Traufix osteosynthesis, osteotomy, and arthrodesis devices

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date March 18, 2022. The text is written in a clear, sans-serif font. The date is written in the standard US format, with the month first, followed by the day and year. The text is centered and takes up most of the image. FDA U.S. FOOD & DRUG ADMINISTRATION Fixier, S.A. de C.V. % Aurelia Brownridge Regulatory Affairs Consultant Aurelia Brownridge 11594 Cesped Drive San Diego, California 92124 Re: K201510 Trade/Device Name: Traufix osteosynthesis, osteotomy, and arthrodesis devices 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 Dear Aurelia Brownridge: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 18, 2022. Specifically, FDA is updating this SE Letter as an administrative correction, as two copies of the SE letter were sent in error along with the Indications for Use statement for K201510, but not the 510(k) Summary. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shumaya Ali, M.P.H., OHT6: Office of Orthopedic Devices, (301) 796-2356, shumaya.ali@fda.hhs.gov. Sincerely, Shumaya Ali -S Shumaya Ali, MPH 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 {1}------------------------------------------------ February 18, 2022 Image /page/1/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. The FDA logo is on the right and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Fixier, S.A. de C.V. % Aurelia Brownridge Regulatory Affairs Consultant Aurelia Brownridge 11594 Cesped Drive San Diego, California 92124 Re: K201510 Trade/Device Name: Fixier osteosynthesis, osteotomy, and arthrodesis devices 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: January 15, 2022 Received: January 20, 2022 Dear Aurelia Brownridge: 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. {2}------------------------------------------------ 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 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, # Shumava Ali - Shumaya Ali, MPH 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201510 Device Name Traufix osteosynthesis, osteotomy, and arthrodesis devices #### Indications for Use (Describe) Traufix medical devices are intended for fixation of fractures and osteotomies of various bones including the pelvis, clavicle, scapula, humerus, ulna, radius, femur, tibia, olecranon, and fibula. | Type of Use (Select one or both, as applicable) | |---------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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 - K201510 The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92. 510(k) Bundle: This submission includes a range of Fixier's products with the same regulation classification and regulation code name. Date Summary Prepared: February 15, 2022 ## Manufacturer and Contact Information: | Submitter's<br>Name | Submitter's<br>Physical Address | Submitter's<br>Contact Information | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Fixier, S.A. de<br>C.V. | Carretera Doctor Mora a San Miguel<br>de Allende km 3.4, C.P. 37967<br>Comunidad de San Rafael, Doctor<br>Mora, Guanajuato, México | Primary Official Contact:<br>Aurelia Brownridge<br>Regulatory Affairs (Consultant)<br>Telephone: 760-497-4354<br>Secondary Contact:<br>Vianey Mariana Perez Suarez<br>Biological and Pharmaceutical<br>Chemistry<br>Regulatory Affairs Chief | | | | Telephone: 011-52-419-688-11-91 | ## Device and Classification Information: | Proprietary Name: | Traufix osteosynthesis, osteotomy, and arthrodesis devices | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Plate, Fixation, Bone (primary)<br>Screw, Fixation, Bone | | Classification Name: | Single/multiple component metallic bone fixation appliances and<br>accessories (primary)<br>Smooth or threaded metallic bone fixation fastener | | Regulatory Class: | II | | Product Codes: | HRS (primary)<br>HWC | | Regulation Number: | 21 CFR 888.3030 (primary)<br>21 CFR 888.3040 | {5}------------------------------------------------ Indications for Use: Traufix medical devices are intended for fixation of fractures and osteotomies of various bones including the pelvis, clavicle, scapula, humerus, ulna, radius, femur, tibia, olecranon, and fibula. Description: Traufix osteosynthesis medical devices are metal implants (stainless steel per ASTM F138, or ASTM F139, or titanium-alloy per ASTM F136) fixed adjacent to the bone for the treatment and consolidation of fractures, osteotomies, and/or joint ossification. The devices include different types and sizes of plates and screws. The product's list is shown below: | Plate<br>type | Plate<br>code | Plate<br>description | Screw<br>code | Screw description | Surgical<br>technique # | Surgical technique<br>name | |--------------------|-------------------------------------|-----------------------------------------------------------------|---------------|------------------------------------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------| | Mini<br>fragments | 017 | 2.7 DCP Plates | 064 | 2.7mm cortex screw | | DCP plates | | | 207 | 2.0 DCP Plates | 079 | 2.0mm cortex screw | TQ-005 | | | | 202<br>&<br>203 | 2.7mm L-plate | 064 | 2.7mm cortex screw | TQ-032 | T and L plates for<br>3.5mm, 2.7mm, and<br>2.0mm screws | | | 016 | 3.5mm One-<br>third tubular<br>plate | 057 | 3.5mm cortex screw | TQ-004 | 3.5mm One-third<br>tubular plate | | | | | 058 | 4.0mm cancellous screw<br>partially threaded | | | | | | | 059 | 4.0mm cancellous screw<br>fully threaded | | | | Small<br>fragments | 110,<br>111,<br>172,<br>&<br>173 | ALP titanium<br>distal tibia<br>plates TIDIS &<br>TIDIS-III | 112 | 3.5mm titanium cortex<br>screw | | ALP