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.

Device Description

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.

AI/ML Overview

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.

Summary

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August 31, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

I.T.S. GmbH c/o Jennifer Hadfield Oserve Group US U.S. Agent and Official Correspondent 350 S Main Street, Suite 309 Doylestown, PA 18901

Re: K210935

Trade/Device Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC, HTN Dated: March 15, 2021 Received: March 29, 2021

Dear Jennifer Hadfield:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210935

Device Name

I.T.S. Pelvic Reconstruction Systems (PRS RX & PRS Phoenix)

Indications for Use (Describe)

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 sympyhsis
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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary of Safety and Effectiveness

In Accordance with 21 CFR 807.92 of the Federal Code of Regulations 510(k) Summary

NAME OF FIRM:	I.T.S. GmbHAutal 28Lassnitzhoehe, 8301Austriawww.its-implant.com
510(k) FIRM CONTACT:	Jennifer HadfieldQserve Group US, Inc.350 S Main Street, Suite 309Doylestown, Pennsylvania, 18901, United StatesTel. No. 215-6003103e-mail: jennifer.hadfield@qservegroup.com
TRADE NAME:	I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
DATE:	August 30th, 2022
COMMON NAME:	Plate, Fixation, Bone; Screw, Fixation, Bone; Washer, Bolt Nut
CLASSIFICATION:	Single/multiple component metallic bone fixation appliances andaccessories (primary)Class II, (see 21 CFR. Sec. 888.3030)Smooth or threaded metallic bone fixation fastenerClass II, (see 21 CFR. Sec. 888.3040)

DEVICE PRODUCT CODE: HRS, HWC, HTN

SUBSTANTIAL EQUIVALENCE: PRIMARY PREDICATE I.T.S. - Pelvic Reconstruction System - PRS (K063166) ADDITIONAL PREDICATES I.T.S. - FLS Extremity System (K131722) Stryker - Trauma Pelvic Set (K001614) Stryker - Pelvis II Implant System (K131132) Synthes - 3.5mm Low Profile Pelvic Reconstruction Plate (K031573) Synthes - 3.5mm Quadrilateral Surface Plates (K093928) Acumed - Pelvic Bone Plate System (K122538) Synthes - 3.5mm Spring Plate (K061973) DEVICE DESCRIPTION: 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,

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I.T.S. GmbH - Pelvic Reconstruction System (PRS RX & PRS Phoenix) - 510(k) Summary

A Symphysis Plate at a 4.0mm thickness in a 4 & 6 hole size,
A Symphysis Plate Curved at a 4.0mm thickness in a 6 & 8 hole size,
A RIM Plate at a 2.5mm thickness in a 10 & 14 hole, Right & Left size.
A Posterior Wall Plate at a 2.5mm thickness in a 6 hole, Right & Left size.
A Posterior Wall Plate II at a 2.5mm thickness in a 7 & 8 hole, Right & Left size,
A Quadrilateral Column Plate at a 2.5mm thickness in a Small & Large, Right & Left size,
A Quadrilateral Supporting Plate at a 2.5mm thickness in a Right & Left size.
A Posterior Wall Plate Extended at a 2.5mm thickness in a Small & Large, Right & Left size,
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 singleuse.

INTENDED USE:

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 disruptures, osteotomies, arthrodesis and sacroiliac joint dislocations,

· Revision surgery of pseudoarthrosis, non-unions and mal-unions

The I.T.S. Pelvic Reconstruction System (PRS RX) is not intended for spinal use.

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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. Pelvic Reconstruction System (PRS Phoenix) 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, anterior column plus posterior hemitransverse (ACPH) and associated both column (ABC) fractures

The I.T.S. Infra-acetabular screw placement 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.

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BASIS OF SUBSTANTIALEQIVLAENCE:	The I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) isSubstantially Equivalent (SE) to the I.T.S, Stryker, Synthes, and Acumed- Pelvic Reconstruction - Predicate Systems. An Engineering Analysisand Perfomance Testing was provided for plate bending strength andbending stiffness and screw insertion/removal, yield torque, self-tappingtorque and axial pullout strength to demonstrate substantial equivalence.Biocompatibility Risk Assessments were also performed.
CLINICAL TESTING:	Clinical data was not submitted.
NON-CLINICAL TESTING:	Performance testing as a consensus standard was performed underASTM F543 for all bone screws and under ASTM F382 for bone platesand in addition a FEA analysis simulation following ASTM F382.
SUMMARY OF TECHNO-LOGICALCHARACTERISTICS:	The I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) issubstantially equivalent in material, geometry, design, indicationsand operational principles to the following predicate systems legallymarketed in the US:
PRIMARY PREDICATE	I.T.S. - Pelvic Reconstruction System - PRS (K063166)Differences in technological characteristics:- Geometry / Dimensions / Design: comparable in plate sizes, thickness,width and locking features- Material: identical CP titanium grade 2 for all plate components andidentical titanium alloy 6Al-4V for all screw components- Chemical composition: identical CP titanium grade 2 acc. to ASTM F67and identical titanium alloy 6Al-4V acc. to ASTM F136- Manufacturing: identical manufacturing steps- Surface treatment: identical anodization with Type II
CONCLUSIONS:	Based on the similarity in material, geometry, design, indications andoperational principles, as well as both the Engineering Analysis andPerformance Testing, the I.T.S. Pelvic Reconstruction System (PRS RX& PRS Phoenix) has been demonstrated to be substantially equivalent(SE) to the predicate devices.

Regulation Number and Section

§ 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.