Skeletal Dynamics Forearm Plating System

K200538 · Skeletal Dynamics, Inc. · HRS · Jun 1, 2020 · Orthopedic

Device Facts

• Record ID: K200538
• Device Name: Skeletal Dynamics Forearm Plating System
• Applicant: Skeletal Dynamics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jun 1, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Skeletal Dynamics Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.

Device Story

The Skeletal Dynamics Forearm Plating System consists of midshaft radius and ulna plates used for bone fixation. The system is intended for surgical use by orthopedic surgeons to stabilize bone segments during healing of fractures, fusions, or osteotomies. The plates are implanted to provide structural support and maintain alignment of the radius and ulna. The device is a passive orthopedic implant; it does not involve electronic inputs, algorithms, or software. Clinical benefit is derived from the mechanical stabilization of bone, facilitating proper union and recovery.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ASTM F382, Standard Specification and Test Methods for Metallic Bone Plates, demonstrated performance equivalent to the predicate devices.

Technological Characteristics

Metallic bone plates manufactured from titanium alloy (ASTM F-136). Available in multiple lengths and hole configurations. Passive implantable device. No energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring treatment of fractures, fusions, and osteotomies of the radius and ulna.

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

• Acumed, LLC, Congruent Bone Plate System (K102998)
• Skeletal Dynamics, GEMINUS Plate System (K122737)

Submission Summary (Full Text)

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June 1, 2020

Skeletal Dynamics, Inc. Diana Taylor Sr. Regulatory Affairs Specialist 7300 N. Kendall Drive, Suite 400 Miami, Florida 33156

Re: K200538

Trade/Device Name: Skeletal Dynamics Forearm Plating 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: March 2, 2020 Received: March 3, 2020

Dear Diana Taylor:

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.

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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 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, MPH 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) K200538

#### Device Name

Skeletal Dynamics Forearm Plating System

Indications for Use (Describe)

The Skeletal Dynamics Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.

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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Image /page/3/Picture/1 description: The image shows the logo for Skeletal Dynamics. On the left side of the logo is a green and blue abstract symbol that looks like four leaves arranged in a square. To the right of the symbol is the word "skeletal" in blue, with a registered trademark symbol next to it. Below the word "skeletal" is the word "dynamics" in blue.

K200538

7300 North Kendall Drive | Suite 400 | Miami, Florida 33156

phone: [phone]

fax: [phone]

# 510(k) SUMMARY Skeletal Dynamics Inc.'s Forearm Plating System

# Submitter

Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156 Phone: [phone] Facsimile: 305-596-7591 Contact Person: Diana Taylor Date: June 1, 2020

# Name and Classification

Name: Forearm Plating System Plate, Fixation, Bone Common Name: 21 CFR §888.3030 Requlatory Classification: Class: Class II Product Code: HRS

# Predicate Devices

Primary Predicate: Acumed, LLC, Congruent Bone Plate System, K102998, 01/04/2011 Additional Predicate: Skeletal Dynamics, GEMINUS Plate System K122737, 10/03/2012

# Device Description

The Skeletal Dynamics Forearm Plating System include Midshaft Radius Plates and Midshaft Ulna Plates, manufactured from titanium alloy (ASTM F-136) and available in multiple lengths and hole configurations.

# Indications for Use

The Skeletal Dynamics Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.

# Summary of Technological Characteristics

The substantial equivalence of the Skeletal Dynamics Forearm Plating System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging and does not present any new issues of safety or effectiveness.

#### Performance Testing

Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamics Forearm Plating System is equivalent to the predicate device currently marketed. Mechanical testing, which established equivalency, includes ASTM F382, Standard Specification and Test Methods for Metallic Bone Plates, Therefore, the subject device is as safe and effective as the legally marketed predicate device.

#### Conclusions

The Skeletal Dynamics Forearm Plating System is substantially equivalent to the predicate devices identified in this premarket notification.