The Skeletal Dynamics Midshaft Humerus Plating System is indicated for fixation of the humerus for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients.

Device Description

The Skeletal Dynamics Midshaft Humerus Plating System include Broad and Narrow Midshaft Humerus Plates and 4.5 mm Locking and Compression Screws made from medical grade titanium alloy. The bottom surface of the plates feature undercuts to facilitate bending, when necessary, to ensure the best fit for differing patient anatomy and oblong threaded slots for the screws. The locking screws feature a double lead locking thread on the head to mate with the plate's threaded slots.

AI/ML Overview

This FDA 510(k) summary describes a medical device, the Skeletal Dynamics Midshaft Humerus Plating System, not an AI/ML powered device. Therefore, the information typically required for describing the acceptance criteria and study proving an AI/ML device meets them (such as details on sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training and test sets) is not applicable and not present in this document.

The provided document instead focuses on demonstrating substantial equivalence to a predicate device through:

1. Acceptance Criteria and Device Performance (based on mechanical testing):

Acceptance Criteria (Benchtop Equivalence)	Reported Device Performance
Performance to be substantially equivalent to the Synthes 4.5 mm Locking Compression Plate (LCP) System, as demonstrated by recognized standards.	Mechanical testing performed according to: - ASTM F382: Standard Specification and Test Methods for Metallic Bone Plates. - ASTM F543: Standard Specification and Test Methods for Metallic Bone Screws. Engineering analysis was used to establish substantial equivalence of the subject screw to the secondary predicate with respect to pullout testing.

2. Details not applicable for AI/ML devices:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "test set" here refers to physical components subjected to mechanical testing, not a dataset of patient images or clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for mechanical devices is established through engineering specifications and standardized test methods, not expert human assessment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical implant, not an AI diagnostic or assistance tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the mechanical device, the "ground truth" is defined by the performance parameters outlined in the ASTM standards (e.g., strength, stiffness, fatigue life) that the device must meet or demonstrate equivalence to the predicate.
The sample size for the training set: Not applicable. There is no "training set" for this type of device.
How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study conducted was a benchtop mechanical testing study designed to demonstrate the substantial equivalence of the Skeletal Dynamics Midshaft Humerus Plating System to its predicate device, the Synthes 4.5 mm Locking Compression Plate (LCP) System.

Methods: The testing followed established ASTM standards: ASTM F382 for bone plates and ASTM F543 for bone screws. Additionally, engineering analysis was used for screw pullout testing equivalence to a secondary predicate (ARMAR™ / ARTIS™ Screws).
Conclusion: The performance testing, comprising both mechanical testing and engineering analysis, demonstrated that the Skeletal Dynamics Midshaft Humerus Plating System is substantially equivalent to the predicate device in terms of safety and effectiveness. The minor differences in design did not negatively impact safety, effectiveness, or performance.

Summary

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May 14, 2020

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

Re: K200701

Trade/Device Name: Skeletal Dynamics Midshaft Humerus 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: March 16, 2020 Received: March 18, 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 (QS) 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200701

Device Name

Skeletal Dynamics Midshaft Humerus Plating System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMAR Skeletal Dynamics Inc. Midshaft Plating System

Submitter

Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156 Phone: 305-596-7585 Facsimile: 305-596-7591 Contact Person: Diana Taylor Date: May 13, 2020

Name and Classification

Name:	Midshaft Humerus Plating System
Common Name:	Plate, Fixation, Bone
Classification:	21 CFR §888.3030
Regulatory Class:	Class II
Product Code(s):	HRS, HWC

Predicate Devices

Primary Predicate: K082807, 01/13/2009, Synthes 4.5 mm Locking Compression Plate (LCP) System Secondary Predicate: K171320, 03/08/2018, ARMAR™ / ARTIS™ Screws Reference Devices: K171590, 06/27/2017, Geminus Volar Distal Radius System K182492, 10/10/2018, Distal Elbow Plating System

Device Description

Indications for Use

Summary of Technological Characteristics

The substantial equivalence of the Skeletal Dynamics Midshaft Humerus 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 Midshaft Humerus Plating System performance to be substantially equivalent to the Synthes 4.5 mm Locking Compression Plate (LCP) System. Mechanical testing which established equivalency included ASTM F382, Standard Specification and Test Methods for Metallic Bone Plates and ASTM F543, Standard Specification and Test Methods for Metallic Bone Screws. Engineering analysis was used to establish substantial equivalence of the subject screw to the secondary predicate with respect to pullout testing.

Conclusions

As shown within this premarket notification, the Skeletal Dynamics Midshaft Humerus Plating System is equivalent to the legally marketed predicate device and confirmed that the minor differences between the two systems will not impact safety, effectiveness or performance of the Midshaft Humerus Plating System.

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.