(48 days)
No
The device description focuses on mechanical components (plates, screws, sliding elements, silicone elastomer) and materials (titanium alloy, silicone elastomer, stainless steel). There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies described are mechanical and biocompatibility tests, not evaluations of algorithmic performance.
Yes.
The device is intended for the stabilization and repair of fractures and osteotomies of long bones, which are therapeutic interventions.
No
Explanation: The device is described as a surgical implant (plate and screw system) used for the fixation of long bone fractures, specifically for stabilization of mal-unions, non-unions, osteotomies, and repair of fractures. Its function is to provide mechanical support, not to diagnose a condition.
No
The device description explicitly states it is a "straight plate and locking screw system" comprised of physical components made from titanium alloy and silicone elastomer, and includes instruments made from stainless steel. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the G3™ Active Plate® Large Fragment System is a system of plates and screws intended for the fixation of long bone fractures. These are implantable components used directly within the body to stabilize bones.
- Intended Use: The intended use is for the stabilization and repair of bone fractures and osteotomies. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic procedures.
Therefore, the G3™ Active Plate® Large Fragment System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2014
Genesis Fracture Care, Incorporated % Ms. Christine Scifert Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133
Re: K142938
Trade/Device Name: G3TM Active Plate® Large Fragment System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 8, 2014 Received: October 9, 2014
Dear Ms. Scifert:
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 (reporting of medical
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Page 2 - Ms. Christine Scifert
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 yours.
Vincent J. Devlin -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)
Device Name
G3TM Active Plate® Large Fragment System
Indications for Use (Describe)
The system is intended for use in adult and pediation: transitional adolescent B (18 years to Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
G3™ Active Plate® Large Fragment System November 21, 2014
| Company: | Genesis Fracture Care, Inc.
13568 SE 97th Ave
Suite 202
Clackamas, OR 97015
503-528-4048
503-413-5216 (fax) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Company Contact: | Michael Bottlang |
| Trade Name: | G3 ™ Active Plate ® Large Fragment System |
| Common Name: | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Classification: | II |
| Regulation Number: | 888.3030 - Single/multiple component metallic bone fixation appliances and accessories
888.3040 - Smooth or threaded metallic bone fixation fastener |
| Panel: | 87-Orthopedic |
| Product Code(s): | HRS, HWC |
| Device Description: | The G3 ™ Active Plate ® Large Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plates and screws are intended to be used for long bone fracture fixation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and silicone elastomer in the subject device. The screws are 5.0 mm diameter and come in lengths ranging from 14 to 145 mm. The plates range in size from 6 holes to 14 holes. The plates incorporate sliding elements, which are constrained within the plate and |
embedded in a silicone elastomer sheath that is bonded to both the plate and
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sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.
Indications for Use: The system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to