(65 days)
The intended use of the I.T.S. Pelvic Reconstruction System (PRS) is to stabilize one or more pelvic bone fractures in the 'pelvic ring' area of the pelvis of an adult or pediatric patient which include the use of the following pelvic fracture fixation systems.
Indications for use of the I.T.S. PRS Low Profile - Multiple Type - Pelvic Plating System include:
- Fracture reconstruction of the acetabulum, sacrum, illium, and entire pelvic ring,
- Revision surgery of pseoduarthroses, non-unions and mal-unions,
- Ilio-Iliac distance osteosynthesis,
- Osteotomies,
- Arthrodesis,
- Sacroiliac joint dislocations, and
- Symphysis pubis disruptures
Indications for use of the I.T.S. PRS Sacral Rod System include:
- Fixation of fractures of the posterior pelvis,
- Fixation of fractures of the posterior iliac spine,
- Fixation of fractures of the posterior inferior illac spine,
- Dorsal stabilization of the posterior pelvic ring for unstable pelvic ring injuries,
- Fixation of sacral fractures, and
- Fracture dislocations of the sacro-iliac joint
Indications for use of the I.T.S. PRS 7.3mm Cannulated SIJ Traction Screw & Washer include fracture fixation of pelvic bone fractures where indicated and for periacetabular osteotomies.
The system(s) has not been studied in spinal use, and is not intended for use in vertebral column fracture or fusion procedures.
The I.T.S. Pelvic Reconstruction System (PRS) encompasses a number of fracture fixation subsystems (multiple pelvic plate designs, sacral threaded rod, and cannulated screw & washer) for facture fixation and reconstruction of pelvic ring fractures in the pelvis.
The I.T.S. PRS Low Profile - Multiple Type - Pelvic Plating System consists of the following plate types: 1) A Straight Plate at a 2.5mm thickness with 10 to 14 hole length sizes, 2) A Curved Plate with a 108mm radius at a 2.5mm thickness with 4 to 16 hole length sizes, 3) A Curved Plate with a 88mm radius at a 2.5mm thickness also with 4 to 16 hole length sizes, 4) A Symphysis Plate at a 4.0mm thickness in both a 4 & 6 hole size, 5) A SacroIlliac-Joint (SIJ) L-Shaped Plate at a 2.5mm thickness in a left and right 5 hole size, and 6) A SIJ Closed Plate at a 2.5mm thickness in a 4 hole size.
All plate designs are low profile in thickness and made from CP of Cancellous (5.9mm std.compression & 5.9mm Locking screws) and Cortical (4.5mm std.compression screw) screw types and length sizes. All bone screws are pre-drilling and self-tapping in design and manufactured from high strength 6-4 Alloyed Titanium. All components (plates & screws) have a TIODIZE II surface treatment preparation. The I.T.S. PRS Sacral Rod System consists of a threaded pin, wedgeshaped washers, and nut/locknut design with one end of the threaded pin having a trocar point. The assembled unit is used to stabilize ilio-iliac posterior pelvic ring disruption injuries. All components are manufactured from high strength 6-4 Alloyed Titanium material and have the TIODIZE II surface preparation. The I.T.S. PRS 7.3mm Cannulated SIJ Traction Screw & Washer is a pre-drilling, self-tapping, and back-tapping screw design for guided reduction of pelvic bone fractures. Washers (flat & curved) are available for use with the screw. All 7.3mm Cannulated Screws & washers are manufactured from high strength 6-4 Alloyed Titanium and have the TIODIZE II surface preparation.
This document is a 510(k) summary for a medical device called the Pelvic Reconstruction System (PRS). It does not contain information about studies proving the device meets acceptance criteria for a medical device that analyzes data or images. This is a submission for a physical implantable device.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as these elements are not relevant to the type of device and submission described in the provided text.
The document primarily focuses on:
- Device Description: What the Pelvic Reconstruction System is and its components (plates, screws, sacral rod).
- Intended Use/Indications for Use: The medical conditions and procedures for which the device is designed to be used (e.g., stabilizing pelvic bone fractures, revision surgery, osteotomies).
- Substantial Equivalence: A comparison to existing, legally marketed devices to demonstrate that the new device is as safe and effective. This is the primary basis for clearance for this type of device.
No information regarding algorithm performance, reader studies, AI assistance, or data-driven acceptance criteria is present.
§ 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.