(112 days)
The PRO Plating System is indicated for:
· Fractures, non-unions, deformities and malunions of the pelvic ring and acetabulum
• Sacroiliac joint dislocations
The Stryker Trauma Pelvic Set (Matta) is indicated for:
• Fractures of the acetabulum, sacrum, illium, and entire pelvic ring;
• Revision surgery of pseudarthrosis, non-unions and mal-unions;
• Osteonomies;
• Arthrodeses;
• Sacroilic joint dislocations;
• Symphysis pubis disruptions
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the PRO Plating System, to align indication of the existing PRO Pelvis System and the new devices and add MRI labeling to the existing PRO Pelvis System and the Trauma Pelvic Set System (Matta). This submission encompasses multiple systems (PRO Pelvis System and Trauma Pelvic Set System (Matta)) that have similar intended use and/or will be used together during the surgical procedure.
The PRO Plating System (Pelvis II Implant System) is an internal fixation device that consists of different types of plates used with compatible screws to fit different types of fractures in the pelvis. All devices in the system are provided sterile and non-sterile.
The Stryker Trauma Pelvic Set System (Matta) consists of plate, screw, and washer components of various sizes. All are manufactured from stainless steel (ASTM F-138/139). All devices in the system are provided sterile and non-sterile.
This document describes a 510(k) premarket notification for the Stryker PRO Plating System and Stryker Trauma Pelvic Set (Matta). This submission is for a medical device (bone fixation appliances and accessories), not for an AI/ML powered device. As such, the sections regarding AI/ML performance criteria, ground truth, expert adjudication, and comparative effectiveness studies are not applicable.
Here's a summary of the non-clinical performance data provided, as relevant to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Single Cycle Bend (per ASTM F382) | Demonstrated resistance to bending under single load. (Implicitly, to meet or exceed predicate device performance) | Performed: Testing conducted as per ASTM F382. (Specific numerical results are not provided in this summary but were presumably submitted to the FDA.) |
| Bending Fatigue (per ASTM F382) | Demonstrated durability under repeated bending loads. (Implicitly, to meet or exceed predicate device performance) | Performed: Testing conducted as per ASTM F382. (Specific numerical results are not provided in this summary but were presumably submitted to the FDA.) |
| MRI Compatibility: Magnetic Induced Displacement (per ASTM F2052) | Acceptable magnetic attraction in an MRI environment. | Performed: Testing conducted as per ASTM F2052. (Specific results not provided but deemed acceptable for clearance.) |
| MRI Compatibility: Magnetic Induced Torque (per ASTM F2213) | Acceptable torque in an MRI environment. | Performed: Testing conducted as per ASTM F2213. (Specific results not provided but deemed acceptable for clearance.) |
| MRI Compatibility: RF Heating (per ASTM F2182) | Acceptable temperature rise in an MRI environment. | Performed: Testing conducted as per ASTM F2182. (Specific results not provided but deemed acceptable for clearance.) |
| MRI Compatibility: Image Artifacts (per ASTM F2119) | Acceptable level of image distortion in an MRI environment. | Performed: Testing conducted as per ASTM F2119. (Specific results not provided but deemed acceptable for clearance.) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify the exact sample sizes used for each non-clinical test. For mechanical and MRI compatibility testing of medical devices, samples are typically chosen to represent the range of device types, sizes, and materials. The data provenance is implied to be from internal laboratory testing conducted by Stryker or a qualified testing facility, relevant to the manufacturing location (Selzach, Switzerland) and for the US market. The data is non-clinical/pre-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is not an AI/ML device that requires expert-established ground truth for its performance assessment. The "ground truth" for this type of device is established through engineering and material science principles, and adherence to recognized standards like ASTM.
4. Adjudication Method for the Test Set
Not applicable. This device is not an AI/ML device requiring human adjudication of its output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done as this is not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical implant, not an algorithm, so standalone performance in the context of AI/ML is irrelevant.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on established engineering principles, material science, and conformance to recognized consensus standards (e.g., ASTM F382, F2052, F2213, F2182, F2119). These standards define the methodologies and acceptable performance metrics for the tested properties.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of medical device.
{0}------------------------------------------------
April 7, 2023
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 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.
