MatrixRIB Fixation System

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DePuy Synthes Francoise Cettour-Delbart Senior RA Program Lead 1301 Goshen Parkway West Chester, Pennsylvania 19380 May 3, 2019 ## Re: K190409 Trade/Device Name: MatrixRIB Fixation System 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: February 20, 2019 Received: February 21, 2019 Dear Francoise Cettour-Delbart: 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. 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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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). 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Sincerely, For CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K190409 Device Name MatrixRIB Fixation System #### Indications for Use (Describe) The DePuy Synthes MatrixRIB Fixation System is indicated for use in skeletally mature patients with normal or osteoporotic bone for chest wall fixation, where: DePuy Synthes MatrixRIB pre-contoured plates are indicated for the fixation, stabilization and reconstruction of: - · Rib fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects - · Pectus Excavatum, Pectus Carinatum, and other chest wall deformities DePuy Synthes MatrixRIB straight plates are indicated for the fixation, stabilization and reconstruction of: - · Rib and sternum fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects - · Pectus Excavatum, Pectus Carinatum, and other chest wall deformities DePuy Synthes MatrixRIB sternal plates, 2.8mm thickness, are indicated for fixation, stabilization and reconstruction of: · Sternum fractures, fusions, and/or osteotomies - · Pectus Excavatum, Pectus Carinatum, and other chest wall deformities The DePuy Synthes MatrixRIB intramedullary splints and the universal plate are indicated for the fixation and stabilization of ribs. ## Contraindications The MatrixRIB Fixation System is contraindicated for: - · The fixation of the sternum in acute cardiac patients, due to the potential delay if emergent re-entry is required - · Screw attachment or fixation to the clavicle or spine · Use in patients with latent or active infection, with sepsis, or who are unwilling or incapable of following postoperative care instructions. 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." {3}------------------------------------------------ # 510(k) Summary | Sponsor: | DePuy Synthes<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>USA | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Primary Contact: Françoise Cettour-Delbart<br>Email: fcettour@its.jnj.com | | | Phone: +41 61 965 6765 | | | Alternate Contact: Thomas Shea | | | Email: tshea@its.jnj.com<br>Phone: 610-719-5679 | | Date Prepared: | April 25, 2019 | | Subject Device Name: | MatrixRIB Fixation System | | Common<br>or Usual Name: | Plate, Fixation, Bone;<br>Screw, Fixation, Bone | | Classification Name: | Single/multiple component metallic bone fixation appliances and accessories;<br>Smooth or threaded metallic bone fixation fastener | | Classification: | Class II<br>Regulation Number: 21 CFR 888.3030; 21 CFR 888.3040<br>Product Code: HRS, HWC | | Predicate Device: | Biomet Microfixation RibFix Blu Thoracic Fixation System<br>(K162974) | | Reference Device: | Synthes MatrixRIB Fixation System<br>(K161590) | | Subject Devices<br>Description: | The devices subject to this notification are proposed for addition to the MatrixRIB<br>Fixation System. | | | The subject devices consist of self-drilling screws and screw guides designed to be<br>used with the previously cleared MatrixRIB 1.5mm plates and the splints. | | | The MatrixRIB Self-Drilling Screws are available as<br>• locking screws, for permanent fixation,<br>• and non-locking screws, for temporary fixation only.<br>The subject screws are manufactured from Titanium Alloy (Ti-6Al-7Nb). They are<br>provided in a range of lengths<br>• locking: 13 lengths from 8mm to 20mm, with 1mm increments;<br>• non-locking: 2 lengths from 10mm to 12 mm, with 2 mm increments). | | | The MatrixRIB Screw Guides are to be used with the subject self-drilling screws to<br>facilitate their fixation on patient's ribs and sternum. The subject screw guides<br>are manufactured from Stainless Steel and are provided in 2 designs,<br>• one for the 1.5mm MatrixRIB plates,<br>• and one for the MatrixRIB IM splints. | | Subject Devices<br>Indications for use: | The DePuy Synthes MatrixRIB Fixation System is indicated for use in skeletally<br>mature patients with normal or osteoporotic bone for chest wall fixation, where: | | | DePuy Synthes MatrixRIB pre-contoured plates are indicated