(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.
§ 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.