titanium distal<br>tibia plate<br>TIDIS I AND<br>TIDIS III | | | | | 106 | 3.5mm titanium cortex<br>locking screw | TQ-011 | | | | | | 107 | 3.5mm titanium<br>cancellous locking<br>screw | | | | | 129 | ALP titanium<br>proximal<br>humerus plate<br>PROH-LOCK<br>LARGE | 112 | 3.5mm titanium cortex<br>screw | TQ-014 | ALP titanium<br>humerus plate<br>PROH-LOCK and<br>PROH-LOCK<br>LARGE | | | | | 106 | 3.5mm titanium cortex<br>locking screw | | | | | | | 107 | 3.5mm titanium<br>cancellous locking<br>screw | | | | | 144<br>&<br>145 | ALP titanium<br>distal lateral<br>humerus plate<br>DH-LOCK | 112 | 3.5mm titanium cortex<br>screw | TQ-017 | ALP titanium distal<br>lateral humerus<br>plate and ALP<br>titanium<br>Distal medial<br>humerus plate DH-<br>LOCK | | | | | 106 | 3.5mm titanium cortex<br>locking screw | | | | | | | 107 | 3.5mm titanium<br>cancellous locking<br>screw | | | | | | | 170 | 2.7mm titanium cortex<br>locking screw | | | | | 148,<br>148S,<br>149,<br>&<br>149S. | ALP titanium<br>distal radius<br>plate LIONTER | 154X | 2.5mm titanium cortex<br>screw Torx drive | TQ-018 | ALP titanium distal<br>radius plate | | | | | 155X | 2.5mm titanium cortex<br>locking screw Torx<br>drive | | | {6}------------------------------------------------ | Fixier | |-----------------------------------------------------------| | Traufix osteosynthesis, osteotomy and arthrodesis devices | | Plate<br>type | Plate<br>code | Plate<br>description | Screw<br>code | Screw description | Surgical<br>technique # | Surgical technique<br>name | |--------------------|-----------------|--------------------------------------------------|---------------|----------------------------------------------------------|-------------------------|----------------------------------------------------| | | 164<br>&<br>165 | ALP titanium<br>distal tibia<br>plates TIDIS-III | 112 | 3.5mm titanium cortex<br>screw | TQ-023 | ALP titanium distal<br>plate TIDIS II | | | | | 106 | 3.5mm titanium cortex<br>locking screw | | | | | | | 107 | 3.5mm titanium<br>cancellous locking<br>screw | | | | | 023 | 4.5mm<br>Reconstruction<br>plates | 056 | 4.5mm cortex screw | TQ-009 | Reconstruction<br>plates | | | | | 060 | 6.5mm cancellous screw<br>16mm thread | | | | | | | 061 | 6.5mm cancellous screw<br>32mm thread | | | | | | | 062 | 6.5mm cancellous screw<br>fully threaded | | | | Large<br>fragments | 150<br>&<br>151 | ALP titanium<br>proximal femur<br>plate TLP | 126 | 4.5mm titanium cortex<br>screw | TQ-019 | ALP titanium<br>proximal femur<br>plate TLP | | | | | 108 | 5.0mm titanium cortex<br>locking screw | | | | | | | 171 | 5.0mm titanium<br>cannulated cortex<br>locking screw | | | | | | | 109 | 5.5mm titanium<br>cancellous locking<br>screw | | | | | | | 156 | 7.3mm titanium<br>cannulated cancellous<br>locking screw | | | | | 152<br>&<br>153 | ALP titanium<br>proximal tibia<br>plate OPTIMUS | 126 | 4.5mm titanium cortex<br>screw | TQ-020 | ALP titanium<br>proximal<br>Tibia plate<br>OPTIMUS | | | | | 108 | 5.0mm titanium cortex<br>locking screw | | | | | | | 109 | 5.5mm titanium<br>cancellous locking<br>screw | | | | Substantial<br>Equivalence: | Traufix osteosynthesis, osteotomy, and arthrodesis devices and<br>predicate devices have the same indications for use, target<br>population, patient contact, materials, and sterilization methods. | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Traufix subject devices, and predicate devices are intended for<br>fracture fixation and minor differences exist in the physical shape<br>and dimension characteristics of the plates and screws. However,<br>these minor dimensional differences do not raise any new<br>questions of safety or effectiveness. | | Primary Predicate<br>Device: | AUXEIN BRAND Of Bone Plates and Bone Screws & AUXEIN<br>BRAND Of DCS Plate System AUXEIN brand of Locking Plates<br>and Locking Screws, (K141680) | {7}------------------------------------------------ | Other Predicate<br>Devices: | -Synthes (USA) Modular Mini Fragment LCP System, (K063049)<br>-Synthes (USA) Medial Distal Tibia Plates, (K001945)<br>-Synthes Variable Angle Locking Compression Plate (VA-LCP),<br>(K071184)<br>-Synthes One-Third Tubular DCL Plate, (K011335)<br>-Synthes 4.5mm LCP Straight Reconstruction Plates, (K051986)<br>-Synthes (USA) LCP Proxima Humerus Plates, Long, (K041860) | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Non-Clinical<br>(Performance Testing): | -Non-clinical testing was performed in the subject devices as<br>follows:<br>-Single cycle bend testing was performed according to ASTM<br>F382.<br>-Breaking torque testing was performed according to ISO 6475.<br>-Engineering analysis was performed to compare the<br>structural properties per ASTM F382 A1 (bending stiffness,<br>bending structural stiffness, and bending strength) of the proximal<br>tibia plate (subject device) and proximal tibia plate (predicate<br>device one).<br>-Engineering analysis and comparison of technology was also<br>provided to compare design and dimensions of the subject and<br>predicate plates and screws. | | Clinical Testing: | Clinical testing is not a prerequisite, as osteosynthesis, osteotomy,<br>and arthrodesis implants conform to recognized standards and have<br>well established safety and performance characteristics. Therefore,<br>clinical information is not necessary to demonstrate safety and<br>effectiveness or substantial equivalence. | | Conclusion: | The Traufix osteosynthesis, osteotomy, and arthrodesis devices<br>have been found to be substantially equivalent to the predicate<br>devices. Differences between the subject devices and the predicate<br>devices do not raise new questions of safety or effectiveness. |