(174 days)
No
The description focuses on the mechanical design and materials of the plate and screw system for fracture fixation. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is used for fracture fixation, which is a medical treatment aimed at restoring the function and structure of fractured bones.
No
Explanation: The device, the G3™ Active Plate® Miniature System, is intended for fracture fixation and stabilization, which is a therapeutic purpose, not a diagnostic one. Its function involves providing structural support for bones, rather than identifying or characterizing diseases or conditions.
No
The device description explicitly states that the system includes implantable components manufactured from medical grade titanium alloy, cobalt chrome alloy, and silicone elastomer, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fracture fixation in patients... requiring stabilization of mal-unions, osteotomies and repair of closed and open fractures in small bones." This describes a surgical implant used to physically stabilize bone fractures.
- Device Description: The description details a "straight plate and locking screw system" made of medical grade materials, designed to be implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The G3™ Active Plate® Miniature System is intended for fracture fixation in patients 18 years of age and older requiring stabilization of mal-unions, osteotomies and repair of closed and open fractures in small bones. The system is indicated for the fixation of small bone fractures including, but not limited to, fractures of the hand, foot, wrist and ankle.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The G3™ Active Plate® Miniature System is a straight plate and locking screw system intended to be used for fracture fixation of the hand and foot. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI), medical grade cobalt chrome alloy (Co-28Cr-6Mo) and silicone elastomer in the subject device.
The plate has 8 holes. The plates incorporate link elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to both the link element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. The screws are 1.5 mm diameter and come in lengths ranging from 8 mm to 24 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bone fractures including, but not limited to, fractures of the hand, foot, wrist and ankle.
Indicated Patient Age Range
18 years of age and older
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing including axial, torsional and shear stiffness and fourpoint bend per ASTM F382-08 was performed on the subject G3™ Active Plate® Miniature System and the results show the subject plates to be substantially equivalent to the predicate devices. Engineering analysis was used to compare the torsional strength, axial pullout strength and insertion/removal torque of the subject screws to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061748, K141527, K083364, K051605, K132895
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
Genesis Fracture Care, Inc. % Christine Scifert Managing Partner MRC-X, LLC 6075 Poplar Ave Suite 500 Memphis, Tennessee 38119 October 23, 2017
Re: K171293
Trade/Device Name: G3TM Active Plate® Miniature 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: September 18, 2017 Received: September 21, 2017
Dear Christine 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 of medical 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
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 (DICE) 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" (21 CFR 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 (DICE) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
G3TM Active Plate® Miniature System
Indications for Use (Describe)
The G3™ Active Plate® Miniature System is intended for fracture fixation in patients 18 years of age and older requiring stabilization of mal-unions, osteotomies and repair of closed and open fractures in small bones. The system is indicated for the fixation of small bone fractures including, but not limited to, fractures of the hand, foot, wrist and ankle.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
K171293 Page 1/3
510(k) Summary G3™ Active Plate® Miniature System September 18, 2017
| 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® Miniature 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 G3™ Active Plate® Miniature System is a straight plate and locking screw Device Description: system intended to be used for fracture fixation of the hand and foot. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI), medical grade cobalt chrome alloy (Co-28Cr-6Mo) and silicone elastomer in the subject device.
The plate has 8 holes. The plates incorporate link elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to both the link element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. The screws are 1.5 mm diameter and come in lengths ranging from 8 mm to 24 mm.
4
Indications for Use: The G3™ Active Plate® Miniature System is intended for fracture fixation in patients 18 years of age and older requiring stabilization of mal-unions, osteotomies and repair of closed and open fractures in small bones. The system is indicated for the fixation of small bone fractures including, but not limited to, fractures of the hand, foot, wrist and ankle.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
Primary Predicate
-
Hand Innovations (Zimmer Biomet Inc.) Mini Fragment Plates (K061748) ●
Additional Predicates -
DePuy Synthes Variable Angle Locking Hand System (K141527) ●
-
DePuy Synthes - Small Bone Locking Plating System (K083364)
-
Small Bone Innovations SBI K-Wires (K051605) ●
-
. Wright Medical - WMT Implantable K-wires (K132895)
Reference Devices
- Genesis Fracture Care (Zimmer Biomet Inc.) G3™ Active Plate® Large Fragment . System (K152242)
The subject G3™ Active Plate® Miniature System has demonstrated to be substantially equivalent to the predicates as the products are similar in indications, materials, geometry, and active feature.
| | Subject of Present 510(k):
G3 TM Active Plate® Miniature Plate | Predicate Devices |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Intended Use/ Indications
for Use | The G3 TM Active Plate® Miniature
System is intended for fracture fixation
in patients 18 years of age and older
requiring stabilization of mal-unions,
non-unions, osteotomies and repair of
closed and open fractures in small
bones. The system is indicated for the
fixation of small bone fractures | Inclusive |
5
| including, but not limited to, fractures of the hand, foot, wrist and ankle. | ||
|---|---|---|
| Materials | Titanium Alloy (Plate) | |
| Silicone – NuSil (Plate) | ||
| Cobalt Chrome (Screws) | Identical | |
| Geometry and Dimensions | Plates: 8 holes | |
| Length: 25 mm | ||
| Locking Screws: | ||
| Diameter: 1.5mm | ||
| Lengths: 8 mm – 24 mm | Inclusive |
Performance Testing: Mechanical testing including axial, torsional and shear stiffness and fourpoint bend per ASTM F382-08 was performed on the subject G3™ Active Plate® Miniature System and the results show the subject plates to be substantially equivalent to the predicate devices. Engineering analysis was used to compare the torsional strength, axial pullout strength and insertion/removal torque of the subject screws to the predicates.
Conclusion
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predict devices.