(231 days)
The I.T.S. LRS Locking Reconstruction System is a titanium implant fracture fixation system for stabilizing fractures in long bones of the distal femur and proximal lateral tibia of all pediatric patients (less than or equal to 21 years old) or adult patient.
Indications for Use include distal/proximal shaft fractures, supracondylar fractures, intra-articular fractures, metaphyseal fractures, osteotomies, nonunions and malunions of the distal femur and proximal tibia.
The system is not intended for spinal use.
The I.T.S. LRS (Locking Reconstruction System) consisting of the DFL (Distal Femur Locking) & PTL (Proximal Lateral Tibia Locking) are fracture fixation plating systems for repairing long bone factures located in the distal femur and proximal tibia in the human body. The DFL Plates consist of three plate lengths of 5, 9, & 13 hole pre-contoured shape in a left/right configuration to fit the distal femur and the PTL Plates consist of three plate lengths of 7, 12, & 17 hole precontoured shape in a left/right configuration to fit the proximal lateral tibia. Both plate systems are manufactured from Commercialy Pure (CP) Titanium material to allow for minor intra-operative forming/contouring by the surgeon. The plate design concept offers an extramedullary, internal fixation system, minimal bone contact, and a locked fixed-angle construct using angular stability locking screws into the plate. Both locking and non-locking high strength 6-4 Alloyed Titanium screws in a 5.9mm cancellous and 4.5mm cancellous/cortical sizes are offered. All screws are self-tapping for insertion into bone. The design intent of the aiming guide instrumentation allows the surgeon to prepare percutaneous targeting of screws through 'minimal invasive' stab incisions. This aiming guide instrument ensures that all targeted screws will be properly inserted and locked to the plate. The aiming guide instrumentation is radiolucent to allow offset (90 degree) fluroscopy evaluation in bone fragment reduction of the fracture site and confirmation of screw engagement into the plate. Small holes in the plate allow intermediate 'k-wire bone fracture segment positioning' for reducing and aligning the fracture bone segments while positioning the plate and the introduction of multiple sizes of locking/nonlocking screws as needed for stabilizing the fracture - when using x-ray fluroscopy.
All I.T.S. LRS - DFL & PTL plates and screws are processed with a TIODIZE II surface treatment. A full compliment of instrumentation is available for use with the system.
The provided text describes a 510(k) Summary for the I.T.S. LRS Locking Reconstruction System, a medical device for fracture fixation. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- Device Description: Details of the DFL and PTL plating systems, materials, screw types, and instrumentation.
- Intended Use: Specifies the types of fractures and patient populations (pediatric and adult) for which the system is designed.
- Equivalence: States that the device is substantially equivalent to several predicate devices.
- Summary of Safety and Effectiveness: A general statement about its safety and effectiveness.
- Regulatory Information: FDA review and determination of substantial equivalence.
Therefore, I cannot provide the requested information from the given text.
To address your request, the input document would need to include sections detailing:
- Specific performance metrics the device is designed to achieve (acceptance criteria).
- A description of a study (e.g., mechanical testing, clinical trial) that evaluates these metrics.
- Data from that study comparing observed performance to the acceptance criteria.
- Information on study design, sample sizes, ground truth establishment, expert involvement, and statistical analyses (like MRMC studies or standalone performance).
§ 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.