for the fixation,<br>stabilization and reconstruction of:<br>• Rib fractures, fusions, osteotomies, and/or resections, including spanning | | | gaps and/or defects<br>• Pectus Excavatum, Pectus Carinatum, and other chest wall deformities | | | DePuy Synthes MatrixRIB straight plates are indicated for the fixation, stabilization<br>and reconstruction of: | | | • Rib and sternum fractures, fusions, osteotomies, and/or resections, including<br>spanning gaps and/or defects | | | • Pectus Excavatum, Pectus Carinatum, and other chest wall deformities | | | DePuy Synthes MatrixRIB sternal plates, 2.8mm thickness, are indicated for the<br>fixation, stabilization and reconstruction of: | | | • Sternum fractures, fusions, and/or osteotomies | | | • Pectus Excavatum, Pectus Carinatum, and other chest wall deformities | | | The DePuy Synthes MatrixRIB intramedullary splints and the universal plate are<br>indicated for the fixation and stabilization of ribs. | | | Contraindications | | | The MatrixRIB Fixation System is contraindicated for: | | | • The fixation of the sternum in acute cardiac patients, due to the potential delay<br>if emergent re-entry is required | | | • Screw attachment or fixation to the clavicle or spine | | | • Use in patients with latent or active infection, with sepsis, or who are unwilling<br>or incapable of following postoperative care instructions. | | Comparison to<br>Predicate Device: | The predicate device is part of the Biomet Microfixation System. | | | Indications: | | | The Biomet Microfixation System is indicated for use in the stabilization and<br>fixation of fractures in the chest wall including sternal reconstructive surgical<br>procedures, trauma, or planned osteotomies. The system may be used in normal<br>and poor bone to promote union. | | | Proposed MatrixRIB screws have a bone thread major diameter of 2.7 mm and the predicate RibFix Blu screws come in two bone thread major diameters, 2.4 mm and 2.7mm. Proposed MatrixRIB are offered in lengths from 8mm to 20mm, and the predicate RibFix Blu screws are offered in lengths from 7mm to 16mm. | | | Technological Differences between the MatrixRIB Self-Drilling Screws and the<br>Biomet Microfixation Self-Drilling Screws:<br>The proposed MatrixRIB self-drilling screws are designed to be inserted with the<br>aid of a Screw Guide to ensure proper alignment, while the predicate RibFix Blu<br>self-drilling screws are inserted without the aid of a Screw Guide.<br>The proposed MatrixRIB Fixation System offers a non-locking version of the self-<br>drilling screw for temporary fixation of the rib plate to the bone; while the<br>predicate RibFix Blu system offers a temporary fixation screw to secure the rib<br>plate to the bone<br>The proposed MatrixRIB self-drilling screws are manufactured from Ti-6Al-7Nb<br>while the predicate RibFix Blu self-drilling screws are manufactured from Ti-6Al-<br>4V. | | Non-clinical<br>Performance Data: | Non-clinical testing and analyses conducted as part of this submission include: Screw Pull-Out Testing per ASTM F543-17 Screw Failure Torque Testing per ASTM F543-17 Screw Cantilever Load Testing Construct Dynamic Testing. The non-clinical performance data demonstrates that the mechanical performance of the proposed MatrixRIB Self-Drilling Screws met all acceptance criteria and is comparable to that of the predicates. | | Clinical | Clinical testing was not necessary for the determination of substantial | {4}------------------------------------------------ {5}------------------------------------------------ Contraindications: - 1. Spanning a midline sternotomy - 2. Active infection - 3. Foreign body sensitivity - 4. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. Technological similarities between the MatrixRIB Self-Drilling Screws and the Biomet Microfixation Self-Drilling Screws: Same principles of operation between the proposed and predicate screws, i.e. metallic screws with a self-drilling tip designed to be inserted into a rib without pre-drilling a hole, and a thread profile on the head of the screw designed to lock to a fixation plate. Similar sizes compared to the predicates: Performance Data: equivalence. {6}------------------------------------------------ #### The subject device has similar intended use compared to the predicate device. Substantial Equivalence: The non-clinical performance data included in this submission supports that any differences in technological characteristics from the predicate device do notraise any new questions of safety and effectiveness. lt is concluded that the information provided in this submission supports substantial equivalence.