(30 days)
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.
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.
The provided text describes a 510(k) submission for the Gridlock Plating System, a medical device for orthopedic trauma and reconstructive procedures. Based on the document, here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to predicate devices rather than meeting specific performance criteria against a predefined standard. The acceptance criteria essentially revolve around demonstrating that the new components (additional plates and screws) within the Gridlock Plating System do not alter the fundamental safety and effectiveness profile such that new clinical testing would be required.
| Acceptance Criteria Category | Reported Device Performance (as described) |
|---|---|
| Intended Use | The Gridlock Plating System (including the new plates) is intended for trauma and reconstructive procedures of small bones in the hand/foot, ankle, and other bones appropriate for the device size. This matches the predicate devices. |
| Design | The new plates are for the first metatarsal phalangeal joint. The system maintains features like low profile, limited contact, dynamic/manual compression capability, and angulated-locking threaded screw holes. This is considered substantially equivalent to the predicate devices. |
| Materials Used | CP Titanium per ASTM F67 and Titanium alloy per ASTM F136. This is stated to be the same as the predicate Gridlock plates. |
| Mechanical Safety & Performance | Verified through engineering analysis. No specific performance metrics (e.g., fatigue strength, pull-out force) or thresholds are provided in this summary, but the general statement implies equivalence to predicate mechanical properties. |
| Manufacturing, Packaging, and Sterilization Methods | The manufacturing, packaging, and sterilization methods for the new plates are the same as the predicate Gridlock plates. |
| Risk Profile | Not explicitly stated as a separate criterion, but implied to be equivalent to the predicate devices due to similarities in design, materials, and intended use. |
Study Details
The provided document largely lacks information on clinical studies or detailed performance trials in the way one might expect for a novel device or one requiring extensive performance validation against acceptance criteria with empirical data.
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Sample size used for the test set and the data provenance:
- No clinical test set was used. The document explicitly states: "No clinical studies were performed."
- Data provenance: Not applicable.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set or ground truth establishment by experts was performed for this 510(k) submission. The assessment relies on engineering analysis and comparison to predicate device characteristics.
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Adjudication method for the test set:
- Not applicable. No clinical test set or adjudication process was performed.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No such study was performed. This device is a metallic bone plating system, not an AI-assisted diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not a software algorithm.
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The type of ground truth used:
- Engineering Analysis and Substantial Equivalence to Predicate Devices: The "ground truth" for this submission is based on the established safety and effectiveness of the legally marketed predicate devices (OsteoMed Foot Plating System K091614, and previous versions of Gridlock Plating System K121452, K123525). The new components are asserted to be similar enough to fall under the same safety and effectiveness profile.
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The sample size for the training set:
- Not applicable. No training set for an algorithm was used.
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How the ground truth for the training set was established:
- Not applicable. No training set was used.
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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.
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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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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
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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
§ 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.