(520 days)
Not Found
No
The device description focuses solely on the physical components (plates, screws, spike) and materials used for fracture fixation. There is no mention of software, algorithms, image processing, or any other elements that would suggest the incorporation of AI or ML.
Yes.
The device is used to stabilize pelvic bone fractures for reconstruction, which is a therapeutic intervention.
No
Explanation: The device description indicates that the I.T.S. Pelvic Reconstruction Systems are comprised of plates, screws, and ancillary instrumentation for the surgical stabilization and reconstruction of pelvic bone fractures. This describes a therapeutic, rather than a diagnostic, function.
No
The device description explicitly details various physical components such as plates, screws, and ancillary instrumentation made from titanium, indicating it is a hardware-based medical device for fracture fixation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stabilize one or more pelvic bone fractures in the pelvis in an adult patient." This is a surgical intervention to treat a physical condition.
- Device Description: The device consists of plates, screws, and instrumentation designed for bone fixation and reconstruction. These are physical implants and tools used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the I.T.S. Pelvic Reconstruction Systems does not involve any testing of biological samples.
The device is clearly a surgical implant system for orthopedic use.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTN
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 singleuse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis
Indicated Patient Age Range
adult patient
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. An Engineering Analysis and Perfomance Testing was provided for plate bending strength and bending stiffness and screw insertion/removal, yield torque, self-tapping torque and axial pullout strength to demonstrate substantial equivalence. Biocompatibility Risk Assessments were also performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K063166, K131722, K001614, K131132, K031573, K093928, K122538, K061973
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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. GmbH
Autal 28
Lassnitzhoehe, 8301
Austria
www.its-implant.com |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Jennifer Hadfield
Qserve Group US, Inc.
350 S Main Street, Suite 309
Doylestown, Pennsylvania, 18901, United States
Tel. No. 215-6003103
e-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 and
accessories (primary)
Class II, (see 21 CFR. Sec. 888.3030)
Smooth or threaded metallic bone fixation fastener
Class 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,
5
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.
6
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.
7
| BASIS OF SUBSTANTIAL
EQIVLAENCE: | The I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) is
Substantially Equivalent (SE) to the I.T.S, Stryker, Synthes, and Acumed
- Pelvic Reconstruction - Predicate Systems. An Engineering Analysis
and Perfomance Testing was provided for plate bending strength and
bending stiffness and screw insertion/removal, yield torque, self-tapping
torque 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 under
ASTM F543 for all bone screws and under ASTM F382 for bone plates
and in addition a FEA analysis simulation following ASTM F382. |
| SUMMARY OF TECHNO-
LOGICAL
CHARACTERISTICS: | The I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) is
substantially equivalent in material, geometry, design, indications
and operational principles to the following predicate systems legally
marketed 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 and
identical titanium alloy 6Al-4V for all screw components - Chemical composition: identical CP titanium grade 2 acc. to ASTM F67
and 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 and
operational principles, as well as both the Engineering Analysis and
Performance Testing, the I.T.S. Pelvic Reconstruction System (PRS RX
& PRS Phoenix) has been demonstrated to be substantially equivalent
(SE) to the predicate devices. |