(28 days)
The Intraosseous Fixation System is intended for reduction of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the hand, wrist, foot and ankle, appropriate for the size of the device.
The Extremity Medical Intraosseous Fixation System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunion of the small bones and joints of the hand, wrist, foot, and ankle. The system consists of solid and cannulated screws, with the option of adding Washers; a standard/flat Washer, a Washer Post (referred to as an X-Post) for engaging the head of the Screw, and an X-Clip for engaging the threads of the screw. The X-Post/X-Clip come in varying sizes and lengths. Similarly, the lag screws come in varying diameters and lengths, and are also available in short and long thread configurations. The modified device is a product line extension and improvement to the Screw and Washer System, cleared under K121349, intended to provide modularity to the end user. New components to the system consist of cannulated 3.5 mm screws and implant accessories, X-Posts and X-Clips, to offer surgeons options for placement. Additionally, the system will offer additional thread length options for the 4.5mm screws cleared under K121349 and 6.5mm screws substantially equivalent to those cleared under K121349.
This document, K201556, pertains to a 510(k) premarket notification for a medical device called the "Intraosseous Fixation System," manufactured by Extremity Medical, LLC. It is a Class II device (21 CFR 888.3040) classified as a smooth or threaded metallic bone fixation fastener.
The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria for software or an AI/ML algorithm. The document describes a traditional medical device (implants for bone fixation) and its substantial equivalence to predicate devices based on design, materials, and mechanical properties. There is no mention of an AI/ML component, image analysis, or any performance metrics typically associated with such systems.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, test set details, ground truth establishment, or human reader studies related to an AI/ML device, as none of that information is present in the provided FDA 510(k) clearance document.
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July 8, 2020
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Extremity Medical, LLC. Mary Hoffman Manager. Ouality Assurance and Regulatory Affairs 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K201556
Trade/Device Name: Intraosseous Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC. HTN Dated: June 9, 2020 Received: June 10, 2020
Dear Mary Hoffman:
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
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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,
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201556
Device Name Intraosseous Fixation System
Indications for Use (Describe)
The Intraosseous Fixation System is intended for reduction of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the hand, wrist, foot and ankle, appropriate for the size of the device.
| 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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Special 510(k) Summary of Safety and Effectiveness:
| Submitter | Extremity Medical, LLC300 Interpace Parkway, Suite 410Parsippany, NJ 07054 |
|---|---|
| Contact Person | Mary Hoffman, MSManager, Quality Assurance and Regulatory AffairsPhone: (973) 588-8980Email: mhoffman@extremitymedical.com |
| Date Prepared | July 8, 2020 |
| Trade Name | Intraosseous Fixation System |
| ClassificationName andNumber | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener (PrimaryClassification);21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances andaccessories |
| Product Code | HWC (screw, fixation, bone); HTN (washer, bolt, nut) |
| PrimaryPredicate | K121349 - Extremity Medical Screw and Washer System |
| AdditionalPredicates | K101700 - Extremity Medical Screw and Washer SystemK171018 – Axis Charcot Fixation SystemK124027 – Paragon 28 Monster Screw System |
| ReferenceDevice | K173347 - STALIF FLX, Intervertebral Fusion Device |
| DeviceDescription | The Extremity Medical Intraosseous Fixation System is intended for reduction and internalfixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunion of thesmall bones and joints of the hand, wrist, foot, and ankle. The system consists of solid andcannulated screws, with the option of adding Washers; a standard/flat Washer, a WasherPost (referred to as an X-Post) for engaging the head of the Screw, and an X-Clip forengaging the threads of the screw. The X-Post/X-Clip come in varying sizes and lengths.Similarly, the lag screws come in varying diameters and lengths, and are also available inshort and long thread configurations. The modified device is a product line extension andimprovement to the Screw and Washer System, cleared under K121349, intended to providemodularity to the end user. New components to the system consist of cannulated 3.5 mmscrews and implant accessories, X-Posts and X-Clips, to offer surgeons options forplacement. Additionally, the system will offer additional thread length options for the4.5mm screws cleared under K121349 and 6.5mm screws substantially equivalent to thosecleared under K121349. |
| Indications foruse | The Intraosseous Fixation System is intended for reduction and internal fixation ofarthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the smallbones and joints of the hand, wrist, foot and ankle, appropriate for the size of the device. |
| Statement ofTechnologicalComparison | The Intraosseous Fixation System and predicate devices are equivalent in terms of designand material mechanical properties, and similar in indications for use. |
| The subject and predicate devices are based on the following same technological elements:Implants are used temporarily to generate compression across the joint/bone that is being repaired/reconstructed.Devices are made of the same material (Ti-6Al-4V ELI per ASTM F3001 and F136).Implants utilize a crossing relationship to create perpendicular compression through the interaction of a lag screw and washer-style components. | |
| The following technological differences exist between the subject and predicate devices:The predicate device is a one or two part construct, whereas the subject device is a one to three part construct, depending on surgeon preference and patient anatomy.Use of different instrumentation specific to implantation of the optional accessories (X-Posts and X-Clips).X-Post and X-Clip geometry modified for reduced profile and required bone removal. Washers introduced to further the versatility of the system. | |
| The differences in the design of the subject device as compared to predicates do not introduce new issues of safety or effectiveness. | |
| Non-clinicalTesting |
Intraosseous Fixation System
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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.