(28 days)
Not Found
No
The description focuses on the mechanical properties and dimensions of the threaded nails, with no mention of AI or ML capabilities.
Yes
The device is indicated for "fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies," which are therapeutic medical interventions.
No
Explanation: The device is described as a system for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies. This is a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it consists of physical components (threaded nails made of titanium alloy) and does not mention any software as a component of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Hand Trauma Threaded Nail System is a surgical implant used for the fixation of bones and joints. It is a physical device inserted into the body.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples or provide diagnostic information. Its function is purely mechanical and structural.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Hand Trauma Threaded Nail System is indicated for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized threaded nail.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Skeletal Dynamic's Hand Trauma Threaded Nail System consists of cannulated and noncannulated threaded nails, with distal and proximal threads with a pitch differential between the threads which creates compression during threaded nail insertion. The threaded nails are selftapping, available in multiple diameters and various lengths and made of titanium alloy.
- 2.0mm non-cannulated Hand Trauma Threaded nail:12mm-28mm in 2mm increments
- 2.0mm non-cannulated Hand Trauma Threaded Nails: 28mm 48mm in 4mm increments.
- · 3.0mm cannulated Hand Trauma Threaded Nails: 20mm 70mm in 5mm increments.
- · 3.5mm cannulated Hand Trauma Threaded Nails: 25mm 70mm in 5mm increments.
- · 4.0mm cannulated Hand Trauma Threaded Nails: 25mm 70mm in 5mm increments.
The system is provided non-sterile and is sterilized in the user facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The addition of the smaller sizes for the 2.0mm Non-Cannulated Threaded Nails and the 3.0mm Cannulated threaded Nails was verified through an Axial Pullout Strength as it is the only testing affected by this change. The subject testing followed the FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway." The results demonstrated that the Skeletal Dynamics new Hand Trauma Threaded Nail Sizes are as safe and effective as the 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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
April 28, 2023
Image /page/0/Picture/1 description: The image contains 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 Rojas Regulatory Affairs Manager 7300 North Kendall Drive Suite 400 Miami, Florida 33156
Re: K230908
Trade/Device Name: Hand Trauma Threaded Nail System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 30, 2023 Received: March 31, 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
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 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,
Image /page/1/Picture/5 description: The image contains the name "Shumaya Ali-S" in a large, sans-serif font. The text is black and stands out against a white background. The name is written on a single line, with a hyphen connecting "Ali" and "S". The text is centered in the image.
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Hand Trauma Threaded Nail System
Indications for Use (Describe)
The Hand Trauma Threaded Nail System is indicated for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized threaded nail.
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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3
Special 510(k) SUMMARY Skeletal Dynamic's Hand Trauma Threaded Nail System
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 Roias Date Prepared: March 30, 2023
Name and Classification
Trade Name: Hand Trauma Threaded Nail System Classification Name: Smooth or Threaded Metallic Bone Fixation Fastener Classification Number: 21 CFR §888.3040 Requlatory Class: Class II Product Code: HWC
Predicate Devices
Hand Trauma Screw System, K220723
Device Description
The Skeletal Dynamic's Hand Trauma Threaded Nail System consists of cannulated and noncannulated threaded nails, with distal and proximal threads with a pitch differential between the threads which creates compression during threaded nail insertion. The threaded nails are selftapping, available in multiple diameters and various lengths and made of titanium alloy.
- 2.0mm non-cannulated Hand Trauma Threaded nail:12mm-28mm in 2mm increments
- 2.0mm non-cannulated Hand Trauma Threaded Nails: 28mm 48mm in 4mm increments.
- · 3.0mm cannulated Hand Trauma Threaded Nails: 20mm 70mm in 5mm increments.
- · 3.5mm cannulated Hand Trauma Threaded Nails: 25mm 70mm in 5mm increments.
- · 4.0mm cannulated Hand Trauma Threaded Nails: 25mm 70mm in 5mm increments.
The system is provided non-sterile and is sterilized in the user facility.
Indications for Use
The Hand Trauma Threaded Nail System is indicated for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized threaded nail.
Summary of Technological Characteristics
The subject Hand Trauma Threaded Nail System is adding smaller sizes for the 2.0mm noncannulated and 3.0mm Cannulated Threaded Nails. These additional sizes do not present any new issues of safety or effectiveness as demonstrated by the Axial Pullout Strength testing presented in the performance testing section. The substantial equivalence of the Hand Trauma Threaded Nail System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging.
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Performance Testing
The addition of the smaller sizes for the 2.0mm Non-Cannulated Threaded Nails and the 3.0mm Cannulated threaded Nails was verified through an Axial Pullout Strength as it is the only testing affected by this change. The subject testing followed the FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway." The results demonstrated that the Skeletal Dynamics new Hand Trauma Threaded Nail Sizes are as safe and effective as the predicate device.
Conclusions
The substantial equivalence of the Skeletal Dynamic's Hand Trauma Threaded Nail System to the predicate device is demonstrated by similarities in indications for use, design (fundamental scientific technology), performance and operational principles, and does not present any new issues of safety or effectiveness. Thus, the subject Hand Trauma Threaded Nail System is an equivalent device to the Hand Trauma Screw System (K220723).