(46 days)
Not Found
No
The device description focuses on mechanical components (plates, screws, sliding elements) and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical tests, not evaluations of algorithmic performance.
Yes.
The device is intended for the "stabilizations of mal-unions, and osteotomies of long bones, as well as repair of closed and open fractures" and "fixation of long bone fractures", which are therapeutic interventions.
No
The device is described as a surgical implant system (plate and screws) used for fracture fixation and stabilization of mal-unions and osteotomies, which are therapeutic interventions, not diagnostic procedures.
No
The device description explicitly states that the system is comprised of physical components made from medical grade stainless steel and silicone elastomer, including plates and screws. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stabilizations of mal-unions, and osteotomies of long bones, as well as repair of closed and open fractures." This describes a surgical implant used to fix bones.
- Device Description: The description details a "straight plate and locking screw system" made of medical grade stainless steel and silicone elastomer. This is consistent with a surgical implant, not a diagnostic device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a physiological or pathological state
- Being used in a laboratory setting
The device is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The G3™ Active Plate® Small Fragment 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2016
Genesis Fracture Care, Incorporated % Ms. Christine Scifert Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Bartlett, Tennessee 38133
Re: K160633
Trade/Device Name: G3™ Active Plate® Small 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: March 4, 2016 Received: March 7, 2016
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
G3TM Active Plate® Small Fragment System
Indications for Use (Describe)
The G3™ Acive Plate® Small Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to ™ Active Plate ® Small 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 |
The G3TM Active Plate® Small Fragment System is a straight plate and locking Device Description: screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plate and screw are intended to be used for fracture fixation. All implantable components are manufactured from medical grade stainless steel and silicone elastomer the same as the subject device. The screws are 3.5 mm diameter and come in lengths ranging from 10 to 90 mm. The plates range in size from 6 hole to 18 hole. The plates incorporate sliding elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to the 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.
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Indications for Use: The G3™ Active Plate® Large Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years)) cases requiring stabilizations of mal-unions, non-unions, and osteotomies of long bones, as well as repair of closed and open fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, fibula, and radius.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following plate and screw systems previously cleared by the FDA:
- Zimmer® Universal Locking System (K060710; S.E.4/26/2006)
- Zimmer® MotionLoc™ Screw for Periarticular Locking Plate System (K130810; S.E. 9/19/2013)
- Smith & Nephew Locking Bone Plate System (K033669; S.E. 12/10/2003 and K083032, S.E. ● 01/07/2009)
- Genesis Fracture Care G3™ Active Plate® Large Fragment System (K152242; S.E. 11/24/2015)
- Genesis Fracture Care G3™ Active Plate® Large Fragment System (K142938; S.E. 11/26/2014)
In addition to being substantially equivalent in terms of intended use, materials, geometry, and active feature, the subject G3™ Active Plate® Small Fragment System has also demonstrated to be substantially equivalent in terms of construct stiffness performance when compared to the previously cleared titanium G3™ Active Plate Large Fragment System (K152242, S.E. 11/24/2015). The subject G3™ Locking Screws have also demonstrated to be substantially equivalent to those in the previously cleared Zimmer Universal Locking System (K060710; S.E. 04/26/2006) in terms of performance. Finally, the G3™ Active Plate® Small Fragment System has demonstrated to be substantially equivalent to the 3.5mm Zimmer® MotionLoc ™ Universal Plating System (Stainless Steel – K060710; S.E. 04/26/2006) in fatigue and Smith & Nephew PERI-LOC Bone Plating and Screw System (K033669, S.E. 12/10/2003 and K083032, S.E. 01/07/2009) and 3.5mm Zimmer® MotionLoc ™ Universal Plating System (Stainless Steel – K060710; S.E. 04/26/2006) in construct fatigue testing.
| Subject of Present 510(k): | Predicate Devices | |
|---|---|---|
| G3™ Active Plate™ | ||
| Intended Use/ Indications | ||
| for Use | The G3™ Active Plate® Small Fragment | |
| system is intended for use in adult and | ||
| pediatric (subpopulation: transitional | ||
| adolescent B (18 years to |