plating fixation. The Additive Orthopaedics Bone Wedges are not intended for use in the spine.

Device Story

Additive Orthopaedics Bone Wedge System consists of wedge-shaped implants used for internal bone fixation during foot and ankle osteotomies or fracture repair. Implants are additively manufactured from medical-grade titanium alloy (Ti-6AL-4V ELI) and provided sterile for single-use. Available in 18 sizes/configurations to address skeletal deformities. Used by orthopedic surgeons in clinical settings; requires ancillary plating fixation for stability. Device provides structural support to bone segments during healing. Benefit includes correction of skeletal deformities through precise wedge placement.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including morphological characterization, mechanical testing (friction, roughness, durability/abrasion, and compressive fatigue), and biocompatibility testing.

Technological Characteristics

Material: Medical grade titanium alloy (Ti-6AL-4V ELI). Manufacturing: Additive manufacturing. Form factor: Wedge-shaped implants in 18 sizes/configurations. Sterilization: Provided sterile. Intended for single use. Requires ancillary plating fixation.

Indications for Use

Indicated for internal bone fixation for fractures or osteotomies in the ankle and foot, specifically Cotton (opening wedge) osteotomies of the medial cuneiform and Evans lengthening osteotomies. Not for use in the spine. Requires ancillary plating fixation.

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

• Integra Titanium Bone Wedges (K131360)
• Web Osteotomy Bone Wedge (K130185)

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 stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

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

September 7, 2016

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

Re: K153207

Trade/Device Name: Additive Orthopaedics Bone Wedge System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 29, 2016 Received: August 5, 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 (OS) 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/Resourcesfor You/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,

# 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) K153207 (page 1 of 1)

Device Name Additive Orthopaedics Bone Wedge System

Indications for Use (Describe)

The Additive Orthopaedics Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:

*Cotton (opening wedge) osteotomies of the medial cuneiform *Evans lengthening osteotomies

The Additive Orthopaedics Bone Wedges are intended for use with ancillary plating fixation.

The Additive Orthopaedics Bone Wedges are not intended for use in the spine.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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><a href="mailto:[e-mail]">[e-mail]</a> |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | September 7, 2016 |

General Device Information:

| Proprietary Name: | Additive Orthopaedics Bone Wedge System |
|-------------------|-----------------------------------------|
|-------------------|-----------------------------------------|

| System Classification: | Common Name: Bone Wedge System<br>Regulation Name: Single/multiple component metallic bone fixation appliances and accessories;<br>Product Code: HRS- Class II<br>Classification Name and Reference: 21 CFR 888.3030 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Predicate Devices:

| Company | Product Name | 510K Number |
|---------------------------------------------------|----------------------------------------------------------|--------------------|
| Primary: Integra, Inc.<br>Additional: 4-Web, Inc. | Integra Titanium Bone Wedges<br>Web Osteotomy Bone Wedge | K131360<br>K130185 |

#### Description

The Additive Orthopaedics Bone Wedge System is a series of wedge-shaped devices intended to be used for internal bone fixation for bone fractures or osteotomies in the foot and ankle. The wedges are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The implants are provided sterile and intended for single use only. The wedges come in 18 individual sizes and configurations to correct various skeletal deformities in the foot. The Additive Orthopaedics Bone Wedge System is intended to be used with ancillary plating fixation.

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### Intended Use (Indications)

The Additive Orthopaedics Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:

*Cotton (opening wedge) osteotomies of the medial cuneiform

*Evans lengthening osteotomies

The Additive Orthopaedics Bone Wedges are intended for use with ancillary plating fixation.

The Additive Orthopaedics Bone Wedges are not intended for use in the spine.

## (a) (6) Technological Characteristics Comparison

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

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

Morphological characterization, mechanical testing (including, friction, roughness, durability/abrasion, and compressive fatigue) as well as biocompatibility testing were performed on the proposed device. The results of these verification activities demonstrate that the Additive Orthopaedics Bone Wedges are substantially equivalent to the predicate device identified.

## (b) (3) Substantial Equivalence

The Additive Orthopaedics Bone Wedge 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.