CC-Clip® Implant System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The Department of Health & Human Services logo is a stylized representation of a human figure. June 28, 2024 CC-Instruments Inc % Mason Makulinski Project Engineer Jalex Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145 Re: K232780 Trade/Device Name: CC-Clip® Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dear Mason Makulinski: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on December 18, 2023. Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction. Please see the attached revised clearance letter. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Limin Sun, OHT6: Office of Orthopedic Devices, 301-796-7056, Iimin.sun@fda.hhs.gov. Sincerelv. # Christopher Ferreira -S for Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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. June 28, 2024 CC-Instruments Inc % Mason Makulinski Project Engineer Jalex Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145 Re: K232780 Trade/Device Name: CC-Clip® Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: September 11, 2023 Received: September 11, 2023 Dear Mason Makulinski: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on December 18, 2023. 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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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 {2}------------------------------------------------ Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {3}------------------------------------------------ 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, # Christopher Ferreira -S for Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### Indications for Use 510(k) Number (if known) #### K232780 Device Name CC-Clip® Implant System #### Indications for Use (Describe) The CC-Clip® device is intended as an adjunct in coracoclavicular ligament disruption repair. Specifically, the CC-Clip® device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Page 1 of 4 510(k) Submission - CC-Clip® Implant System K232780 ## 510(k) Summary In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the CC-Clip® Implant System. | Submitted By: | CC-Instruments Inc.<br>850 New Burton Road, Suite 201<br>Dover, Delaware 19904 | |-------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | Date: | 18DEC2023 | | Contact Person:<br>Contact Telephone:<br>Contact Fax: | Mason Makulinski, Project Engineer<br>(440) 242-9127<br>(440) 933-7839 | | Device Trade Name: | CC-Clip® Implant System | | Common Name:<br>Device Classification Name: | Button/Suture<br>21 CFR 888.3030, Single/multiple bone fixation appliances and<br>accessories | | Device Classification:<br>Reviewing Panel:<br>Product Code: | Class II<br>Orthopedic<br>HTN | | Primary Predicate Device: | Arthrex TightRope® Acromioclavicular (AC) device (K052776) | #### Device Description: CC-Clip® is an implantable device for an arthroscopic coracoclavicular (CC) ligament reconstruction and acromioclavicular (AC) ligament reconstruction technique. The original ligaments fail due to an AC joint separation and cause superior and posterior translation of the clavicle. CC-Clip® device consists of a titanium implant on the clavicle, a titanium counterpart under the coracoid, and non-resorbable suture between the implants. A USP size 5 suture is not provided with CC-Clip®, but the Arthrex #5 FiberWire is recommended with the CC-Clip® device. Instrumentation included with the CC-Clip® system includes two instruments: the CC-Clip® Straight Lasso guide and CC-Clip® Curved Lasso guide. Additional general-use, readily available instrumentation required for the CC-Clip® procedure includes lasso wire, guide pins, and drill bits which are to be supplied by the end user per the surgical technique. Both CC-Clip® guides are re-usable surgical instruments provided non-sterile to the user. The CC-Clip® implants are supplied sterile to the user and are single use. #### Indications for Use: The CC-Clip® device is intended as an adjunct in coracoclavicular ligament disruption repair. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a metal clip on the left and the text "CC-CLIP" on the right. The clip is a small, U-shaped piece of metal with a flat top. The text is in a sans-serif font and is gray in color. The text is slightly larger than the clip. K232780 Page 2 of 4 Specifically, the CC-Clip® device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions. #### Summary of Technological Characteristics: The CC-Clip® Implant System is similar in its intended use to the predicate device, Arthrex TightRope® Acromioclavicular (AC) device System. The proposed devices are composed of two buttons that are fabricated from titanium alloy per ASTM F136, and the design features for the implant system are similar to the predicate device, including dimensions, shape, and sizes. #### Performance Data - Nonclinical: Substantial equivalence is supported by the results of mechanical testing including engineering analysis of static (ultimate load) and dynamic testing. | Table 6.1. Mechanical Testing Program for CC-Clip Implant System | | |------------------------------------------------------------------|------------| | Verification Method | Results | | Static Testing | Acceptable | | Dynamic Testing | Acceptable | ### oblo 6 1, Mochanicol Tosting Program for CC Clip® Implont System Testing performed on the CC-Clip® Implant System demonstrated that all performance-based requirements and acceptance criteria were met to support safety and effectiveness and is considered substantially equivalent to the predicate device. #### Performance Data - Clinical: Clinical testing is not required and therefore not conducted as part of this submission. #### Substantial Equivalence: The CC-Clip® Implant System has the same intended use and fundamental scientific technology as the Arthrex TightRope® Acromioclavicular (AC) device (K052776) primary predicate device. Both devices compare similarly in: - Design features and instrumentation - Intended use and indications for use - Material composition - Dimensions - Function ● - . Sterilization methods Refer to Table 8.2 below for additional information. The potential impact on substantial equivalence of each technological difference was addressed through risk analysis and verification and validation testing. Any differences between the CC-Clip® Implant System and the predicate device do not raise any questions of safety and effectiveness. