(266 days)
The Extremity Medical External Fixation System is indicated for adults and pediatric patients (2 years old and older) for treatment of:
Open and closed fractures
Osteotomies
Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Pseudoarthrosis, infected union, non-union, or malunion of long bones
Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
Correction of bony or soft tissue deformity (orthoplastic surgery)
Joint arthrodesis
Infected fractures
Correction of segmental bony or soft tissue defects
Management of comminuted intra-articular fractures
Bone transport
Revision procedures where other treatments or devices have been unsuccessful
Bone reconstruction procedures
Charcot foot reconstruction
Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
Ankle distraction (arthrodiastasis)
Septic fusion
The Extremity Medical External Fixation System consists of three basic types of elements: bridge elements, connection elements and bone anchorage elements. The system is intended for use in a variety of applications including but not limited to Charcot foot reconstruction, open fracture fixation, joint arthrodesis, limb lengthening and bone transport. The assembly is made up of two or more circular rings that are connected by struts, rods or pillars to provide a framework for fixation. Pins and tensioned wires are then used to fixate and stabilize bones and joints.
Bridge elements include rings, manufactured from anodized aluminum, in various types and sizes to accommodate varying patient anatomy. Connection elements, manufactured from stainless steel and anodized aluminum, include threaded rods and threaded pillars available in multiple lengths and struts available in multiple sizes. Bone anchorage elements include wires and half pins, manufactured from stainless steel, available in multiple diameters and lengths.
All External Fixation components are for single use only.
The original document is a 510(k) summary for the Extremity Medical External Fixation System. It describes a medical device, its indications for use, and a comparison to predicate devices, focusing on non-clinical testing for substantial equivalence.
It does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria. The document focuses on the substantial equivalence of a physical external fixation system through engineering analysis and static/dynamic construct testing, not on the performance of a software algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/SaMD from this document. The sections you asked about, such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not relevant to the content of this 510(k) summary for a physical medical device.
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February 21, 2025
Extremity Medical, LLC Mary Hoffman Director of Quality Assurance and Regulatory Affairs 300 Interpace Parkway Building A. 2nd Floor Parsippany, New Jersey 07054
Re: K241563
Trade/Device Name: Extremity Medical External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: May 31, 2024 Received: January 22, 2025
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
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assistance/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,
Lixin Liu -S
Lixin Liu, Ph.D Assistant Director DHT6A: Division of Joint Arthroplasty 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) K241563
Device Name
Extremity Medical External Fixation System
Indications for Use (Describe)
The Extremity Medical External Fixation System is indicated for adults and pediatric patients (2 years old and older) for treatment of:
- Open and closed fractures
- · Osteotomies
· Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- · Pseudoarthrosis, infected union, non-union, or malunion of long bones
- · Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
- · Correction of bony or soft tissue deformity (orthoplastic surgery)
- · Joint arthrodesis
- · Infected fractures
- · Correction of segmental bony or soft tissue defects
- · Management of comminuted intra-articular fractures
- · Bone transport
- · Revision procedures where other treatments or devices have been unsuccessful
- Bone reconstruction procedures
- · Charcot foot reconstruction
- · Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
- · Ankle distraction (arthrodiastasis)
- · Septic fusion
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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K241563 (Page 1 of 3)
Traditional 510(k) Summary:
External Fixation System
| Submitter | Extremity Medical, LLC300 Interpace ParkwayBuilding A, 2nd FloorParsippany, NJ 07054 |
|---|---|
| Contact Person | Mary Hoffman, MSDirector, Quality Assurance and Regulatory AffairsPhone: (973) 588-8980 ext. 502Email: mhoffman@extremitymedical.com |
| Date Prepared | February 20, 2025 |
| Trade Name | Extremity Medical External Fixation System |
| ClassificationName andNumber | 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances andaccessories |
| Product Code | KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component) |
| PrimaryPredicate | K201253- Smith & Nephew Ilizarov External Fixator |
| AdditionalPredicates | K232838 - Paragon 28 Monkey Rings External Fixation SystemK161417 - Depuy Synthes Maxframe Multi-Axial Correction System |
| DeviceDescription | The Extremity Medical External Fixation System consists of three basic types of elements:bridge elements, connection elements and bone anchorage elements. The system is intendedfor use in a variety of applications including but not limited to Charcot foot reconstruction,open fracture fixation, joint arthrodesis, limb lengthening and bone transport. The assemblyis made up of two or more circular rings that are connected by struts, rods or pillars toprovide a framework for fixation. Pins and tensioned wires are then used to fixate andstabilize bones and joints.Bridge elements include rings, manufactured from anodized aluminum, in various types andsizes to accommodate varying patient anatomy. Connection elements, manufactured fromstainless steel and anodized aluminum, include threaded rods and threaded pillars availablein multiple lengths and struts available in multiple sizes. Bone anchorage elements includewires and half pins, manufactured from stainless steel, available in multiple diameters andlengths.All External Fixation components are for single use only. |
| Indications foruse | The Extremity Medical External Fixation System is indicated for adults and pediatricpatients (2 years old and older) for treatment of:Open and closed fractures Osteotomies Fractures and disease which generally may result in joint contractures or loss ofrange of motion and fractures requiring distraction Pseudoarthrosis, infected union, non-union, or malunion of long bones Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction Correction of bony or soft tissue deformity (orthoplastic surgery) Joint arthrodesis Infected fractures Correction of segmental bony or soft tissue defects Management of comminuted intra-articular fractures Bone transport Revision procedures where other treatments or devices have been unsuccessful Bone reconstruction procedures Charcot foot reconstruction Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle Ankle distraction (arthrodiastasis) Septic fusion |
| Statement ofTechnologicalComparison | The Extremity Medical External Fixation System and predicate devices are substantiallyequivalent in terms of design, material, mechanical properties and indications for use.The subject and predicate are based on the following same technological elements:Implants (wires and half pins) are used temporarily to stabilize bones and/or jointsand are fixed to external ring components via hardware. Bridge elements are used external to the body and are fixed to bone via implants. Connection elements (threaded rods, threaded pillars and struts) are used to connectrings to other rings. Connection elements (hardware) are used to fix wires to rings, fix half pins to rings,connect struts/rods/pillars to rings, and to connect walking attachments to rings. Walking attachment components are connected to the bottom of foot rings viahardware which are used for weight bearing and walking purposes. All subject and predicate devices are made of the same materials (Stainless Steel,Aluminum 6061-T6, Plastic (Delrin, Radel), Rubber) and thus have equivalentmechanical properties. Key differences in design of the subject device compared to the predicate are as follows: Subject bridge elements (rings) provide a double row of holes versus" tabbed"mounting options, along with olive wire mounting options. Subject bridge elements (foot rings) include tapped holes for the option to directlyattach bolts while also allowing for the combination of nuts and bolts to be used. They also include an anatomic option to match the foot shape. |
| Subject accessories provide options for foot rocker or sole style versus “rocker ring” or “foot ring” only. These differences in design do not introduce different issues of safety or effectiveness. | |
| Non-clinicalTesting | The Extremity Medical External Fixation System components were compared to the predicates by engineering analysis and static and dynamic construct testing in accordance with ASTM F1541-17.The results of this analysis indicate that the Extremity Medical External Fixation System is substantially equivalent to predicate devices and does not introduce different issues of safety or effectiveness. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The Extremity Medical External Fixation System is substantially equivalent to its predicate devices. This conclusion is based upon indications for use, principles of operation, design, engineering analysis, and static and dynamic construct testing. |
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.