(27 days)
Not Found
No
The device description and performance studies focus on mechanical components and material properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is a plating system for fixation of fractures, fusions, osteotomies, and non-unions, which falls under surgical repair rather than a therapeutic treatment that alleviates existing disease or condition.
No
This device is a plating system used for the fixation of fractures, fusions, osteotomies, and non-unions of the radius and ulna. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists physical components such as titanium alloy plates, screws, K-wires, and instrumentation, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures, fusions, osteotomies, and non-unions of the radius and ulna. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates, screws, K-wires, and instrumentation. These are all physical implants and tools used in surgery.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with specimens outside the body.
This device is a surgical implant/instrumentation system used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Skeletal Dynamics Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies and nonunions of the radius and ulna, particularly in osteopenic bone.
Product codes
HRS, HWC
Device Description
The Skeletal Dynamics Distal Elbow Plating System is comprised of:
- Titanium alloy plates and screws in various configurations
- Cobalt chrome polyaxial screws ●
- Stainless steel K-wires (for provisional fixation not for implantation) ●
- System specific instrumentation
The current Skeletal Dynamics Distal Elbow Plating System (K140892) includes the radial head and proximal ulna plates. Plates in double hockey stick, Y and coronoid shape configurations with the same node and inter-node features as the radial head plate are being added for use in the proximal radius and ulna in this submission. All plates are made of medical grade titanium alloy. The radial head, proximal ulna and coronoid plates are offered in left and right applications, the proximal ulna plate is provided in various lengths, and the double hockey stick and Y plates are in single size and have bilateral application. Additional screws length as well as new threaded pegs, washers, polyaxial locking screws, and instruments have been added in the subject system in this submission. The system is provided non-sterile and is sterilized in the user facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radius and ulna
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 preclinical testing demonstrated that the Skeletal Dynamics Distal Elbow Plating System is substantially equivalent to the predicate device currently marketed. Mechanical testing which established equivalency included conformance to ASTM F382-14, Standard Specification and Test Methods for Metallic Bone Plates and ASTM F543-17, Standard Specification and Test Methods for Metallic Bone Screws.
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2017
Skeletal Dynamics, LLC Ms. Ana Escagedo President 8905 SW 87 Avenue, Suite 201 Miami. Florida 33176
Re: K171590
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: May 30, 2017 Received: May 31, 2017
Dear Ms. 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. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/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 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.
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
510(k) Number (if known) K171590
Device Name Distal Elbow Plating System
Indications for Use (Describe)
The Skeletal Dynamics Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies and nonunions of the radius and ulna, particularly in osteopenic bone.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Designation (Part 21 CFR 601 Subpart D) |
|---|
| Same as Currently Listed (21 CFR 201.66) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of Safety and Effectiveness Skeletal Dynamics Distal Elbow Plating System
June 22, 2017
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:
Skeletal Dynamics Distal Elbow Plating System (K140892) DePuy Anatomic Plating System (K082300)
Description of the Device:
The Skeletal Dynamics Distal Elbow Plating System is comprised of:
- Titanium alloy plates and screws in various configurations
- Cobalt chrome polyaxial screws ●
- Stainless steel K-wires (for provisional fixation not for implantation) ●
- System specific instrumentation
The current Skeletal Dynamics Distal Elbow Plating System (K140892) includes the radial head and proximal ulna plates. Plates in double hockey stick, Y and coronoid shape configurations with the same node and inter-node features as the radial head plate are being added for use in the proximal radius and ulna in this submission. All plates are made of medical grade titanium alloy. The radial head, proximal ulna and coronoid plates are offered in left and right applications, the proximal ulna plate is provided in various lengths, and the double hockey stick and Y plates are in single size and have bilateral application. Additional screws length as well as new threaded pegs, washers, polyaxial locking screws, and instruments
4
have been added in the subject system in this submission. The system is provided non-sterile and is sterilized in the user facility.
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:
Engineering analysis and preclinical testing demonstrated that the Skeletal Dynamics Distal Elbow Plating System is substantially equivalent to the predicate device currently marketed. Mechanical testing which established equivalency included conformance to ASTM F382-14, Standard Specification and Test Methods for Metallic Bone Plates and ASTM F543-17, Standard Specification and Test Methods for Metallic Bone Screws.
Conclusion:
The Skeletal Dynamics Distal Elbow Plating System is substantially equivalent to the predicate devices identified in this premarket notification.