Who is the manufacturer of PRO Plating System, Stryker Trauma Pelvic Set (Matta)?

Stryker GmbH filed the 510(k) submission for PRO Plating System, Stryker Trauma Pelvic Set (Matta) (K223772).

What is the FDA product code for PRO Plating System, Stryker Trauma Pelvic Set (Matta)?

HRS. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for PRO Plating System, Stryker Trauma Pelvic Set (Matta)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PRO Plating System, Stryker Trauma Pelvic Set (Matta)?

PRO Plating System (K131132); Trauma Pelvic Set System (Matta) (K001614).

Who can help prepare an FDA 510(k) submission like PRO Plating System, Stryker Trauma Pelvic Set (Matta)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PRO Plating System, Stryker Trauma Pelvic Set (Matta)

K223772 · Stryker GmbH · HRS · Apr 7, 2023 · Orthopedic

Device Facts

Record ID	K223772
Device Name	PRO Plating System, Stryker Trauma Pelvic Set (Matta)
Applicant	Stryker GmbH
Product Code	HRS · Orthopedic
Decision Date	Apr 7, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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

Device Story

Internal bone fixation system comprising plates, screws, and washers; used for pelvic and acetabular fracture stabilization. Devices implanted by surgeons in clinical/OR settings. System provides mechanical support to bone segments to facilitate healing. Subject of 510(k) for alignment of indications and addition of MRI labeling. No software or algorithmic components.

Clinical Evidence

No clinical data. Bench testing only, including single cycle bend and bending fatigue testing (ASTM F382) and MRI compatibility testing (ASTM F2052, F2213, F2182, F2119).

Technological Characteristics

Metallic bone fixation plates, screws, and washers. Materials: Stainless steel (ASTM F-138/139). Provided sterile and non-sterile. Mechanical fixation principle. No software, electronics, or energy sources.

Indications for Use

Indicated for patients requiring internal fixation for pelvic ring and acetabular fractures, non-unions, mal-unions, deformities, sacroiliac joint dislocations, symphysis pubis disruptions, osteotomies, and arthrodeses.

Regulatory Classification

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.

Predicate Devices

PRO Plating System (K131132)
Trauma Pelvic Set System (Matta) (K001614)

Reference Devices

aap Bone Plates and Screw Implants (K072411)

Related Devices

K131132 — PELVIS II IMPLANT SYSTEM · Stryker Trauma AG · May 31, 2013
K171808 — TDM Plate and Screw System · Tdm Co., Ltd. · Mar 15, 2018
K250055 — BPS - Bone Fragment Fixation Plates, Screws and Washers · Orthonovis, Inc. · Feb 6, 2025
K250952 — Baby Gorilla®/Gorilla® Plating System · Paragon 28, Inc. · Jul 18, 2025
K213591 — ANTHEM® Fracture System · Globus Medical, Inc. · Jan 26, 2022

Submission Summary (Full Text)

{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) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | 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 System Trauma Pelvic Set System (Matta) | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Plate, Fixation, Bone and Screw, Fixation, Bone | | Regulation Description: | 21 CFR 888.3030: Single/Multiple component metallic bone fixation appliances and accessories 21 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 GMBH Bohnackerweg 1 2545 Selzach, Switzerland | | Contact Person: | Danielle Jannuzzi Madureira, PhD Associate Manager Regulatory Affairs Dr. Homer Stryker Strasse, 1 CH-2545 Selzach, Switzerland Phone: +41 79 890 02 89 Fax: +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 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. | | Indications for Use: | 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 | | Comparison to Predicate Device: | A comparison of the system demonstrated that the subject PRO Plating System is substantially equivalent to the PRO Plating System, Stryker Trauma 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 Trauma Pelvic Set (Matta) is substantially equivalent to the Stryker Trauma Pelvic Set (Matta) regarding intended use, material, design, and operational principles. | | Performance Data (Nonclinical): | Non-Clinical Performance and Conclusions: The following non-clinical laboratory testing, and performance assessments were made in support of substantial equivalence: • Single Cycle Bend and Bending Fatigue Testing per ASTM F382 Tests performed to establish compatibility with a magnetic resonance environment: • Magnetically Induced Displacement per ASTM F2052 • Magnetically Induced Torque per ASTM F2213 • RF Heating per ASTM F2182 • Image Artifacts per ASTM F 2119 Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device. | | Conclusion: | Except for the modifications described in this submission the subject devices are identical to the predicate device, and the performance data and analyses demonstrate that any differences do not raise new questions of safety and effectiveness as established with performance testing and therefore, the subject devices PRO Plating System and Stryker Trauma Pelvic Set (Matta) is substantially equivalent to the previously cleared predicate device PRO Plating System and Stryker Trauma Pelvic Set (Matta) | {5}------------------------------------------------