(106 days)
The G3™ Active Plate® Large Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to <21 years) cases requiring stabilizations of mal-unions, non-unions, and osteotomies of long bones, as well as repair of closed, open and periprosthetic fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur, particularly in osteopenic bone.
The subject 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 stainless steel (316L) and medical grade titanium alloy (Ti-6Al-4V-ELI). 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 an elastomer sheath made from silicone 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.
Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies for the G3™ Active Plate® Large Fragment System.
It's important to note that this document is a 510(k) summary for a medical device (bone fixation system), not an AI/software as a medical device (SaMD) submission. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable to this type of device and submission. The "device" in this context is a physical orthopedic implant.
Acceptance Criteria and Study Details for G3™ Active Plate® Large Fragment System
1. Table of Acceptance Criteria and Reported Device Performance
For a physical orthopedic implant like the G3™ Active Plate® Large Fragment System, performance is measured against established mechanical standards rather than typical statistical metrics like sensitivity/specificity for AI. The acceptance criteria are implicit in meeting or exceeding the performance of predicate devices or established ASTM standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Stiffness (per ASTM F382 & F543 or equivalent) | "Mechanical testing, including stiffness... have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System... [and] have shown them to be substantially equivalent to the predicate plate and screw systems." Also, "the subject G3™ Active Plate® Large Fragment System has also demonstrated to be substantially equivalent in terms of construct stiffness performance when compared to the previously cleared reference devices K955848 and K962808." |
| Fatigue (per ASTM F382 & F543 or equivalent) | "Mechanical testing, including... fatigue... have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System... [and] have shown them to be substantially equivalent to the predicate plate and screw systems." Also, "the G3™ Active Plate® Large Fragment System has demonstrated to be substantially equivalent to the G3™ Active Plate Fragment System (K142938; S.E. 11/26/2014) in both fatigue and construct fatigue testing." |
| Pullout Strength (per ASTM F543 or equivalent, for screws) | "Mechanical testing, including... pullout... have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system, have shown them to be substantially equivalent to the predicate plate and screw systems." |
| Torsion (for screws) | "Mechanical testing, including... torsion... have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system, have shown them to be substantially equivalent to the predicate plate and screw systems." |
| Torque (for screws) | "Mechanical testing, including... torque... have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system, have shown them to be substantially equivalent to the predicate plate and screw systems." |
| Wear (for elastomer sheath) | "Mechanical testing, including... wear have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system, have shown them to be substantially equivalent to the predicate plate and screw systems." (Assuming 'wear' refers to the elastomer sheath's durability). |
| Biocompatibility | "In addition, a biocompatibility evaluation was conducted to demonstrate substantial equivalence to the predicate device." |
| Material Equivalence | The device uses "Titanium Alloy or Stainless Steel," which is "Identical" to the primary predicate material. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): The document does not specify exact "sample sizes" in terms of number of devices tested. For mechanical testing, samples are typically a set number of devices (e.g., 6 or 12 per test condition) to allow for statistical comparison to failure criteria or predicate performance. This information is usually detailed in the full test report, not the 510(k) summary.
- Data Provenance: The studies are mechanical laboratory tests performed on physical devices, not human subject data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This is a physical device submission undergoing mechanical testing, not a diagnostic or AI device requiring expert-established ground truth from clinical images or data. Performance is measured against engineering standards and against predicate device performance.
4. Adjudication Method for the Test Set
- Not Applicable. As this is mechanical testing of a physical device, there is no expert adjudication process for the test set. Results are quantitative measurements interpreted against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study is relevant for diagnostic performance, typically for imaging or other interpretation tasks performed by human readers. This is a physical orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This refers to AI/software performance. This device is a physical bone fixation system.
7. The Type of Ground Truth Used
- Engineering Standards and Predicate Device Performance: For mechanical testing, the "ground truth" is typically defined by:
- ASTM Standards: Established specifications for mechanical properties (e.g., minimum fatigue strength, stiffness range).
- Predicate Device Data: Performance data from an already legally marketed, substantially equivalent device that the new device aims to match or exceed.
- Not Applicable to pathology, outcomes data, or expert consensus in the human health context.
