(30 days)
Not Found
No
The 510(k) summary describes a mechanical bone plating system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a Distal Humerus Plating System, which is used for the fixation of bone fractures and osteotomies. It is an orthopedic implant, not a device that claims to directly treat or cure a disease or condition through therapeutic action.
No
The device is a plating system used for the surgical fixation of distal humerus fractures, osteotomies, and non-unions. It consists of plates, screws, and instruments, which are used to mechanically stabilize bone, not to diagnose a condition.
No
The device description explicitly states it consists of physical components such as titanium bone plates, screws, and instrumentation, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical treatment of fractures, osteotomies, and non-unions of the distal humerus. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device consists of implants (plates and screws) and surgical instruments. These are used in the body during surgery, not on samples from the body for diagnostic purposes.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens such as blood, urine, or tissue outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a surgical implant system.
N/A
Intended Use / Indications for Use
The Skeletal Dynamics Inc's Distal Humerus Plating System is intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
Product codes
HRS
Device Description
The Skeletal Dynamics Inc's Distal Humerus Plating System consists of five titanium bone plates in different shapes (medial direct, lateral direct, lateral capitellar, and supracondylar), in multiple lengths, and in left and right configurations to address distal humerus fractures. The plates are made of medical grade titanium allov. The system also includes 2.7mm, 3.5mm and 4.5mm locking and compression titanium alloy screws and 3.0mm polyaxial Cobalt Chrome locking screws which are provided in various lengths. The System is being modified to include additional lengths of existing screw options and new 3.5mm and 4.5mm locking and compression Titanium Alloy Screws. Additionally, minor modifications have been made to the plates to accept the new screws above mentioned. Also included in the system is specialized instrumentation. The System is provided nonsterile for sterilization in the user facility.
The Distal Humerus Plating System is comprised of:
- · Titanium alloy plates, screws, and fasteners
- · CoCr Cannulated Polyaxial Locking Screws (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 humerus
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
Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamics Inc's Distal Humerus Plating System is equivalent to predicate devices currently marketed. Static testing, which established equivalency included ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws. The subject device is as safe and effective as the legally marketed predicate device.
Key Metrics
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
January 13, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Skeletal Dynamics, Inc. Alexandra Rodriguez Regulatory Affairs Specialist 7300 N. Kendall Drive, Suite 400 Miami, Florida 33156
Re: K213895
Trade/Device Name: Distal 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 Dated: December 7, 2021 Received: December 14, 2021
Dear Alexandra Rodriguez:
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
1
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-reporting-
combination-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 medical devices and radiation-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 Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
Device Name
Distal Humerus Plating System
Indications for Use (Describe)
The Skeletal Dynamics Inc's Distal Humerus Plating System is intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
Type of Use (Select one or both, as applicable)
2 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 Inc.'s Distal Humerus Plating System
Submitter
Skeletal Dynamics, Inc. 7300 N. Kendall Drive Suite 400 Miami, FL 33156 Phone: 305-596-7585 ext.7121 Facsimile: 305-596-7591 Contact Person: Alexandra Rodriquez Date Prepared: January 13, 2022
Name and Classification
Trade Name: Distal Humerus Plating System Classification Name: Single/multiple component metallic bone fixation appliances and accessories Classification Number: 21 CFR §888.3030 Requlatory Class: Class II Product Code: HRS
Predicate Devices
Distal Humerus Plating System, K200367
Device Description
The Skeletal Dynamics Inc's Distal Humerus Plating System consists of five titanium bone plates in different shapes (medial direct, lateral direct, lateral capitellar, and supracondylar), in multiple lengths, and in left and right configurations to address distal humerus fractures. The plates are made of medical grade titanium allov. The system also includes 2.7mm, 3.5mm and 4.5mm locking and compression titanium alloy screws and 3.0mm polyaxial Cobalt Chrome locking screws which are provided in various lengths. The System is being modified to include additional lengths of existing screw options and new 3.5mm and 4.5mm locking and compression Titanium Alloy Screws. Additionally, minor modifications have been made to the plates to accept the new screws above mentioned. Also included in the system is specialized instrumentation. The System is provided nonsterile for sterilization in the user facility.
The Distal Humerus Plating System is comprised of:
- · Titanium alloy plates, screws, and fasteners
- · CoCr Cannulated Polyaxial Locking Screws (PLS)
- · Stainless steel K-wires (for provisional fixation; not for implantation)
- · System specific instrumentation
Indications for Use
The Skeletal Dynamics Inc's Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
4
Summary of Technological Characteristics
The substantial equivalence of the Distal 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 Inc's Distal Humerus Plating System is equivalent to predicate devices currently marketed. Static testing, which established equivalency included ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws. The subject device is as safe and effective as the legally marketed predicate device.
Conclusions
The Skeletal Dynamics Inc's Distal Humerus Plating System is substantially equivalent to the predicate device identified in this premarket notification.