(29 days)
Not Found
No
The description focuses solely on the mechanical components and materials of a surgical plate system for bone fixation. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for the "fixation of fractures and osteotomies of the distal radius," which directly relates to treating a medical condition rather than diagnosing or providing information.
No
Explanation: The device is a plate system intended for fixation of fractures and osteotomies, which is a therapeutic purpose, not for diagnosing a condition.
No
The device description explicitly lists hardware components such as bone plates, screws, pegs, and instrumentation, indicating it is a physical medical device system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of fractures and osteotomies of the distal radius." This is a surgical procedure performed directly on the patient's body to repair bone.
- Device Description: The device consists of bone plates, screws, pegs, and instrumentation used for surgical implantation and fixation. These are physical implants and tools used in surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens, including blood, tissue, and urine, taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of specimens.
The device described is a surgical implant system used for orthopedic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Skeletal Dynamics Geminus Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius.
Product codes
HRS
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
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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
1
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
2
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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3
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 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 ●
4
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.