8. The Sample Size for the Training Set
- Not Applicable. This concept is for AI/machine learning models. For a physical device, there isn't a "training set" in the same sense. Design and material selection are based on engineering principles and prior knowledge, not iterative training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no "training set" for this physical device, this question is irrelevant.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with a flowing, ribbon-like element below.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2015
Genesis Fracture Care, Incorporated % Ms. Christine Scifert Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Bartlett, Tennessee 38133
Re: K152242 Trade/Device Name: G3™ 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 7, 2015 Received: October 9, 2015
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Ms. Christine Scifert
the quality systems (OS) 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" (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 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.
Lori A. Wiggins -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K152242
Device Name
G3TM Active Plate® Large Fragment System
Indications for Use (Describe)
The G3™ Active Plate® Large Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to <21 years) cases requiring stabilizations of mal-unions, and osteotomies of long bones, as well as repair of closed, open and periprosthetic fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur, particularly in osteopenic bone.
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)
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510(k) Summary
G3™ Active Plate® Large Fragment System November 23, 2015
| Company: | Genesis Fracture Care, Inc.13568 SE 97 th AveSuite 202Clackamas, OR 97015503-528-4048503-413-5216 (fax) |
|---|---|
| Primary Contact: | Christine Scifert |
| Company Contact: | Michael Bottlang |
| Trade Name: | G3 ™ Active Plate ® Large Fragment System |
| Common Name: | Plate, Fixation, BoneScrew, Fixation, Bone |
| Classification: | II |
| Regulation Number: | 888.3030 - Single/multiple component metallic bone fixation appliancesand accessories888.3040 - Smooth or threaded metallic bone fixation fastener |
| Panel: | 87-Orthopedic |
| Product Code(s): | HRS, HWC |
The subject G3™ Active Plate® Large Fragment System is a straight plate and Device Description: 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 stainless steel (316L) and medical grade titanium alloy (Ti-6Al-4V-ELI). 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 an elastomer sheath made from silicone 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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The G3TM Active Plate® Large Fragment system is intended for use in adult and Indications for Use: pediatric (subpopulation: transitional adolescent B (18 years to <21 years) cases requiring stabilizations of mal-unions, non-unions, and osteotomies of long bones, as well as repair of closed, open and periprosthetic fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur, particularly in osteopenic bone.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following plate and screw systems previously cleared by the FDA:
- Primary Predicate
- . Predicates:
- . Reference Devices:
In addition to being substantially equivalent in terms of intended use, geometry, and active feature the subject G3™ Active Plate® Large Fragment System has also demonstrated to be substantially equivalent in terms of construct stiffness performance when compared to the previously cleared reference devices K955848 and K962808. The subject G3™ Locking Screws have also demonstrated to be substantially equivalent to those in the previously cleared Zimmer Periarticular Locking Plate System (K042598; S.E. 10/29/2004) in terms of performance. Finally, the G3™ Active Plate® Large Fragment System has demonstrated to be substantially equivalent to the G3™ Active Plate Fragment System (K142938; S.E. 11/26/2014) in both fatigue and construct fatigue testing.
| Subject of Present 510(k): | Predicate Devices | |
|---|---|---|
| G3™ Active Plate™ | ||
| Intended Use/ Indicationsfor Use | The G3™ Active Plate® Large Fragmentsystem is intended for use in adult andpediatric (subpopulation: transitionaladolescent B (18 years to <21 years)cases requiring stabilizations of mal-unions, non-unions, and osteotomiesof long bones, as well as repair ofclosed, open and periprostheticfractures. The system is indicated for | Inclusive |
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| the fixation of long bone fracturesincluding but not limited to fracturesof the humerus, tibia, and femur, | ||
|---|---|---|
| particularly in osteopenic bone. | ||
| Primary Material | Titanium Alloy or Stainless Steel | Identical |
| Geometry and Dimensions | Plates: 6 - 14 holes; Lengths: 145 mm -305 mm | Plates: 2 - 24 holes; Lengths:56 mm - 444 mm |
| Locking Screws: Diameter: 5.0 mmLengths: 14 mm - 145 mm | Locking Screws: Diameter:4.0mm - 6.5 mmLengths: 10 mm - 130 mm |
Performance Testing: Mechanical testing, including stiffness, fatigue, pullout, torsion, torque, construct fatigue and wear have been performed per ASTM F543 and ASTM F382 on the subject G3™ Active Plate® Large Fragment System, as well as the G3™ locking screws used within the system, have shown them to be substantially equivalent to the predicate plate and screw systems. In addition, a biocompatibility evaluation was conducted to demonstrate substantial equivalence to the predicate device.
§ 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.