(17 days)
No
The description focuses on mechanical components (plates, screws, instrumentation) and mechanical testing, with no mention of software, algorithms, or AI/ML terms.
No.
Plates and screws for treating fractures are considered medical devices, but not therapeutic devices in the sense of delivering therapy. They provide mechanical stabilization rather than a therapeutic action.
No
Explanation: The device is a plating system indicated for "treatment of fractures, fusions, and osteotomies," not for diagnosis.
No
The device description explicitly states it is comprised of plates, screws, and specific instrumentation, which are hardware components.
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 treatment of fractures, fusions, and osteotomies of the radius and ulna. This is a surgical device used directly on the patient's body for structural support and repair.
- Device Description: The device consists of plates, screws, and instrumentation used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device is a surgical implant and associated tools.
N/A
Intended Use / Indications for Use
The FreeFix Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The FreeFix Forearm Plating System is comprised of plates, screws and specific instrumentation. The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radius and ulna
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care facility
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)
Mechanical testing, which established equivalency, includes ASTM F543-23, Standard Specifications and Test Methods for Metallic Bone Screws. All acceptance criteria were met, and the FreeFix Forearm Plating System performed better than its 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.
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/0 description: The image contains the logo of the U.S. Food & 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.
August 1, 2024
Skeletal Dynamics Inc Alexandra Rodriguez Rojas Regulatory Affairs Manager 7300 SW Kendall Dr Miami, Florida 33156
Re: K242055
Trade/Device Name: Freefix Forearm 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 12, 2024 Received: July 15, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements. the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combinationproducts/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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-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/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Christopher Ferreira -S
Christopher Ferreira, MS, RAC 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
Indications for Use
Submission Number (if known)
Device Name
Freefix Forearm Plating System
Indications for Use (Describe)
The FreeFix Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.
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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Image /page/3/Picture/1 description: The image contains the logo for Skeletal Dynamics. The logo consists of a green abstract symbol on the left, followed by the words "skeletal dynamics" in a dark blue font. The word "skeletal" is on the top line, and the word "dynamics" is on the bottom line, with a registered trademark symbol next to it.
510(k) SUMMARY Skeletal Dynamic's FreeFix Forearm Plating System
Submitter:
Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 800 Miami, FL 33156 Phone: 305-596-7585 E-mail: arodriguez@skeletaldynamics.com Contact Person: Alexandra Rodriguez Rojas Date Prepared: July 29th, 2024
Name and Classification
Trade Name: FreeFix Forearm Plating System Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and Accessories Classification Number: 21 CFR §888.3030 Regulatory Class: Class II Product Code: HRS
Predicate Devices
Skeletal Dynamics Forearm Plating System (K200538)
Reference Devices
Distal Elbow Plating System (K231623)
Device Description
The FreeFix Forearm Plating System is comprised of plates, screws and specific instrumentation. The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.
Indications for Use
The FreeFix Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.
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Image /page/4/Picture/1 description: The image contains the logo for Skeletal Dynamics. The logo consists of a green and blue abstract symbol to the left of the company name. The word "skeletal" is in a dark blue, bold font, and the word "dynamics" is in a lighter blue font below it, with a registered trademark symbol to the right.
Substantial Equivalence and Comparison of Technical Characteristics
FreeFix Forearm Plating System is substantially equivalent to the Forearm Plating System (K200538) with respect to the technological characteristics and indications for use. The FreeFix Forearm Plating System has the same general intended use and indications for use, similar technological characteristics, and principles of operation as the previously cleared predicate device mentioned above. Even though there are minor differences in the technological characteristics, these do not address any concerns related to safety or effectiveness of the device.
Comparison of Technological Characteristics with the Predicate Device
The subject FreeFix Forearm Plating System is substantially equivalent to the predicate Forearm Plating System. Both systems are indicated for fractures, fusions, and osteotomies of the radius and ulna. Both systems consist of the same types of components, i.e. plates, screws and specialized instrumentation.
The primary difference is the addition of 2.7mm locking and compression screws and minor modification to the plates to interface with these new screws.
These differences do not raise different questions of safety and effectiveness as demonstrated by the performance testing results and supportive justification.
Performance Testing
Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamics FreeFix Forearm Plating System is equivalent to the predicate device currently marketed. Mechanical testing, which established equivalency, includes ASTM F543-23, Standard Specifications and Test Methods for Metallic Bone Screws. All acceptance criteria were met, and the FreeFix Forearm Plating System performed better than its predicate device.
Conclusions
The Skeletal Dynamic's FreeFix Forearm Plating System is substantially equivalent to the predicate device identified in this premarket notification.