(28 days)
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.
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.
I am sorry, but the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter and summary for a medical device (Hand Trauma Threaded Nail System), which primarily addresses substantial equivalence to a predicate device based on similar indications for use, design, materials, and performance.
The "Performance Testing" section mentions that "Axial Pullout Strength" testing was performed to verify the addition of smaller sizes, and that this testing followed FDA guidance. It concludes that the new sizes are "as safe and effective as the predicate device." However, specific acceptance criteria for this test and detailed results are not provided in the given text.
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study to prove they are met, including sample sizes, ground truth establishment, or expert involvement, as this information is not present in the input.
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April 28, 2023
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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
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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,
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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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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).
§ 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.