(86 days)
Not Found
No
The summary describes a mechanical orthopedic plating system and its components, with no mention of software, algorithms, or any features indicative of AI/ML. The performance studies are mechanical tests, not related to data analysis or image processing.
Yes
The device is intended for trauma and reconstructive procedures, which are therapeutic interventions aimed at repairing or restoring damaged tissues or structures.
No
This device is a plating system used for trauma and reconstructive procedures, not for diagnosing conditions.
No
The device description explicitly states it consists of plates, screws, olive wires, guide wires, and instruments, which are all hardware components.
Based on the provided information, the Gridlock Ankle Plating System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "trauma and reconstructive procedures of the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device." This describes a surgical implant and associated instruments used directly on a patient's body for treatment.
- Device Description: The description details plates, screws, and instruments used for orthopedic procedures. These are physical devices implanted or used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. The Gridlock Ankle Plating System does not perform this function. It is a therapeutic device.
Therefore, the Gridlock Ankle Plating System is a surgical implant and instrument system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Gridlock Ankle Plating System is intended for use in trauma and reconstructive procedures of the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device.
The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HRS,HWC
Device Description
Gridlock Ankle Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device.
Indicated Patient Age Range
Not Found
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)
Non-clinical Test Summary: The following analyses were conducted:
Screw Torque to Failure (ASTM F543)
Plate 4-Point Bending (ASTM F382)
The results of these evaluations indicate that the Gridlock Ankle Plating System is equivalent to predicate devices.
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.
K143385, K102429, K121452, K040860
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.
Not Found
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/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 a stylized image of three human profiles facing to the right, with a triple helix-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2016
Trilliant Surgical, Limited % Mr. J.D. Webb President The Orthomedix Group, Incorporated 1001 Oakwood Boulevard Round Rock. Texas 78681
Re: K160177
Trade/Device Name: Gridlock Ankle Plating 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: January 23, 2016 Received: January 27, 2016
Dear Mr. Webb:
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
1
Page 2 - Mr. J.D. Webb
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Gridlock Ankle Plating System
Indications for Use (Describe)
The Gridlock Ankle Plating System is intended for use in trauma and reconstructive procedures of the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device.
The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
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
510(k) Summary: Gridlock Ankle Plating System
| Date Prepared | April 19, 2016 |
|---|---|
| Submitted By | Trilliant Surgical LTD |
| 6721 Portwest Dr, Suite 160 | |
| Houston, TX 77024 | |
| 1-800-495-2919 Tele | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| 512-692-3699 Fax | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | Gridlock Ankle Plating System |
| Common Name | bone plate & screws |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories |
| Smooth or threaded metallic bone fixation fastener | |
| Class | II |
| Product Code | HRS / HWC |
| CFR Section | 21 CFR section 888.3030 / 888.3040 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Acumed Ankle Plating System (K143385) |
| Secondary Predicate | |
| Devices | Wright ORTHOLOC® 3Di Ankle Fracture System (K102429) |
| Gridlock Plating System (K121452) | |
| Integra Cannulated Screw System (K040860) | |
| Device Description | Gridlock Ankle Plating System consists of various shape and size plates for the |
| management of orthopedic osteotomies, reconstruction, and trauma. Features | |
| include a low profile, limited contact, capability of dynamic/manual compression, | |
| and angulated-locking threaded screw holes. The system also consists of multiple | |
| locking/standard screw lengths and diameters and the necessary instruments to | |
| facilitate the placement of these implants. | |
| Materials | CP Titanium per ASTM F67 |
| Titanium alloy (Ti-6Al-4V) per ASTM F136 | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The Gridlock Ankle Plating System is substantially equivalent to the predicate |
| devices in terms of intended use, design, materials used, mechanical safety and | |
| performances. | |
| Indications for Use | The Gridlock Ankle Plating System is intended for use in trauma and reconstructive |
| procedures of the small bones in the hand/foot, ankle, distal tibia, fibula, and other | |
| bones appropriate for the size of the device. | |
| The plates (implant), screws (implant), washers (implant), olive wires (instrument), | |
| and guide wires (instrument) are intended for single use only. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| Screw Torque to Failure (ASTM F543) | |
| Plate 4-Point Bending (ASTM F382) | |
| The results of these evaluations indicate that the Gridlock Ankle Plating System is | |
| equivalent to predicate devices. | |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non- | |
| clinical and Clinical | Trilliant Medical LTD considers Gridlock Ankle Plating System to be equivalent to |
| the predicate devices listed above. This conclusion is based upon the devices' | |
| similarities in principles of operation, technology, materials and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
4