(520 days)
The I.T.S. Pelvic Reconstruction Systems (PRS RX & PRS Phoenix) are indicated to stabilize one or more pelvic bone fractures in the pelvis in an adult patient.
Indications for use of the I.T.S. Pelvic Reconstruction System (PRS RX) include:
- Fractures of the acetabulum
- Fractures of the pelvic ring
- Fractures of the quadrilateral surface
- Fractures of the symphysis
- Fractures of the ilium
- Fractures of the SIJ
- Ilio-iliac distance osteosynthesis
- Symphysis pubis disruptions, osteotomies, arthrodesis and sacroiliac joint dislocations
- Revision surgery of pseudoarthroses, non-unions and mal-unions
The I.T.S. PRS RX System is not intended for spinal use.
Indications for use of the I.T.S. Pelvic Reconstruction System (PRS Phoenix) include:
- Fractures involving the Posterior Wall & Posterior Column
- Fractures involving the Anterior Column of the Acetabulum
- Fractures involving the Quadrilateral Surface
- Symphyseal Disruptions & Para-symphyseal Fractures
- Fractures of the ilium
- Fractures of the SIJ
- Dorsal neutralization plating for posterior pelvic ring fractures
- Osteotomies, arthrodesis and sacroiliac joint dislocations
- Revision surgery of pseudoarthroses, non-unions and mal-unions
The I.T.S. PRS Phoenix System is not intended for spinal use.
Indications for use of the I.T.S. Infra-acetabular screw placement include:
- Fractures involving the anterior column, e.g. anterior column plus posterior hemitransverse (ACPH) and associated both column (ABC) fractures
The I.T.S. Infra-acetabular screw is not intended for spinal use.
Indications for use of the I.T.S. 8.5mm Cannulated Screws & Washer include:
- Pelvic fractures
The I.T.S. 8.5mm Cannulated Screws & Washer are not intended for spinal use.
The I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) encompasses a number of fracture fixation subsystems of multiple plate designs for fracture fixation and reconstruction of pelvic ring fractures in the pelvis. The I.T.S. Pelvic Reconstruction Plating System (PRS RX & PRS Phoenix) consists of the following plate types: 1) A Curved Plate at a 2.5mm thickness with 4 to 16 hole length sizes, 2) A Straight Plate at a 2.5mm thickness with 10 to 14 hole length sizes, 3) A SIJ Closed Plate at a 2.5mm thickness in a 4-hole size, 4) A SIJ L-Plate at a 2.5mm thickness in a 5-hole size, 5) A J-Plate at a 2.5mm thickness with 6 to 16 hole length sizes, 6) A Symphysis Plate at a 4.0mm thickness in a 4 & 6 hole size, 7) A Symphysis Plate Curved at a 4.0mm thickness in a 6 & 8 hole size, 8) A RIM Plate at a 2.5mm thickness in a 10 & 14 hole, Right & Left size. 9) A Posterior Wall Plate at a 2.5mm thickness in a 6 hole, Right & Left size. 10) A Posterior Wall Plate II at a 2.5mm thickness in a 7 & 8 hole, Right & Left size, 11) A Quadrilateral Column Plate at a 2.5mm thickness in a Small & Large, Right & Left size, 12) A Quadrilateral Supporting Plate at a 2.5mm thickness in a Right & Left size. 13) A Posterior Wall Plate Extended at a 2.5mm thickness in a Small & Large, Right & Left size, 14) A Posterior Column Plate at a 2.5mm thickness in a 8-hole, Right & Left size, All plate designs are low profile in thickness and made from Implant Grade 2 CP Titanium material (to ASTM F67). The PRS RX & PRS Phoenix Plating System encompasses a 3.5mm Cortical Locking and Standard Screw and a 4.2mm Cancellous Locking Screw in various lengths. All bone screws are pre-drilling and self-tapping in design and manufactured from Implant Grade 5 high strength 6-4 Alloyed Titanium (to ASTM F136). A threaded Spike allows inter-operative plate fixation to bone fragments. The Spike is also manufactured from Implant Grade 5 high strength 6-4 Alloyed Titanium material (to ASTM F136). All components (plates, screws, spike) have a anodize 'DOTIZE' Type II surface treatment preparation. Ancillary instrumentation (Drills, Drill Guides, Insertion Guides, Clamps, Bending Heaver, Measuring Gauges, and Screwdrivers) is made available for bone fragment reduction and plate/screw placement and insertion. All plates, screws, spike are provided Non-Sterile for single-use.
This document describes a medical device submission, K210935, for the I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix). This device is a metallic bone fixation appliance used to stabilize pelvic bone fractures.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics with thresholds. Instead, the substantial equivalence decision is based on comparisons to predicate devices through performance testing and engineering analysis. The "performance" described is the successful completion of these tests in accordance with recognized standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Plate bending strength | Performance testing under ASTM F382 and FEA analysis simulation following ASTM F382 were performed. (Details of specific values or passing thresholds are not provided in this document). |
| Plate bending stiffness | Performance testing under ASTM F382 and FEA analysis simulation following ASTM F382 were performed. (Details of specific values or passing thresholds are not provided in this document). |
| Screw insertion/removal | Performance testing under ASTM F543 was performed. (Details of specific values or passing thresholds are not provided in this document). |
| Screw yield torque | Performance testing under ASTM F543 was performed. (Details of specific values or passing thresholds are not provided in this document). |
| Screw self-tapping torque | Performance testing under ASTM F543 was performed. (Details of specific values or passing thresholds are not provided in this document). |
| Screw axial pullout strength | Performance testing under ASTM F543 was performed. (Details of specific values or passing thresholds are not provided in this document). |
| Biocompatibility | Biocompatibility Risk Assessments were performed. (Specific results not detailed). |
| Material equivalence | Identical CP titanium grade 2 for all plate components (to ASTM F67) and identical titanium alloy 6Al-4V for all screw components (to ASTM F136) as the predicate device. |
| Geometry/Dimensions/Design equivalence | Comparable in plate sizes, thickness, width, and locking features to the predicate device. |
| Manufacturing equivalence | Identical manufacturing steps to the predicate device. |
| Surface treatment equivalence | Identical anodization with Type II to the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the performance tests (e.g., number of plates or screws tested). It states "Performance testing as a consensus standard was performed under ASTM F543 for all bone screws and under ASTM F382 for bone plates and in addition a FEA analysis simulation following ASTM F382."
The data provenance is from non-clinical testing (bench testing and simulations). No human clinical data was submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as there was no clinical study, and therefore no ground truth established by medical experts for a clinical test set. The evaluation relies on engineering and material science standards.
4. Adjudication method for the test set
This information is not applicable as there was no clinical study requiring adjudication of clinical outcomes or interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The submission explicitly states: "Clinical data was not submitted."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical implant (pelvic reconstruction system), not a software algorithm or AI component.
7. The type of ground truth used
This is not applicable in the context of clinical "ground truth." The "ground truth" for evaluating this device's performance is based on engineering standards and specifications (ASTM F543 for screws, ASTM F382 for plates) and the characteristics of legally marketed predicate devices.
8. The sample size for the training set
This is not applicable as the device is a physical medical implant and does not involve AI/machine learning, thus no "training set" is used.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as above.
§ 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.