FRAGMENT PLATE SYSTEM

K140372 · Skeletal Dynamics, LLC · HRS · Apr 7, 2014 · Orthopedic

Device Facts

• Record ID: K140372
• Device Name: FRAGMENT PLATE SYSTEM
• Applicant: Skeletal Dynamics, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Apr 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Skeletal Dynamics Protean Fragment Plate System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, and pelvis, particularly in osteopenic bone.

Device Story

Protean Fragment Plate System provides surgical stabilization and fixation for small bone fractures and reconstructions. System components include medical-grade titanium alloy plates and screws, cobalt chrome cannulated polyaxial screws, and specialized instrumentation. Stainless steel K-wires are included for provisional fixation only. Device is used by surgeons in clinical settings to stabilize bone fragments; particularly beneficial for osteopenic bone. System is provided non-sterile and requires sterilization by the user facility. Clinical benefit derived from mechanical stabilization of bone fragments to facilitate healing.

Clinical Evidence

Bench testing only. Mechanical testing, including static and dynamic testing, was performed to establish substantial equivalence to the predicate device.

Technological Characteristics

System consists of medical-grade titanium alloy plates and screws, cobalt chrome cannulated polyaxial screws, and stainless steel K-wires. Provided non-sterile. Mechanical fixation via bone plates and screws.

Indications for Use

Indicated for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones (hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis), including osteopenic bone.

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

• DePuy Small Bone Locking Plate System (K081546)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness Skeletal Dynamics Protean Fragment Plate System

March 11, 2014

#### Submitter:

Skeletal Dynamics, LLC 8905 SW 87 Avenue Suite 201 Miami, FL 33176 Tel: [phone] Fax: [phone] Contact: Ana M. Escagedo. Vice President Email: [e-mail]

Establishment Registration Number: 3006742481

#### Name and Classification:

| Name | Protean Fragment Plate System |
|----------------|-------------------------------|
| Common Name | Plate, fixation, bone |
| Classification | 21 CFR §888.3030 |
| Product Code | HRS |
| Class | Class II |

#### Predicate Devices:

DePuy Small Bone Locking Plate System (K081546)

#### Description of the Device:

The Skeletal Dynamics Protean Fragment Plate System is a set of titanium bone plates designed for stabilization and repair of small bone fragments. Included in the set are titanium bone screws, fixation pegs, cobalt chrome cannulated polyaxial screws, and specialized instrumentation.

The Fragment Plates are available in 3 configurations and are made of medical grade titanium alloy. The system is provided non-sterilized in the user facility.

The Skeletal Dynamics Protean Fragment Plate System is comprised of:

- · Titanium alloy plates and screws
- · Cobalt chrome polyaxial screws
- · Stainless steel K-wires (for provisional fixation not for implantation)
- · System specific instrumentation.

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#### Intended Use:

The Skeletal Dynamics Protean Fragment Plate System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, and pelvis, particularly in osteopenic bone.

### Summary of Technological Characteristics / Substantial Equivalence:

The substantial equivalence of the Skeletal Dynamics Protean Fragment Plate 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:

Preclinical analysis and testing demonstrated that the Skeletal Dynamics Protean Fragment Plate System is substantially equivalent to the predicate device currently marketed. Mechanical testing which established equivalency included static and dynamic testing. Therefore, the subject device is as safe and effective as legally marketed predicate devices.

#### Conclusion:

The Skeletal Dynamics Protean Fragment Plate System is substantially equivalent to the predicate device identified in this premarket notification.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 7, 2014

Skeletal Dynamics, LLC Ms. Ana M. Escagedo President 8905 SW 87th Avenue, Suite 201 Miami, Florida 33176

Re: K140372

Trade/Device Name: Protean Fragment Plate 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: February 19, 2014 Received: February 21, 2014

Dear Ms. Escagedo:

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

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#### Page 2 - Ms. Ana M. Escagedo

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Ronald P. Jean -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): K140372

Device Name: Protean Fragment Plate System

Indications For Use: The Skeletal Dynamics Protean Fragment Plate System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, and pelvis, particularly in osteopenic bone.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabet阿莎rank -S

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Division of Orthopedic Devices