(90 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is a plating system used for the treatment of fractures and non-unions of the distal humerus, which constitutes a therapeutic intervention.
No
Explanation: The device is a plating system intended for the internal fixation of humerus fractures, not for diagnosis.
No
The device description explicitly states it consists of titanium bone plates, screws, fasteners, and instrumentation, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating bone fractures and related conditions of the distal humerus through surgical implantation of plates and screws. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device consists of implants (plates, screws) and surgical instruments. These are used to physically stabilize and repair bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for surgical use in vivo.
N/A
Intended Use / Indications for Use
The Skeletal Dynamics 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Skeletal Dynamics 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 alloy. Locking and compression screws in 2.7mm, 3.5mm and 4.5mm and 3.0mm polyaxial locking screws are provided in various lengths. Also included in the system is specialized instrumentation. The System is provided non-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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamics Distal Humerus Plating System is equivalent to predicate devices currently marketed. Mechanical testing which established equivalency included ASTM F382, Standard Specification and Test Methods for Metallic Bone Plates, and ASTM F543, Standard Specification and Test Methods for Metallic Bone Screws. Therefore, the subject device is as safe and effective as the legally marketed predicate device.
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
May 14, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".
Skeletal Dynamics, Inc. Ana M. Escagedo President 7300 N. Kendall Drive, Suite 400 Miami, Florida 33156
Re: K200367
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, HWC Dated: February 13, 2020 Received: February 14, 2020
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
1
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-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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, MPH 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
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510(k) Number (if known)
Device Name
Distal Humerus Plating System
Indications for Use (Describe)
The Skeletal Dynamics 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.
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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510(k) SUMMARY Skeletal Dvnamics Inc.'s Distal Humerus Plating System
Submitter
Skeletal Dynamics, Inc. 7300 N. Kendall Drive Suite 400 Miami, FL 33156 Phone: 305-596-7585 Facsimile: 305-596-7591 Contact Person: Ana M. Escagedo Date Prepared: March 29, 2020
Name and Classification
| Name: | Distal Humerus Plating System |
|---|---|
| Common Name: | Plate, Fixation, Bone |
| Classification: | 21 CFR §888.3030 |
| Regulatory Class: | Class II |
| Product Code: | HRS |
Predicate Device
Synthes Variable Angle LCP Elbow System (Medial and Posterolateral Distal Humerus Plates), K120717
Additional Predicate: Synthes 3.5mm LCP Distal Humerus System, K033995
Device Description
The Skeletal Dynamics 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 alloy. Locking and compression screws in 2.7mm, 3.5mm and 4.5mm and 3.0mm polyaxial locking screws are provided in various lengths. Also included in the system is specialized instrumentation. The System is provided non-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 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.
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.
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Performance Testing
Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamics Distal Humerus Plating System is equivalent to predicate devices currently marketed. Mechanical testing which established equivalency included ASTM F382, Standard Specification and Test Methods for Metallic Bone Plates, and ASTM F543, Standard Specification and Test Methods for Metallic Bone Screws. Therefore, the subject device is as safe and effective as the legally marketed predicate device.
Conclusions
The Skeletal Dynamics Distal Humerus Plating System is substantially equivalent to the predicate device identified in this premarket notification.