(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 described as an "Ulnar Shortening Plating System" indicated for fractures and osteotomies of the ulna, which are interventions aimed at treating or alleviating a medical condition, qualifying it as a therapeutic device.
No
The device is described as a plating system intended for the fixation of fractures and osteotomies, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of physical components made of titanium alloy (plates, screws, pegs) and surgical 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 "fractures and osteotomies, in particular for the ulna." This describes a surgical intervention to treat a physical condition, not a test performed on samples taken from the body to diagnose or monitor a disease.
- Device Description: The device consists of plates, screws, pegs, and surgical instrumentation. These are all physical implants and tools used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the Skeletal Dynamics Ulnar Shortening Plating System is a surgical implant system used to fix bones, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Skeletal Dynamics Ulnar Shortening Plating System is indicated for fractures and osteotomies, in particular for the ulna.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Skeletal Dynamics Ulnar Shortening Plating System consists of Distal Ulnar Shortening Plates with left and right configurations in two lengths and Proximal Ulnar Shortening Plates in two lengths. The Ulnar Shortening Plates are from medical grade Titanium Allov (ASTM F136). Included within the Ulnar Shortening Plating System Set are 3,5mm cortical locking and non-locking bone screws as well as 2.3mm and 2.7mm locking and non-locking pegs from medical grade Titanium Alloy (ASTM F136) for fixation and class 1 surgical instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Performance Testing: Static and dynamic bend strength was submitted with input from ASTM F382, Standard Specification and Test Method for Metallic Bone Plates ASTM F2193, Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System and ASTM F1541. Standard Specification and Test Methods for External Fixation Device. The performance test data as well as engineering analysis provided confirms the Skeletal Dynamics Ulnar Shortening Plating System performance to be substantially equivalent to the 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
October 13, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".
Skeletal Dynamics, Inc. Diana Taylor Sr. Regulatory Affairs Specialist 7300 N. Kendall Drive, Suite 400 Miami, Florida 33156
Re: K201962
Trade/Device Name: Skeletal Dynamics Ulnar Shortening 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: July 10, 2020 Received: July 15, 2020
Dear Diana Taylor:
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-reportingcombination-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, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Device Name
Skeletal Dynamics Ulnar Shortening Plating System Indications for Use (Describe)
The Skeletal Dynamics Ulnar Shortening Plating System is indicated for fractures and osteotomies, in particular for the ulna.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY Ulnar Shortening Plating System
Submitter
Skeletal Dvnamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami. FL 33156 Phone: 305-596-7585 Facsimile: 305-596-7591 Contact Person: Diana Taylor Date: September 10, 2020
Name and Classification:
| Name: | Skeletal Dynamics Ulnar Shortening Plating System |
|---|---|
| Common Name: | Screw, Fixation, Bone |
| Classification: | 21 CFR §888.3030 |
| Regulatory Class: | Class II |
| Product Code(s): | HRS |
Predicate Devices:
Primary Predicate Device: Medartis APTUS 2.5 Ulna Shortening Plate (K141232, 06/23/2014) Additional Predicate Device: Medartis APTUS 2.5 TriLock Plate (K103332, 01/24/2011)
Device Description: The Skeletal Dynamics Ulnar Shortening Plating System consists of Distal Ulnar Shortening Plates with left and right configurations in two lengths and Proximal Ulnar Shortening Plates in two lengths. The Ulnar Shortening Plates are from medical grade Titanium Allov (ASTM F136). Included within the Ulnar Shortening Plating System Set are 3,5mm cortical locking and non-locking bone screws as well as 2.3mm and 2.7mm locking and non-locking pegs from medical grade Titanium Alloy (ASTM F136) for fixation and class 1 surgical instrumentation.
Indications for Use: The Skeletal Dynamics Ulnar Shortening Plating System is indicated for fractures and osteotomies, in particular for the ulna.
Summary of Technological Characteristics: The substantial equivalence of the modifications to the Headless Compression Screw to the cleared predicate system is demonstrated by their identical indications for use, materials, design (fundamental scientific technology) and performance and does not present any new issues of safety or effectiveness.
Performance Testing: Static and dynamic bend strength was submitted with input from ASTM F382, Standard Specification and Test Method for Metallic Bone Plates ASTM F2193, Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System and ASTM F1541. Standard Specification and Test Methods for External Fixation Device. The performance test data as well as engineering analysis provided confirms the Skeletal Dynamics Ulnar Shortening Plating System performance to be substantially equivalent to the predicate devices.
Conclusion: As confirmed within this premarket notification, the Skeletal Dynamics Ulnar Shortening Plating System is equivalent to the legally marketed predicate devices and present no new issues with safety or effectiveness.