PRECICE® BONE TRANSPORT™ System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services logo. The FDA logo features the agency's acronym in a blue square, followed by the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The Department of Health & Human Services logo is on the left side of the image and features a symbol with three stylized human profiles. The logos are placed side by side. NuVasive Specialized Orthopedics, Inc. Regualtory Affairs Specialist 101 Enterprise. Suite 100 February 5, 2019 # Re: K182170 Aliso Viejo, California 92656 Vidhi Bhatt Trade/Device Name: PRECICE® BONE TRANSPORT™ System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, HWC Dated: September 21, 2018 Received: September 24, 2018 Dear Vidhi Bhatt: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Daniel S. Ramsey -S 2019.02.05 16:31:33 -05'00' FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182170 Device Name PRECICE® BONE TRANSPORT™ System Indications for Use (Describe) The PRECICE® BONE TRANSPORT™ System is indicated for limb-lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions or bone transport of long bones. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------|---------------------------------------------| | <div><span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Below "NUVASIVE", the words "SPECIALIZED ORTHOPEDICS, INC." are written in a smaller, simpler font. ## PRECICE® Bone Transport System 510(k) Summary - K182170 In accordance with Title 21 of the Code of Federal Regulations. Part 807, and in particular 21 CFR \$807.92, the following summary of information is provided: #### Submitted by: A. Vidhi Bhatt Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Telephone: (949) 563-0655 Date Prepared: February 5, 2019 #### B. Device Name | Trade or Proprietary Name: | PRECICE® Bone Transport System | |----------------------------|------------------------------------------------------------------------| | Common or Usual Name: | Intramedullary Fixation Rod | | Classification Name: | Rod, Fixation, Intramedullary and Accessories<br>Screw, Fixation, Bone | | Device Class: | Class II | |-----------------|-------------------| | Classification: | 21 CFR § 888.3020 | | Product Code: | HSB, HWC | #### C. Predicate Devices | Predicate Device | PRECICE® System (K173129) | |------------------|----------------------------------| | Reference Device | PRECICE® Stryde System (K180503) | #### D. Device Description The PRECICE® Bone Transport System includes the PRECICE® Bone Transport Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE® Bone Transport nails and end caps are supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression of the intercalary bone segment and providing internal fixation for fractures of long bones. The PRECICE® Bone Transport intramedullary nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE® Bone Transport nail contains an enclosed rare earth magnet, distraction rod, and planetary gearing which allows the extension of the distraction rod to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE® Bone Transport nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and gray graphic to the left of the company name. The text "NUVASIVE" is in a sans-serif font, and below it, in smaller letters, is "SPECIALIZED ORTHOPEDICS, INC." The purpose of this submission is to implement design changes to the predicate PRECICE® System (K173129) and reference device PRECICE® Stryde System (K180503) to create a product line extension which includes the PRECICE® Bone Transport nail and compatible locking screws and end caps. The subject nail performance meets predicate device performance specifications. The design changes of subject nail inform revised contraindications, warnings. precautions and implantation procedure on the label to address new risks compared to predicate device. These modifications to the PRECICE® System do not change the indications for use or intended use of the device, nor do they change the fundamental scientific technology of the device. #### E. Indication for Use The PRECICE® Bone Transport System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, or bone transport of long bones. #### F. Comparison of Technological Characteristics with the Predicate Device The subject PRECICE® Bone Transport System is substantially equivalent to the predicate PRECICE® System (K173129) and reference device PRECICE® Stryde System (K180503) previously cleared by the FDA for commercial distribution in the United States. Substantial equivalence between subject, predicate and reference device is established based on identical indications for use, material composition, technological characteristics, principles of operation and fundamental scientific principles. Substantial equivalence is also based on device dimension, specifically, the nail diameters, locking screws, device configurations and end caps which are the same as the reference device. The predicate, reference and subject devices are inserted into the intramedullary canal of the long bones and secured with locking screws. The predicate, reference and subject devices are adjusted non-invasively by the External Remote Controller (ERC). The design modifications for the subject device, PRECICE® Bone Transport are as follows: - . The subject nail is a slotted intramedullary (IM) nail. The housing tube of this IM nail has longitudinal transport slot. - . The stroke length/transport length is independent of rod length since the distraction rod excursion is accommodated within the housing tube making the subject device a fixed length device. - The distraction rod spans both the defect site and osteotomy site. - Additional size of locking screw available with the subject device . - Assembly of the gear train and distraction rod is reversed to incorporate the transport slot ● although the components remain the same as the predicate device The labeling changes includes added contraindication and warning based on the design modifications of the subject device. There are no changes being made to the ERCs or PRECICE® surgical instruments as a result of this submission. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and gray graphic on the left, followed by the word "NUVASIVE" in gray, sans-serif font. Below "NUVASIVE" is the text "SPECIALIZED ORTHOPEDICS, INC." in a smaller, sans-serif font, also in gray. Conclusions can be drawn from these comparisons that the subject PRECICE® Bone Transport System is substantially equivalent to the predicate device. #### G. Performance Data Nonclinical performance verification testing was performed to demonstrate that the subject PRECICE® Bone Transport System is substantially equivalent to the predicate PRECICE® device. The following testing shows that the subject device conforms to the following standards, practices and guidance: | Testing Description | Applicable Standard | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Static Compression<br>Bending Strength | ASTM F1264 - Standard Specification<br>and Test Methods for Intramedullary<br>Fixation Devices | | Dynamic Compression<br>Bending strength | | | Torsion | | | Torque Resistance | ASTM F543 - Standard Specification and<br>Test Methods for Metallic Medical Bone<br>Screws | | Axial Pullout | | | Biocompatibility | ISO 10993- Biological evaluation of<br>medical devices | | Sterilization | Gamma Irradiation Sterilization Testing:<br>VDmax 25 kGy method per IS/EN/ISO<br>11137-1:2015 and IS/EN/ISO 11137-<br>2:2015 | | Package Distribution | ASTM D4169-16 Standard Practice for<br>Performance Testing of Shipping<br>Containers and Systems | In addition, the device also underwent the following performance testing to show that all requirements have been met: - >> Distraction Force Testing - Retention Force Testing A - A Fluid Ingress Testing - Biomechanical Axial Compression Testing A The results demonstrate that the subject PRECICE® Bone Transport System is substantially equivalent to the predicate device. #### H. Conclusions The subject PRECICE® Bone Transport System has been shown to be substantially equivalent to the legally marketed predicate device for its intended use.