(87 days)
The Skeletal Dynamics Distal Elbow Plating System is indicated for fixation of fractures, osteotomies and nonunions of the radius and ulna, particularly in osteopenic bone.
The predicate Skeletal Dynamics Distal Elbow Plating System (K171590) consists of medical grade titanium alloy radial head plates, proximal ulna plates, double hockey stick, Y and coronoid plates designed for fracture fixation, fusions, osteotomies and non-unions of the proximal radius and ulna. Included in the system are titanium bone screws and pegs, cobalt chrome cannulated polyaxial screws, k-wires, and specialized instrumentation.
The system is provided non-sterile and is sterilized in the user facility.
The modifications to the currently marketed Distal Elbow Plating System include the following.
- . Two new Proximal Ulna Plate extension options
- New 3.5mm FreeFix™ screw options .
- Addition of Protean Radial Head Plate configurations. .
- Addition of Modified Proximal Ulna Plate configurations. .
The provided text is a 510(k) premarket notification for a medical device called the "Distal Elbow Plating Sytem." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and performance testing for mechanical properties.
Crucially, this document does NOT describe an AI/ML-driven device or study involving acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, specificity, or human-in-the-loop studies.
Therefore, I cannot extract the information required by your prompt, such as:
- A table of acceptance criteria and reported device performance (in the context of AI/ML diagnostic performance)
- Sample size for test set and data provenance
- Number of experts used to establish ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Sample size for training set
- How ground truth for training set was established
The "Performance Testing" section in the document refers to mechanical testing (e.g., ASTM standards for metallic bone plates and screws) to ensure the physical integrity and strength of the implant device, not its performance as a diagnostic or AI-assisted tool.
In summary, this document is entirely unrelated to the type of AI/ML device performance study details requested in your prompt.
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August 28, 2023
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Skeletal Dynamics Inc Alexandra Rodriguez Rojas Regulatory Affairs Manager 7300 North Kendall Drive Miami, Florida 33156
Re: K231623
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: June 2, 2023 Received: June 2, 2023
Dear Alexandra Rodriguez Rojas:
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
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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 -S
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
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Indications for Use
510(k) Number (if known) K231623
Device Name
Distal Elbow Plating System
Indications for Use (Describe)
The Skeletal Dynamics Distal Elbow Plating System is indicated for fixation of fractures, osteotomies and nonunions of the radius and ulna, particularly in osteopenic bone.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Submitter
Skeletal Dynamics, Inc. 7300 N. Kendall Drive Suite 400 Miami, FL 33156 Phone: 305-596-7585 Facsimile: 305-596-7591 Contact Person: Alexandra Rodriquez Rojas Date Prepared: August 11, 2023
Name and Classification
| Trade Name: | Distal Elbow Plating System |
|---|---|
| Common Name: | Plate, fixation, bone (Primary) |
| Screw, Fixation, Bone | |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances andAccessories (Primary)Smooth or threaded metallic bone fixation fastener |
| Classification Number: | 21 CFR §888.3030 (Primary)21 CFR §888.3040 |
| Device Class: | Class II |
| Product Code: | HRS (Primary)HWC |
Primary Predicate Device
K171590 -Distal Elbow Plating System (Skeletal Dynamics) Additional Predicate Devices K140892 - Distal Elbow Plating System (Skeletal Dynamics) K082300 - Anatomic Locking Plating System (Depuy Orthopaedics)
Device Description
The predicate Skeletal Dynamics Distal Elbow Plating System (K171590) consists of medical grade titanium alloy radial head plates, proximal ulna plates, double hockey stick, Y and coronoid plates designed for fracture fixation, fusions, osteotomies and non-unions of the proximal radius and ulna. Included in the system are titanium bone screws and pegs, cobalt chrome cannulated polyaxial screws, k-wires, and specialized instrumentation.
The system is provided non-sterile and is sterilized in the user facility.
The modifications to the currently marketed Distal Elbow Plating System include the following.
- . Two new Proximal Ulna Plate extension options
- New 3.5mm FreeFix™ screw options .
- Addition of Protean Radial Head Plate configurations. .
- Addition of Modified Proximal Ulna Plate configurations. .
Indications for Use
The Skeletal Dynamics Distal Elbow Plating System is indicated for fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna, particularly in osteopenic bone.
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Summary of Technological Characteristics
The substantial equivalence of the Distal Elbow Plating System to the predicate and reference devices 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
Enqineering analysis and mechanical testing demonstrated that the Skeletal Dynamics Distal Elbow Plating System is equivalent to predicate devices currently marketed. Static and Dynamic testing which established equivalency included conformance to ASTM F382-17, Standard Specification and Test Method for Metallic Bone Plates, ASTM F543-17, Standard Specification and Test Methods for Metallic Medical Bone Screws and ASTM F1839-08(2021), Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments. Therefore, the subject device is as safe and effective as the legally marketed predicate device.
Conclusions
The Skeletal Dynamics Distal Elbow Plating System is substantially equivalent to the predicate Distal Elbow Plating System identified in this premarket notification.
§ 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.