(59 days)
Null
No
The description focuses on the physical characteristics of the screws and standard mechanical testing, with no mention of AI or ML.
No
The device is described as a "Hand Trauma Screw System" for the "fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies," indicating it is an orthopedic implant for structural support rather than a device that provides therapy.
No
Explanation: The device is a system of screws for fixation of osseous fragments, fractures, arthrodesis, and osteotomies. Its intended use is therapeutic/surgical, not diagnostic.
No
The device description explicitly states that the system consists of titanium screws and specialized instrumentation, which are physical hardware components.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a system of titanium screws and instrumentation used for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies. This is a surgical device used directly on the patient's body for structural support and repair.
- No Mention of Samples or Testing: There is no mention of the device being used to analyze samples or perform any kind of diagnostic test.
The Hand Trauma Screw System is a surgical implant/device used for orthopedic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Hand Trauma Screw System is indicated for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Skeletal Dynamic's Hand Trauma Screw System consists of titanium screws and specialized instrumentation.
- 2.0mm non-cannulated Hand Trauma Screws: 24mm 48mm in 4mm increments.
- 3.0mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
- 3.5mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
- 4.0mm cannulated Hand Trauma Screws: 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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Engineering analysis and mechanical testing were conducted as recommended in the FDA guidance document, "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway," published in December 2020. Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamic's Hand Trauma Screw System is substantially equivalent to predicate devices currently marketed. Mechanical testing which established equivalency included ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws. Therefore, the subject device is as safe and effective as the legally marketed 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
May 12, 2022
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 Regulatory Affairs Specialist 7300 N Kendall Drive. Suite 400 Miami, Florida 33156
Re: K220723
Trade/Device Name: Hand Trauma Screw 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 11, 2022 Received: March 14, 2022
Dear Alexandra Rodriguez:
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
1
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, 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) K220723
Device Name Hand Trauma Screw System
Indications for Use (Describe)
The Hand Trauma Screw System is indicated for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw.
| 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 Skeletal Dvnamic's Hand Trauma Screw System
Submitter
Skeletal Dvnamics. Inc. 7300 N. Kendall Drive Suite 400 Miami, FL 33156 Phone: 305-596-7585 Facsimile: 305-596-7591 Contact Person: Alexandra Rodriguez Date Prepared: March 14, 2022
Name and Classification
Trade Name: Hand Trauma Screw 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
Primary predicate device: REDUCT® Headless Compression Screw, K201662 Additional predicate device: Tyber Medical Trauma Screws, K133842
Device Description
The Skeletal Dynamic's Hand Trauma Screw System consists of titanium screws and specialized instrumentation.
- 2.0mm non-cannulated Hand Trauma Screws: 24mm 48mm in 4mm increments. ●
- 3.0mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
- 3.5mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
- 4.0mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
The system is provided non-sterile and is sterilized in the user facility.
Indications for Use
The Hand Trauma Screw System is indicated for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw.
Summary of Technological Characteristics
The substantial equivalence of the Hand Trauma Screw System to the predicate 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
Engineering analysis and mechanical testing were conducted as recommended in the FDA guidance document, "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway," published in December 2020. Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamic's Hand Trauma Screw System is substantially equivalent to predicate devices currently marketed. Mechanical testing which established equivalency included ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws. Therefore, the subject device is as safe and effective as the legally marketed predicate device.
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Conclusions
The Skeletal Dynamic's Hand Trauma Screw System is substantially equivalent to the predicate devices identified in this premarket notification.