(57 days)
Not Found
No
The description focuses on the mechanical components and intended use of a bone plate system, with no mention of AI or ML capabilities.
Yes.
The device is intended for fracture fixation and wrist arthrodesis, which are therapeutic interventions.
No
Explanation: The device is a bone plate and associated components used for fracture fixation and arthrodesis, which are therapeutic interventions, not diagnostic procedures.
No
The device description explicitly lists hardware components such as a bone plate, screws, k-wires, and instrumentation, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Skeletal Dynamics Dorsal Spanning Plate is a physical implant (a bone plate and screws) used for the fixation of fractures and arthrodesis (fusion) of the wrist. This is a surgical procedure performed inside the body.
The device's purpose is to provide structural support and stability to bones, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Skeletal Dynamics Dorsal Spanning Plate is intended for fixation of fractures involving the distal radius and for wrist arthrodesis.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Skeletal Dynamics Dorsal Spanning Plate consists of a bone plate designed for fracture fixation of the distal radius and wrist arthrodesis. Included in the system are titanium bone screws, k-wires, and specialized instrumentation. The system is provided non-sterile and is sterilized in the user facility.
The Skeletal Dynamics Dorsal Spanning Plate is comprised of:
- · Titanium alloy plate and screws
- · 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, wrist
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)
Preclinical analysis and testing demonstrated that the Skeletal Dynamics Dorsal Spanning Plate is substantially equivalent to the predicate device currently marketed. Mechanical testing which established equivalency included static and dynamic testing. 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
May 12, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Skeletal Dynamics, LLC Ms. Ann Escagedo President 8905 SW 87 Avenue. Suite 201 Miami, Florida 33176
Re: K150675 Trade/Device Name: Dorsal Spanning Plate 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: April 23, 2015 Received: April 24, 2015
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 yours,
Mark N. Melkerson -S
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): K150675
Device Name: Dorsal Spanning Plate
Indications For Use: The Skeletal Dynamics Dorsal Spanning Plate is intended for fixation of fractures involving the distal radius and for wrist arthrodesis.
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)
Page 1 of 1
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510(k) Summary of Safety and Effectiveness Skeletal Dynamics Dorsal Spanning Plate
April 22, 2015
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, President Email: aescagedo@skeletaldynamics.com
Establishment Registration Number: 3006742481
Name and Classification:
Name Dorsal Spanning Plate Common Name Single/multiple component metallic bone fixation appliances and accessories Classification 21 CFR §888.3030 Product Code HRS Class Class II
Predicate Devices:
OptiLock VL Distal Radius Plating System (K093761)
Description of the Device:
The Skeletal Dynamics Dorsal Spanning Plate consists of a bone plate designed for fracture fixation of the distal radius and wrist arthrodesis. Included in the system are titanium bone screws, k-wires, and specialized instrumentation. The system is provided non-sterile and is sterilized in the user facility.
The Skeletal Dynamics Dorsal Spanning Plate is comprised of:
- · Titanium alloy plate and screws
- · Stainless steel K-wires (for provisional fixation not for implantation)
- · System specific instrumentation.
Intended Use:
The Skeletal Dynamics Dorsal Spanning Plate is intended for fixation of fractures involving the distal radius and for wrist arthrodesis.
4
Summary of Technological Characteristics / Substantial Equivalence:
The substantial equivalence of the Skeletal Dynamics Dorsal Spanning Plate 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 Dorsal Spanning Plate is substantially equivalent to the predicate device currently marketed. Mechanical testing which established equivalency included static and dynamic testing. Therefore, the subject device is as safe and effective as legally marketed predicate devices.
Conclusion:
The Skeletal Dynamics Dorsal Spanning Plate is substantially equivalent to the predicate device identified in this premarket notification.