The Skeletal Dynamics Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna, particularly in osteopenic bone.

Device Description

The Skeletal Dynamics Distal Elbow System consists of various bone plates designed for fracture fixation, fusions, osteotomies and non-unions of the radius and ulna. Included in the system are titanium bone screws and pegs, cobalt chrome cannulated polyaxial screws, k-wires, and specialized instrumentation.

The Radial Head and the Proximal Ulna plates are made of medical grade titanium alloy. They are offered in left and right applications. The Proximal Ulna plate is provided in various lengths. The system is provided non-sterile and is sterilized in the user facility.

The Skeletal Dynamics 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.

AI/ML Overview

This document is a 510(k) premarket notification for the "Skeletal Dynamics Distal Elbow Plating System." It describes the device, its intended use, and claims substantial equivalence to a predicate device based on performance testing. However, it does not contain the level of detail requested for acceptance criteria and a study proving those criteria are met for an AI-powered diagnostic device.

Here's why and what information is missing:

This document describes a medical device (bone plating system), not an AI diagnostic device. The questions regarding ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and data provenance are highly specific to AI/ML diagnostic tools. These concepts are not applicable to the mechanical bone plating system described here.
The "Performance Testing" section states mechanical testing was performed, including static and dynamic testing on plates, and pullout strength and torque testing on screws. This is typical for orthopedic implants to demonstrate structural integrity and mechanical equivalence.
The "Acceptance Criteria" for this type of device would generally involve meeting certain mechanical performance thresholds (e.g., strength, fatigue life, screw retention) set by recognized standards (like ASTM or ISO) relevant to orthopedic implants. These specific criteria and the detailed results showing compliance are summarized but not explicitly listed in this FDA letter, which instead focuses on the determination of substantial equivalence.

Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text because it pertains to a different type of medical device (a mechanical implant) than what your questions are designed for (an AI diagnostic tool).

If this document were about an AI diagnostic device, the necessary information would typically include sections detailing clinical study design, endpoints, statistical analysis, and comparisons to human performance or ground truth.

Summary

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August 28, 2014

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

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

Re: K140892

Trade/Device Name: Distal Elbow 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, HWC Dated: July 31, 2014 Received: August 4, 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

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Page 2 - Ms. Ana M. Escagedo

device-related 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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

K140892 510(k) Number (if known):

Device Name: Distal Elbow Plating System

Indications For Use: The Skeletal Dynamics Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna, 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)

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510(k) Summary of Safety and Effectiveness Skeletal Dynamics Distal Elbow Plating System

August 25, 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	Distal Elbow Plating System
Common Name	Plate, fixation, bone
Classification	21 CFR §888.3030
Product Code	HRS, HWC
Class	Class II

Predicate Devices:

DePuy Anatomic Locking Plating System (K082300)

Description of the Device:

The Skeletal Dynamics 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 Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna, particularly in osteopenic bone.

Summary of Technological Characteristics / Substantial Equivalence:

The substantial equivalence of the Skeletal Dynamics Distal Elbow 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:

Preclinical analysis and testing demonstrated that the Skeletal Dynamics Distal Elbow Plating System is substantially equivalent to the predicate device currently marketed. Mechanical testing performed to establish equivalency included static and dynamic testing on the plates and pullout strength and torque testing on the screws. Therefore, the subject device is as safe and effective as legally marketed predicate devices.

Conclusion:

The Skeletal Dynamics Distal Elbow Plating System is substantially equivalent to the predicate device identified in this premarket notification.

Regulation Number and Section

§ 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.