The Skeletal Dynamics Geminus Volar Distal Radius Plate System contains bone plates for the repair of distal volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. Also included are a Hook Plate Extension to buttress a volar marginal fragment, and cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates.

The Geminus Volar Distal Radius Plates are available in various sizes and are made of medical grade titanium alloy. Cortical screws affix the plate to the diaphysis and fixed angle pegs are used for distal bone fragments. The system is provided non-sterile and is sterilized in the user facility.

The Geminus Volar Distal Radius Plate System is comprised of:

Titanium alloy plates, washers and screws
CoCr Cannulated Polyaxial Locking Screw (PLS)
Stainless steel K-wires (for provisional fixation; not for implantation)
System specific instrumentation

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the "Geminus Volar Distal Radius Plate System," through a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive de novo clinical studies to prove safety and efficacy against predefined acceptance criteria.

Therefore, the document does not contain information about:

Acceptance criteria and reported device performance in the context of a clinical study.
Sample size used for a test set, data provenance, or the number/qualifications of experts for ground truth establishment.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI assistance (as this is not an AI/software device).
Standalone (algorithm only) performance.
The type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for a training set or how ground truth for a training set was established.

Instead, the performance testing for this device focused on demonstrating equivalence to the predicate device through engineering analysis and testing.

Key information from the text regarding performance:

Performance Testing: "Engineering analysis and testing demonstrated that the Geminus Volar Distal Radius Plate System is substantially equivalent to predicate devices currently marketed. Therefore, the subject device is as safe and effective as legally marketed predicate devices."
Technological Characteristics: "The substantial equivalence of the Geminus Volar Distal Radius 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."

In summary, the provided text describes a 510(k) clearance based on substantial equivalence, not a study evaluating a device against specific clinical acceptance criteria. The "performance testing" mentioned refers to non-clinical engineering and bench testing to show that the new device performs similarly to predicate devices.

Summary

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Skeletal Dynamics, LLC Ana Escagedo President 7300 North Kendall Drive, Suite 400 Miami, Florida 33156

October 10, 2018

Re: K182492

Trade/Device Name: Geminus Volar Distal Radius 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: September 7, 2018 Received: September 11, 2018

Dear Ana 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. 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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jesse Muir -S 2018.10.10 12:54:36 -04'00'

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) K182492

Device Name

Geminus Volar Distal Radius Plate System

Indications for Use (Describe)

The Skeletal Dynamics Geminus Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius

Type of Use (Select one or both, as applicable)
Research Use (Part 21 CFR 601.21, Subpart B)
Compassionate Use (21 CFR 601.21, Subpart E)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Skeletal Dynamics Geminus Volar Distal Radius Plate System

August 21, 2018

Submitter:

Skeletal Dynamics, LLC 7300 North Kendall Drive Suite 400 Miami, FL 33156 Tel: (305) 596-7585 Fax: (305) 596-7591 Contact: Ana M. Escagedo, President Email: aescagedo@skeletaldynamics.com

Establishment Registration Number: 3006742481

Name and Classification:

Name Geminus Volar Distal Radius Plate System Common Name Plate, Fixation, Bone 21 CFR §888.3030 Classification Product Code HRS Class Class II

Predicate Devices:

Primary: Geminus Volar Distal Radius Plate System (K111620) Synthes LCP Diaphyseal-metaphyseal (dia-meta) Volar Distal Radius Plate (K070946)

Description of the Device:

The Geminus Volar Distal Radius Plate System is comprised of:

Titanium alloy plates, washers and screws ●
CoCr Cannulated Polyaxial Locking Screw (PLS) ●
Stainless steel K-wires (for provisional fixation; not for implantation) ●
System specific instrumentation ●

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Indications for Use:

The Geminus Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius.

Technological Characteristics:

The substantial equivalence of the Geminus Volar Distal Radius 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:

Engineering analysis and testing demonstrated that the Geminus Volar Distal Radius Plate System is substantially equivalent to predicate devices currently marketed. Therefore, the subject device is as safe and effective as legally marketed predicate devices.

Conclusion:

The Skeletal Dynamics Geminus Volar Distal Radius Plate 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.