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The JPS JuniOrtho Plating System™ is internal fixation and stabilization of fractures, osteotomies, mal-unions and non-unions of long bones of the lower limb.

The JPS JuniOrtho Plating System™ is indicated for internal fixation of femoral and tibial fractures, osteotomies, mal-unions and non-unions.

Indications include:

• Varus, valgus, rotational and/or shortening osteotomies
• Femoral neck and/or pertrochanteric fractures
• Proximal and distal metaphyseal fractures
• Pathological and impeding pathological fractures

Use of the JPS JuniOrtho Plating System™ is indicated in pediatric (excluding newborns) and small stature adult patients.

The JPS JuniOrtho Plating System™ consists of plate's sizes and shapes ranges, designed to accept locking and cortical bone screws, which are available in a variety of diameters and lengths, in order to support internal fixation and stabilization of fractures, osteotomies, mal-unions and non-unions in long bones of lower limbs. The JPS JuniOrtho Plating System™ is designed according to the anatomic region of clinical application: femur and tibia. The implants would be offered both in sterile and non-sterile packaging configurations.

The subject device implants, bone plates and bone screws, are made from Stainless steel AISI 316LVM, according to ASTM F138 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".

Surgical procedures with the use of the subject implants may be performed with the support of general orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The instruments and accessories offered by Orthofix are classified as class I devices exempt from 510(k), under the product code LXH, according to 21 CFR 888.4540 Orthopedic Manual Surgical Instrument, and product code FSM according to 21 CFR 878.4800 Manual surgical instrument for general use.

These instruments are made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 420B, AISI 303, X15TN), Aluminum alloy (EN-AW 6082 T6), and plastic material (PP-H PROPILUX).

JPS JuniOrtho Plating System™ is designed to be used in the operating theatre only.

This is a medical device 510(k) summary, not a study report for an AI/ML powered device. As such, it does not contain any information about:

• Acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes or data provenance for a test set.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

This document describes a traditional medical device, the "JPS JuniOrtho Plating System™," which consists of physical plates and screws for internal fixation of bones. The performance analysis mentioned refers to bench testing and engineering assessments of the mechanical properties of the hardware, compared to predicate devices, to demonstrate substantial equivalence.

Therefore, I cannot provide the requested table and information based on the provided text.

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