(30 days)
Not Found
No
The summary describes a mechanical plating system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The Gridlock Plating System is used for trauma and reconstructive procedures of small bones, which involves mechanical support rather than a therapeutic effect like healing or altering bodily functions.
No
The provided text describes the Gridlock Plating System as being intended for use in trauma and reconstructive procedures, focusing on physical implantation and stabilization. It does not mention any function related to diagnosing conditions or diseases.
No
The device description explicitly mentions plates, screws, olive wires, and guide wires, which are physical hardware components used in surgical procedures.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Gridlock Plating System clearly state it is a system of plates, screws, and instruments used for surgical procedures on bones (trauma and reconstructive). It is implanted into the body or used to facilitate the placement of implants.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
Therefore, based on the provided information, the Gridlock Plating System is a surgical device, not an In Vitro Diagnostic.
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 (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 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 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, 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)
Engineering analysis was performed. 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
510(k) Summary for the Gridlock Plating System
MAY 0 8 2013
:"
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
1. GENERAL INFORMATION
Date Prepared: April 3, 2013 Trade Name: Gridlock 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 Legally Marketed · Gridlock Plating System (K121452, K123525) Predicate Device: OsteoMed Foot Plating System (K091614) Submitter: 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
2. DEVICE DESCRIPTION
Gridlock 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 the necessary instruments to facilitate the placement of these implants.
e-mail: jdwebb@orthomedix.net
Change from Predicate:
This Special 510(k) is submitted in order to gain clearance for additional plates and screws in the Gridlock Plating System.
Materials:
CP Titanium per ASTM F67 Titanium alloy per ASTM F136
3. INTENDED 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.
1
The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS / SUBSTANTIAL EQUIVALENCE 4.
The Gridlock Plating System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances. Two bone plates have been added to the Gridlock Plating System. These two plates are for use in treating the first metatarsal phalangeal joint and are manufactured from the same material, use the same screws and instruments, and are packaged and sterilized the using the same methods as the predicate Gridlock plates.
5. NON-CLINICAL TEST SUMMARY
Engineering analysis was performed.
6. CLINICAL TEST SUMMARY
No clinical studies were performed
7. CONCLUSIONS NONCLINICAL AND CLINICAL
Trilliant Surgical LTD considers the current Gridiock Plating System to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized graphic of an abstract human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2013
Trilliant Surgical LTD % The OrthoMedix Group, Incorporated Mr. J.D. Webb Authorized Correspondent 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K130964
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: April 3, 2013 Received: April 8, 2013
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
3
Page 2 - Mr. J.D. Webb
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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/Industrv/default.htm.
Sincerely yours,
Image /page/3/Picture/8 description: The image shows the name "Erin Dkeith" in a stylized font. The letters "Erin" are in a bold, sans-serif font, while the letters "Dkeith" are in a more decorative font with geometric patterns. The name appears to be a logo or branding element.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K130964 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 (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
Prescription Use _X (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)
Elizabeth Le Frank -S
Division of Orthopedic Devices