(22 days)
Not Found
No
The 510(k) summary describes a mechanical screw system and its intended uses, with no mention of AI or ML technology in the device description, intended use, or performance studies.
No
The device is described as a system for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies. These are surgical interventions rather than therapeutic treatments in the typical sense of a 'therapeutic device' which might involve ongoing treatment or therapy for a condition. It is a surgical implant for stabilization and repair.
No
The device is a headless compression screw system used for fixation of osseous fragments, fractures, arthrodesis of small joints, and osteotomies, which are therapeutic interventions, not diagnostic procedures.
No
The device description explicitly states it consists of cannulated titanium screws and specialized instrumentation, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The Skeletal Dynamics Headless Compression Screw System is a surgical implant used for fixing bones and joints within the body. It is a physical device used in surgical procedures, not for analyzing biological samples.
The information provided clearly describes a surgical implant and its intended use in orthopedic procedures, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include:
Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.
Product codes
HWC
Device Description
The Skeletal Dynamics Headless Compression Screw System consists of 2.5mm and 3.5mm cannulated titanium screws and specialized instrumentation. The screws are available in 11 length configurations between 10mm - 30mm, with increments of 2mm.
The system is provided non-sterile and is sterilized in the user facility.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Osseous fragments or fractures, small joints, scaphoid, lunate, capitate, trapezial, metacarpal, metatarsal, phalangeal, radial head, ulnar styloid, carpal, capitellum, distal radius, humeral head, glenoid, intercarpal, interphalangeal, tarsal, malleolar, patellar, odontoid, and mandibular.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Compression testing and ASTM F543 testing were performed to demonstrate conformance to the requirements. The subject device is as safe and effective as legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2015
Skeletal Dynamics, LLC Ana M. Escagedo President 8905 SW 87 Avenue, Suite 201 Miami, Florida 33176
Re: K143624
Trade/Device Name: 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: December 19, 2014 Received: December 22, 2014
Dear Ms. Ana M. Escagedo:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Ana M. Escagedo
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K143624
Device Name: Headless Compression Screw System
Indications For Use: The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include:
Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for Skeletal Dynamics. The logo consists of a stylized graphic to the left of the company name. The graphic is made up of four green shapes that are arranged to form a square. The company name, "skeletal dynamics", is written in a sans-serif font to the right of the graphic. The word "skeletal" is on the top line and the word "dynamics" is on the bottom line.
510(k) Summary of Safety and Effectiveness Skeletal Dynamics Headless Compression Screw System
December 19, 2014
Submitter:
Skeletal Dynamics. LLC 8905 SW 87 Avenue Suite 201 Miami, FL 33176 Tel: (305) 596-7585 Fax: (305) 596-7591 Contact: Ana M. Escagedo, President Email: aescagedo@skeletaldynamics.com
Establishment Registration Number: 3006742481
Trade Name, Common Name, Classification:
| Trade Names | Headless Compression Screw System |
|---|---|
| Common Name | Screw, fixation, bone |
| Classification | 21 CFR §888.3040 |
| Product Code | HWC |
| Class | Class II |
Predicate Devices:
Skeletal Dynamics Headless Bone Screw (K112672)
Description of the Device:
The Skeletal Dynamics Headless Compression Screw System consists of 2.5mm and 3.5mm cannulated titanium screws and specialized instrumentation. The screws are available in 11 length configurations between 10mm - 30mm, with increments of 2mm.
The system is provided non-sterile and is sterilized in the user facility.
Intended Use:
The Skeletal Dynamics Headless Compression Screw is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include:
Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius
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fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.
Summary of Technological Characteristics / Substantial Equivalence:
The substantial equivalence of the Skeletal Dynamics Headless Compression Screw System to the predicate device 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:
Compression testing and ASTM F543 testing were performed to demonstrate conformance to the requirements. The subject device is as safe and effective as legally marketed predicate devices.