AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws

{0}------------------------------------------------ September 16, 2019 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. Industrias Medicas Sampedro S.A.S Liliana Zuluaga-Idarraga Technical Director Carrera 47 No. 100 Sur 40 La Estrella, 055468 CO Re: K191641 Trade/Device Name: AFFINITY - Variable Angle Distal Radius System, AFFINITY - Variable Angle Distal Radius Plates, AFFINITY - Variable Angle Distal Radius Screws 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: June 14, 2019 Received: June 19, 2019 Dear Liliana Zuluaga-Idarraga: 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 {1}------------------------------------------------ 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, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191641 Device Name AFFINITY - Variable Angle Distal Radius System Indications for Use (Describe) AFFINITY - Variable Angle Distal Radius System is indicated for the fixation of simple and complex intra- articular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------|--| | <div> <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | | | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </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}------------------------------------------------ #### 510(k) Summary The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92. ### Submission date Date of the Traditional 510(k) submission is 28th August 2019. # Submitter information | Company name | Industrias Médicas Sampedro S.A.S | |-----------------------------------|-----------------------------------| | Establishment registration number | N/A | | Street Address | Carrera 47 No. 100 Sur 40 | | City | La Estrella | | Zip code | 055468 | | Country | Colombia | | Phone number | +5743223375 | | Fax number | +574 338 3013 | | Principal contact person | Liliana Zuluaga-Idárraga | | Contact title | Technical Director | | Contact e-mail address | liliana.zuluaga@imsampedro.com | | Additional contact person | Daniela Villa-Moreno | | Contact title | Regulatory Affairs Coordinator | | Contact e-mail address | daniela.villa@imsampedro.com | # Submission information | Trade name | AFFINITY - Variable Angle Distal Radius System | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common or Usual name | Plate, Fixation, Bone<br>Screw, Fixation, Bone | | Classification name | 21 CFR 888.3030; Single/multiple component metallic bone<br>fixation appliances and accessories<br>21 CFR 888.3040; Smooth or threaded metallic bone fixation<br>fastener | | Product code (classification regulation) | HRS<br>HWC | | Classification Panel | Orthopedic | | Device class | Class II | {4}------------------------------------------------ ### Predicate device The predicate device to which substantial equivalence is claimed to: | Trade or proprietary or model name | VariAx Distal Radius Plating System, VariAx 2 System | |------------------------------------|------------------------------------------------------| | 510(k) number | K162841 | | Decision date | 02/21/2017 | | Product code | HRS | | | HWC | | Manufacturer | Stryker GmbH | | Review Panel | Orthopedic | #### Reference device Trade or proprietary or model name 510(k) number Decision date Product code Manufacturer Review Panel Distal Volar Radius Anatomical plate system K050932 04/26/2005 LXT Hand Innovations, Inc Orthopedic ## Device Description The AFFINITY - Variable Angle Distal Radius System is contains a set of titanium plates and screws that are intended to be end-user sterilized. The AFFINITY - Variable Angle Distal Radius System plates are provided in different configurations and are intended to be used in combination with the variable angle drilling guide and the Styloid hole variable angle drill guide to provide the necessary angulation for optimal screw positioning. The system includes Extra-articular plates (intermediate, wide, and narrow), Distal dorso-ulnar and dorso-radial L-plates, Distal ulnar T-plates, and straight Radius styloid plates. # Indications for Use AFFINITY - Variable Angle Distal Radius System is indicated for the fixation of simple and complex intraarticular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3. {5}------------------------------------------------ | Characteristic | Subject device: | Predicate device: | Reference device: Distal Vola | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | | AFFINITY - Variable Angle<br>Distal Radius System (Plates<br>and Screws) | VariAx Distal Radius Plating<br>System, VariAx 2 System<br>(K162841) | Radius Anatomical plate<br>system (K050932) | | Product code | HRS, HWC | HRS, HWC | LXT | | Classification | Class II. 21 CFR 888.3030;<br>Single/multiple<br>component metallic bone<br>fixation appliances and<br>accessories<br>21 CFR 888.3040; Smooth<br>or threaded metallic bone<br>fixation fastener | Class II. 21 CFR 888.3030;<br>Single/multiple component<br>metallic bone fixation<br>appliances and accessories<br>21 CFR 888.3040; Smooth or<br>threaded metallic bone<br>fixation fastener | Class II. 21 CFR 888.3030;<br>Single/multiple<br>component metallic bone<br>fixation appliances and<br>accessories | | Intended Use | Fixation of simple and complex<br>intra-articular and extra-<br>articular fractures, and for<br>osteotomies of the distal<br>radius in adults. Fractures AO<br>types A2, A3, B1, B3, C1, C2,<br>C3. | VariAx Distal Radius Plating<br>System is intended for internal<br>fixation of small bone fracture,<br>primarily including distal<br>radius fractures. The VariAx 2<br>System is intended for internal<br>fixation. | Distal Volar Radius Anatomical<br>plate system is intended for<br>the fixation of fractures and<br>osteotomies involving the<br>distal radius. | | Fixation method | Screw | Screw | Screw | | Material(s) | Plates: biocompatible<br>commercially pure<br>titanium grade 4 (ASTM F67)<br>Screws: biocompatible<br>titanium alloy (Ti6Al4V) (ASTM<br>F136) | Plates: commercially pure<br>titanium grade 2 (ASTM F67)<br>Screws: titanium alloy (ASTM<br>F136) | Plates and Screws:<br>titanium alloy (ASTM F136) | | Manufacturing | Industrias Médicas Sampedro | Stryker Trauma GmbH | HAND INNOVATIONS, INC | | Sterilization | Steam Sterilization | Steam Sterilization | Steam Sterilization | | Patient-specific | NO | NO | NO | | Patient-specific<br>accessories? | NO | NO | NO | Comparison to the predicate and reference devices {6}------------------------------------------------ # Non-clinical Testing The following non-clinical testing was conducted as a basis for the determination of substantial equivalence: | Name | Test method | Conclusion | |-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Mechanical testing of the plates | ASTM F384-17 (Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices)<br><br>Annex 1 Static Bend Testing<br>Annex 2 Fatigue Bend Testing | Substantial equivalence | | Mechanical testing of the screws | ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws)<br><br>Annex 1 Torsional Properties<br>Annex 2 Driving Torque<br>Annex 3 Axial Pullout | Substantial equivalence | | Biocompatibility test overview | | | | Test / assessment description | Test report conclusion | | | Cytotoxicity:<br>ISO 10993-5: Tests for in-vitro cytotoxicity | no cytotoxic effect | | | Chemical characterization:<br>ISO 10993-18: Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Materials. | chemical characterization as per the report | | | Film-forming contaminations: XPS investigation | appropriate surface cleanliness | | | Detection and Quantification of Bacterial Endotoxins | no risk of bacterial pyrogenicity | | | Sterilization test overview | | | | Test / assessment description | Test report conclusion | | | Validating steam sterilization method according to ISO 11737-2:2009, ISO 17665-1:2006, ISO 14161:2009. | The results of the validating steam sterilization method show that the implants, accessories, and models can be sterilized to a SAL of 10-6 using the recommended steam sterilization instructions | | # Conclusion The non-clinical tests and technological comparisons demonstrate that the subject device is substantially equivalent to the predicate.