CoLink View Plating System

K182402 · In2bones USA, LLC · HRS · Sep 27, 2018 · Orthopedic

Device Facts

Record IDK182402
Device NameCoLink View Plating System
ApplicantIn2bones USA, LLC
Product CodeHRS · Orthopedic
Decision DateSep 27, 2018
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3030
Device ClassClass 2
AttributesTherapeutic, Pediatric

Intended Use

The In2Bones USA LLC, CoLink® Plating System/CoLink® View Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the hand, wrist, foot and ankle in both pediatric and adult patients. The In2Bones USA LLC, CoLink® Afx Plating System is indication and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.

Device Story

The CoLink View Plating System consists of bone plates and screws used for orthopedic fracture fixation and reconstruction. The system is a modification of previously cleared devices, specifically changing the supplier of PEEK material inserts from Evonik Industries to Invibio Biomaterial Solutions. The device is used by orthopedic surgeons in clinical settings. The system provides mechanical stabilization of bone segments to facilitate healing. No design changes were made to the implants, and the surgical instruments remain identical to those previously cleared. The device benefits patients by providing rigid fixation for small bone fractures and osteotomies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises metallic bone plates and screws with PEEK inserts. Materials include ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V ELI) and ASTM F 2026 PEEK. The device is a mechanical fixation system; no software, electronics, or energy sources are involved.

Indications for Use

Indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies, and reconstruction of small bones in the hand, wrist, foot, and ankle, and ankle fractures (including tibia/fibula) in pediatric and adult patients.

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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font. In2Bones USA, LLC Christine Scifert Senior Director of Regulatory Affairs 6060 Poplar Ave. Suite 380 Memphis. Tennessee 38119 September 27, 2018 ## Re: K182402 Trade/Device Name: CoLink View Plating 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: August 31, 2018 Received: September 4, 2018 Dear Christine Scifert: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/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, # Jesse Muir -S 2018.09.27 18:49:41 -04'00' For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) ### K182402 Device Name CoLink(r) View Plating System Indications for Use (Describe) The In2Bones USA LLC, CoLink® Plating System/CoLink® View Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the hand, wrist, foot and ankle in both pediatric and adult patients. The In2Bones USA LLC, CoLink® Afx Plating System is indication and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients. 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) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ 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 CoLink® View Plating System Special 510(k) September 25, 2018 | Company: | In2Bones USA, LLC<br>6060 Poplar Ave, Suite 380<br>Memphis, TN 38119<br>901-260-7931 | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact: | Christine Scifert | | Trade Name: | CoLink® View Plating System | | Common Name: | Plate, Fixation, Bone<br>Screw, Fixation, Bone | | Classification: | II | | Regulation Number: | 888.3030 - Single/multiple component metallic bone fixation appliances<br>and accessories<br>888.3040 - Smooth or threaded metallic bone fixation fastener | | Panel: | 87-Orthopedic | | Product Code(s): | HRS, HWC | The In2Bones CoLink® Plating System is a system of plates and screws and Device Description: surgical instruments used to treat fracture and reconstruction of the extremities. Previous clearances include plates made from F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V ELI) material (K163293) and plates that include inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK) or ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V ELI) materials (K172300). The PEEK material cleared previously was from the supplier, Evonik Industries. The scope of this submission is to modify the supplier of the PEEK material from Evonik Industries to Invibio Biomaterial Solutions. There is no design change to the implants and the instruments used with the system are identical. The Invibio PEEK material meets ASTM F 2026. Indications for Use: The In2Bones USA LLC, CoLink® Plating System/CoLink® View Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, {5}------------------------------------------------ osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. The In2Bones USA LLC, CoLink® Afx Plating System is indicated for stabilization and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients. Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA: Primary Predicate - K172300 InBones USA CoLink™ View Plating System . Additional Predicates - K163293 In2Bones USA CoLink™ Plating System . Reference Predicates - K181113 In2Bones USA CoLink™ Afx Plating System ● - K173616 In2Bones SAS DIP Arthrodesis System ● The subject PEEK components from CoLink® View Plating System have been shown to be substantially equivalent to the previously cleared devices cleared under K163293 and K172300 as the products are identical in indications, materials and geometry. Performance Testing: No additional mechanical testing or validations were required to establish substantial equivalence. #### Conclusion Based on the material information provided for Invibio and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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