(52 days)
No
The device description and intended use focus on mechanical components for bone fixation. There is no mention of AI, ML, image processing, or data-driven analysis.
Yes
The device is intended for stabilization and fixation of bone fragments, which is a therapeutic purpose.
No
The device is a surgical implant system designed for stabilization and fixation of bone fragments, not for diagnosing medical conditions.
No
The device description explicitly states that the system is comprised of physical components such as titanium alloy plates and screws, cobalt chrome polyaxial screws, and stainless steel K-wires, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones...". This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The description details bone plates, screws, pegs, and instrumentation, all of which are components of a surgical implant system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for testing purposes.
Therefore, the Skeletal Dynamics Protean Fragment Plate System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
HRS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, foot, wrist, ankle, humerus, scapula, finger, toe, and pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
DePuy Small Bone Locking Plate System (K081546)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
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K140372 page 1 of 2
Image /page/0/Picture/2 description: The image shows the logo for Skeletal Dynamics. The logo consists of a stylized black symbol to the left of the words "skeletal dynamics" in black font. The symbol appears to be four squares arranged to form a larger square.
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: (305) 596-7585 Fax: (305) 596-7591 Contact: Ana M. Escagedo. Vice President Email: aescagedo@skeletaldynamics.com
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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K140372 page 2 of 2
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.
2
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
3
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
4
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
Page 1 of 1
Division of Orthopedic Devices