(27 days)
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No
The 510(k) summary describes a system of bone screws and associated instrumentation, focusing on mechanical properties and performance testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is described as a "Headless Compression Screw System" intended for "fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies," which are medical treatments for skeletal issues.
No
The device is described as a "Headless Compression Screw System" intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies. This indicates it is a surgical implant used for treatment, not for diagnosing conditions.
No
The device description explicitly states it consists of physical screws made from titanium alloy and includes appropriate instrumentation, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This includes tests for diseases, conditions, or to monitor treatments.
- Device Description and Intended Use: The provided text clearly describes a system of screws made of titanium alloy intended for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies. These are surgical procedures performed directly on the body, not tests performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analysis of biological samples, which are hallmarks of IVD devices.
This device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Skeletal Dynamics REDUCT® Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw.
Product codes
HWC
Device Description
The REDUCT® Headless Compression Screw (HCS) System consists of the following screws from medical grade Titanium Alloy (ASTM F136).
- · 2.5mm cannulated HCS screws: 10mm 30mm
- 3.5mm cannulated HCS screws: 10mm 50mm
- 4.5mm cannulated HCS screws: 20mm 65mm
- · 2.0mm non-cannulated HCS Arthrodesis screws: 20mm 34mm
- 2.5mm cannulated HCS Arthrodesis screws: 26mm 40mm
- 3.5mm cannulated HCS Arthrodesis screws: 32mm 46mm
The REDUCT® Headless Compression Screw includes appropriate instrumentation, as identified in the surgical technique.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
For confirmation of substantial equivalence, performance testing was completed in accordance with ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws, including self-tap force, insertion torque testing, removal torque testing, torsional strength testing and pullout strength testing. Additionally bending strength and fatigue bending strength was completed in accordance to ASTM F2193, Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System. This testing demonstrates the modified HCS Screws are substantially equivalent to the predicate devices and present no new issues of safety or effectiveness compared to the predicate device.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
July 16, 20202
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Skeletal Dynamics, Inc. Diana Taylor Senior Regulatory Affairs Specialist 7300 N. Kendall Drive, Suite 400 Miami, Florida 33156
Re: K201662
Trade/Device Name: REDUCT® Headless Compression 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: June 17, 2020 Received: June 19, 2020
Dear Diana Taylor:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
for
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
2
510(k) Number (if known) K201662 Device Name
REDUCT® Headless Compression Screw System
Indications for Use (Describe)
The Skeletal Dynamics REDUCT® Headless Compression Screw System is intended for 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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3
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510(k) SUMMARY
REDUCT® Headless Compression Screw System
Submitter
Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami, FL 33156 Phone: 305-596-7585 Facsimile: 305-596-7591 Contact Person: Diana Taylor Date: July 16, 2020
Name and Classification
Name: REDUCT® Headless Compression Screw System Common Name: Screw, Fixation, Bone Classification: 21 CFR §888.3040 Requlatory Class: Class II Product Code(s): HWC
Predicate Device: K143624, 1/13/2015 Skeletal Dynamics Headless Compression Screw System
Device Description
The REDUCT® Headless Compression Screw (HCS) System consists of the following screws from medical grade Titanium Alloy (ASTM F136).
- · 2.5mm cannulated HCS screws: 10mm 30mm
- 3.5mm cannulated HCS screws: 10mm 50mm
- 4.5mm cannulated HCS screws: 20mm 65mm
- · 2.0mm non-cannulated HCS Arthrodesis screws: 20mm 34mm
- 2.5mm cannulated HCS Arthrodesis screws: 26mm 40mm
- 3.5mm cannulated HCS Arthrodesis screws: 32mm 46mm
The REDUCT® Headless Compression Screw includes appropriate instrumentation, as identified in the surgical technique.
Indications for Use
The Skeletal Dynamics REDUCT® Headless Compression Screw System is intended 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 modified and predicate HCS Screws is demonstrated by similarities in intended use, indications for use, same materials, sterility and packaging, similar thread design, diameters and lengths. The differences include new smaller and larger diameter screws and additional lengths in existing diameters, and HCS Screws specific for the use in Arthrodesis.
Performance Testing
For confirmation of substantial equivalence, performance testing was completed in accordance with ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws, including self-tap force, insertion torque testing, removal torque testing, torsional strength testing and pullout strength testing. Additionally bending strength and fatigue bending strength was completed in accordance to ASTM F2193, Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System. This testing demonstrates the modified HCS Screws are substantially equivalent to the predicate devices and present no new issues of safety or effectiveness compared to the predicate device.
Conclusions
The subject REDUCT® Headless Compression Screws are equivalent to the legally marketed predicate and present no new issues of safety or effectiveness.