Stryker GMbH Danielle Madureira Associate Manager Regulatory Affairs 325 Corporate Drive Mahwah. New Jersev 07430
Re: K223772
Trade/Device Name: PRO Plating System, Stryker Trauma Pelvic Set (Matta) 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 Dated: December 16, 2022 Received: December 16, 2022
Dear Danielle Madureira:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
{1}------------------------------------------------
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 (QS) 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 medical devices and radiation-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 -S
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) K223772
Device Name PRO Plating System
Indications for Use (Describe)
The PRO Plating System is indicated for:
· Fractures, non-unions, deformities and malunions of the pelvic ring and acetabulum
· Sacroiliac joint dislocations
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K223772
Device Name Stryker Trauma Pelvic Set (Matta)
Indications for Use (Describe)
The Stryker Trauma Pelvic Set (Matta) is indicated for:
- · Fractures of the acetabulum, sacrum, illium, and entire pelvic ring;
- · Revision surgery of pseudarthrosis, non-unions and mal-unions;
- · Osteonomies:
- · Arthrodeses;
- · Sacroilic joint dislocations;
- Symphysis pubis disruptions
| 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.
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
| Proprietary Name: | PRO Plating SystemTrauma Pelvic Set System (Matta) |
|---|---|
| Common Name: | Plate, Fixation, Bone and Screw, Fixation, Bone |
| Regulation Description: | 21 CFR 888.3030: Single/Multiple component metallic bone fixationappliances and accessories21 CFR 888.3040: Smooth or threaded metallic bone fastener |
| Regulation Number: | 21 CFR 888.3040 (primary), 21 CFR 888.3030 |
| Classification Product Code: | HRS, HWC |
| Device Class: | II |
| Sponsor: | Stryker GMBHBohnackerweg 12545 Selzach, Switzerland |
| Contact Person: | Danielle Jannuzzi Madureira, PhDAssociate Manager Regulatory AffairsDr. Homer Stryker Strasse, 1CH-2545 Selzach, SwitzerlandPhone: +41 79 890 02 89Fax: +41 32 641 66 60 |
| Date: | December 05, 2022 |
| Primary Predicate: | PRO Plating System K131132 |
| Additional Predicate: | Trauma Pelvic Set System (Matta) K001614 |
| Reference Device: | aap Bone Plates and Screw Implants K072411 |
| Device Description: | This Traditional 510(k) submission is being supplied to the U.S. FDA togain clearance to market the new devices of the PRO Plating System, toalign indication of the existing PRO Pelvis System and the new devices andadd MRI labeling to the existing PRO Pelvis System and the Trauma PelvicSet System (Matta). This submission encompasses multiple systems (PROPelvis System and Trauma Pelvic Set System (Matta)) that have similarintended use and/or will be used together during the surgical procedure.The PRO Plating System (Pelvis II Implant System) is an internal fixationdevice that consists of different types of plates used with compatible screwsto fit different types of fractures in the pelvis. All devices in the system areprovided sterile and non-sterile.The Stryker Trauma Pelvic Set System (Matta) consists of plate, screw, andwasher components of various sizes. All are manufactured from stainlesssteel (ASTM F-138/139). All devices in the system are provided sterile andnon-sterile. |
| Indications for Use: | The PRO Plating System is indicated for:Fractures, non-unions, deformities and malunions of the pelvic ring● |
| and acetabulum• Sacroiliac joint dislocationsThe Stryker Trauma Pelvic Set (Matta) is indicated for:• Fractures of the acetabulum, sacrum, illium, and entire pelvic ring;• Revision surgery of pseudarthrosis, non-unions and mal-unions;• Osteonomies;• Arthrodeses;• Sacroilic joint dislocations;• Symphysis pubis disruptions | |
| Comparison to PredicateDevice: | A comparison of the system demonstrated that the subject PRO PlatingSystem is substantially equivalent to the PRO Plating System, StrykerTrauma Pelvic Set (Matta) and aap Bone Plates regarding intended use,material, design, and operational principles.A comparison of the system demonstrated that the subject Stryker TraumaPelvic Set (Matta) is substantially equivalent to the Stryker Trauma PelvicSet (Matta) regarding intended use, material, design, and operationalprinciples. |
| Performance Data (Nonclinical): | Non-Clinical Performance and Conclusions:The following non-clinical laboratory testing, and performance assessmentswere made in support of substantial equivalence:• Single Cycle Bend and Bending Fatigue Testing per ASTM F382Tests performed to establish compatibility with a magnetic resonanceenvironment:• Magnetically Induced Displacement per ASTM F2052• Magnetically Induced Torque per ASTM F2213• RF Heating per ASTM F2182• Image Artifacts per ASTM F 2119Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device. |
| Conclusion: | Except for the modifications described in this submission the subjectdevices are identical to the predicate device, and the performance data andanalyses demonstrate that any differences do not raise new questions ofsafety and effectiveness as established with performance testing andtherefore, the subject devices PRO Plating System and Stryker TraumaPelvic Set (Matta) is substantially equivalent to the previously clearedpredicate device PRO Plating System and Stryker Trauma Pelvic Set(Matta) |
{5}------------------------------------------------
§ 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.