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a metal clip on the left and the text "CC-CLIP" on the right. The clip is a small, U-shaped piece of metal with a flat top. The text is in a sans-serif font and is gray in color. The text is slightly larger than the clip. ## 510(k) Submission – CC-Clip® Implant System K232780 Page 3 of 4 The table below summarizes the features of the subject device and its equivalence to the predicate device. | Table 8.2 Subject and Predicate Device Comparison | | | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device:<br>CC-Clip® Implant System | Predicate Device:<br>Arthrex TightRope®<br>Acromioclavicular (AC) device | | Regulation Name | Single/multiple component metallic<br>bone fixation appliances and<br>accessories | Single/multiple component metallic<br>bone fixation appliances and<br>accessories | | Regulation<br>Number | 21 CFR 888.3030 | 21 CFR 888.3030 | | Product Code | HTN | HTN | | Device<br>Description | CC-Clip® is an implantable device for<br>an arthroscopic coracoclavicular (CC)<br>ligament reconstruction and<br>acromioclavicular (AC) ligament<br>reconstruction technique. The original<br>ligaments fail due to an AC joint<br>separation and cause superior and<br>posterior translation of the clavicle.<br><br>CC-Clip® device consists of a titanium<br>implant on the clavicle, a titanium<br>counterpart under the coracoid, and<br>non-resorbable suture between the<br>implants. Suture is not provided with<br>CC-Clip®, but the Arthrex #5<br>FiberWire is recommended with the<br>CC-Clip® device.<br><br>Instrumentation included with the CC-<br>Clip® system includes two<br>instruments: the CC-Clip® Straight<br>Lasso guide and CC-Clip® Curved<br>Lasso guide. Additional general-use,<br>readily available instrumentation<br>required for the CC-Clip® procedure<br>includes lasso wire, guide pins, and<br>drill bits which are to be supplied by<br>the end user per the surgical<br>technique. Both CC-Clip® guides are<br>re-usable surgical instruments<br>provided non-sterile to the user. The<br>CC-Clip® implants are supplied sterile<br>to the user and are single use. | The TightRope™ Acromioclavicular<br>(AC) Device is designed as two<br>differently sized metal buttons, both<br>stainless steel or both titanium, and<br>FiberWire™ suture. The buttons are<br>pre-threaded with FiberWire Suture,<br>looped twice through the buttonholes.<br>Pull-Through FiberWire sutures are<br>also looped through each button.<br><br>The TightRope™ Acromioclavicular<br>(AC) Device is intended as an adjunct<br>in fracture repair involving<br>metaphyseal and periarticular small<br>bone fragments where screws are not<br>indicated, and as an adjunct in external<br>and intramedullary fixation systems<br>involving plates and rods, with fracture<br>braces and casting. Specifically, the<br>Arthrex TightRope Acromioclavicular<br>(AC) Device is intended to provide<br>fixation during the healing process<br>following a syndesmotic trauma, such<br>as fixation of acromioclavicular<br>separations due to coracoclavicular<br>ligament disruptions. | | Indications for<br>Use | The CC-Clip® device is intended as<br>an adjunct in coracoclavicular<br>ligament disruption repair. | The TightRope™ Acromioclavicular<br>(AC) Device is intended as an adjunct<br>in fracture repair involving<br>metaphyseal and periarticular small bone | | | Specifically, the CC-Clip® device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions. | fragments where screws are not indicated and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.<br>Specifically, the Arthrex TightRope Acromioclavicular (AC) Device is intended to provide fixation during syndesmotic trauma, such as fixation of acriomioclavicualr separations due to coracoclavicular ligament disruptions. | | Device Model | Image: CC-Clip Device Model | Image: Arthrex TightRope Acromioclavicular (AC) Device | | Material | Implants: Titanium Alloy<br>Instruments: Stainless Steel | Implants: Titanium Alloy and stainless steel | | Sterilization | Implants: Gamma Radiation<br>Instruments: End User cleaning and steam sterilization | Unknown | | Clavicle Clip Sizes | 16mm and 20mm Length | Unknown | | Coracoid Clip Sizes | 10mm and 12mm Round<br>10mm and 12mm Rectangular | Unknown | | Suture Size Indication | #5 Suture | #5 Suture | ## Table 8,2 Subject and Predicate Device Comparison {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the words "CC-CLIP" in a sans-serif font. To the left of the text is a diagram of a metal clip. The text and diagram are in gray. The image is simple and clear. ## 510(k) Submission – CC-Clip® Implant System #### Conclusion: The CC-Clip® Implant System is as safe and effective as its predicate device, as it has the same intended use, indication for use, material composition, design features, manufacturing method, sterilization method, performance requirements and principles of operation as the primary predicate device (K052776). The design differences do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. Non-clinical testing demonstrates that the CC-Clip® Implant System is substantially equivalent to the primary predicate device.