(85 days)
The SMPle™ Pediatric Submuscular Plating System is intended for adult or pediatric patients as indicated for long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, malunions, non-union or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, and radius.
In pediatric femoral applications, the SMPle™ Pediatric Submuscular Plating System is intended for use in the treatment of femoral fractures, malunions or non-unions, femoral osteotomies required for the correction of deformity, and arthrodesis. Indications for buttressing multi-fragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
Single/multiple metallic bone fixation appliances and accessories (21 CFR 888.3030)
The provided text is a 510(k) Summary for the Biomet Trauma SMPLe™ Pediatric Submuscular Plating System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, the following information is not available in the provided text:
- A table of acceptance criteria and reported device performance.
- Details about a specific study, including sample sizes, data provenance, number or qualifications of experts, ground truth establishment, or adjudication methods for any test or training sets.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Explanation Based on the Provided Text:
The 510(k) Summary states the following as its primary method for regulatory approval:
- Substantial Equivalence: "The SMPle™ Pediatric Submuscular Plating System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and does not present any new issues of safety or effectiveness."
Instead of presenting performance data against defined acceptance criteria, the submission relies on demonstrating that the new device is as safe and effective as pre-existing, legally marketed devices (predicates). The "study" referenced here is likely a combination of engineering analysis and comparison to predicate device characteristics, which doesn't typically involve a clinical trial with specific performance metrics as would be seen for AI/diagnostic devices.
Predicates mentioned are:
- Synthes 3.5 and 4.5 Locking Compression Plates for expanded indications (K082807)
- Orthopediatrics PediLoc™ Plating Systems (K083286)
- Biomet IQL Plating System (K020221)
- Biomet OptiLock® Periarticular Plating System (K061098)
In summary, this document is a regulatory submission for a medical device (bone plating system) using the 510(k) pathway, which primarily seeks to establish substantial equivalence to predicate devices, not to present a clinical study with detailed performance acceptance criteria and results as might be expected for software-as-a-medical-device or diagnostic tools.
§ 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.