(96 days)
Not Found
No
The 510(k) summary describes a mechanical plating system and does not mention any AI or ML components or functionalities.
No
The device is described as a plating system intended for trauma and reconstructive procedures of small bones, which is a structural implant for repair, not a device for treating a disease or condition in a therapeutic manner such as drug delivery or energy application.
No
The device is a plating system used for trauma and reconstructive procedures, which are therapeutic interventions rather than diagnostic ones. Its purpose is to stabilize bones, not to diagnose a condition.
No
The device description clearly states it consists of physical plates and screws made of titanium, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Gridlock Plating System is described as a system of plates and screws intended for surgical procedures to fix bones. This is an implantable surgical device, not a device used for testing biological samples.
- Intended Use: The intended use clearly states "trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device." This is a surgical application, not a diagnostic test.
The information provided describes a surgical implant system, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.
The plates and screws are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Gridlock Plating System consists of various shape and size plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited bone contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters.
Materials:
CP Titanium per ASTM F67 Titanium alloy per ASTM F136
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones in the hand/foot, ankle, 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)
Plates
- Static four point bending per ASTM F382 (Annex A1) .
- . Dynamic bending per ASTM F382 (Annex A2)
Screws
- Static Axial Pull-out per ASTM F543 .
- Driving Torque per ASTM F543 .
- Torque to Failure per ASTM F543 .
The results of this testing indicate that the Gridlock Plating System is equivalent to predicate devices.
CLINICAL TEST SUMMARY
No clinical studies were performed
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.
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
K1214.52
p.1/2
510(k) Summa for the Gridlock Plating System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Gridlock Plating System
AUG 20 2012
GENERAL INFORMATION 1.
Date Prepared: May 11, 2012
Trade Name: Gridlock Plating System
Common Name: bone plate
Classification Name: Single/multiple component metallic bone fixation appliances and accessories
Class: II
Product Code: HRS / HWC
CFR section: 21 CFR section 888.3030 / 888.3040
Device panel: Orthopedic
Legally Marketed
Predicate Device: OsteoMed Foot Plating System - K091614
Submitter: Trilliant Surgical LTD 602 Sawyer Street, Suite 120
Houston, TX 77007
Contact: J.D. Webb
1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199 Tele 512-692-3699 Fax e-mail: jdwebb@orthomedix.net
2. DEVICE DESCRIPTION
The Gridlock Plating System consists of various shape and size plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited bone contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters.
Materials:
CP Titanium per ASTM F67 Titanium alloy per ASTM F136
SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES 3.
The Gridlock Plating System is substantially equivalent to the predicate device in terms of intended use, design, materials used, mechanical safety and performances.
INTENDED USE ধं
The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, 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.
1
NON-CLINICAL TEST SUMMARY 5.
The following tests were performed:
Plates
- Static four point bending per ASTM F382 (Annex A1) .
- . Dynamic bending per ASTM F382 (Annex A2)
Screws
- Static Axial Pull-out per ASTM F543 .
- Driving Torque per ASTM F543 .
- Torque to Failure per ASTM F543 .
The results of this testing indicate that the Gridlock Plating System is equivalent to predicate devices.
CLINICAL TEST SUMMARY 6.
No clinical studies were performed
7. CONCLUSIONS NONCLINICAL AND CLINICAL
This summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that Gridlock Plating System is as safe, as effective, and performs as well as the predicate device.
2
Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black. The overall design is simple and conveys a sense of official government authority.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 0 2012
Trilliant Surgical Limited % The OrthoMedix Group, Incorporated Mr. J. D. Webb Authorized Contact Person 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K121452
Trade/Device Name: Gridlock 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: August 9, 2012 Received: August 14, 2012
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
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Page 2 - Mr. J. D. Webb
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark A. Millmann
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: ___ Gridlock Plating System_
Indications for Use:
The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.
The plates and screws are intended for single use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aush
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121452