← Product Code [HWC](/productcode/HWC) · K252699 # CoAptix S System (K252699) _University of Utah, Department of Orthopaedics · HWC · Apr 10, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K252699 ## Device Facts - **Applicant:** University of Utah, Department of Orthopaedics - **Product Code:** [HWC](/productcode/HWC.md) - **Decision Date:** Apr 10, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The CoAptix S System is intended for the fixation of bone fractures, fusions, osteotomies, reconstructions, non-unions, and malunions in adults. The System is indicated for long bones and long bone fragments, pelvic bones (including the sacrum), and the foot. ## Device Story CoAptix S System consists of metallic bone screws (headed and headless) and optional washers; used for bone fixation in fractures, fusions, osteotomies, reconstructions, non-unions, and malunions. Screws are cannulated to facilitate precise placement over guidewires. Device is used in clinical/surgical settings by orthopedic surgeons. Implants provide mechanical stabilization of bone segments to facilitate healing. Performance characterized by mechanical testing (torsion, pull-out, bending) and corrosion analysis. ## Clinical Evidence No clinical or animal testing was conducted. Performance was established through bench testing, including torsional strength, driving torque, axial pull-out strength, static/dynamic bending, pitting corrosion, galvanic corrosion, fretting corrosion, and Af testing per ASTM standards. ## Technological Characteristics Materials: Ti-6Al-4V (ASTM F136) and Nitinol (ASTM F2063). Design: Cannulated metallic bone screws (headed/headless) with optional washers. Mechanical testing performed per ASTM F543, ASTM F1264, ASTM F2129, ASTM G102, ASTM F3044, and ASTM F2082. ## Regulatory Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - DePuy Synthes Cortex and Cannulated Screws ([K161616](/device/K161616.md)) - MedShape DynaFuse Fixation System ([K203595](/device/K203595.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION April 10, 2026 University of Utah, Department of Orthopaedics % Dave Mcgurl Vice President, Orthopedic Regulatory Affairs MCRA, LLC 803 7th Street NW, 3rd Floor Washington, District of Columbia 20001 Re: K252699 Trade/Device Name: CoAptix S System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: March 10, 2026 Received: March 10, 2026 Dear Dave Mcgurl: 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/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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K252699 - Dave Mcgurl Page 2 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K252699 - Dave Mcgurl Page 3 assistance/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-S Shumaya Ali, M.P.H. 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} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K252699 | | | Device Name CoAptix S System | | | Indications for Use (Describe) The CoAptix S System is intended for the fixation of bone fractures, fusions, osteotomies, reconstructions, non-unions, and malunions in adults. The System is indicated for long bones and long bone fragments, pelvic bones (including the sacrum), and the foot. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | 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} K252699 THE UNIVERSITY OF UTAH # 510(k) Summary Device Trade Name: CoAptix S System Sponsor: University of Utah, Department of Orthopaedics 590 Wakara Way Salt Lake City, UT 84108 Contact: T. Wade Fallin, M.S. Research Professor Phone: (801) 587-2938 Fax: (801) 587-5411 Prepared by: MCRA, LLC Date Prepared: April 3, 2026 Common Name: Smooth or threaded metallic bone fixation fastener; Single/multiple component metallic bone fixation appliances and accessories Classification: 21 CFR 888.3040 (primary); 21 CFR 888.3030 Classification Name: Screw, Fixation, Bone; Washer, Bolt, Nut Class: II Product Code: HWC (primary); HTN ## Indications for Use: The CoAptix S System is intended for the fixation of bone fractures, fusions, osteotomies, reconstructions, non-unions, and malunions in adults. The System is indicated for long bones and long bone fragments, pelvic bones (including the sacrum), and the foot. ## Device Description: The CoAptix S System implants are metallic bone screws, available in multiple lengths, and are intended to be used per the indications for use. The screws are cannulated for use with guidewires for precise placement in bone, the screws are available in headed and headless versions, and an optional washer is available for use with the screws that are headed. ## Predicate Devices: Primary Predicate DePuy Synthes Cortex and Cannulated Screws (K161616) Additional Predicate MedShape DynaFuse Fixation System (K203595) ## Materials: The CoAptix S implants are made from Ti-6Al-4V per ASTM F136 and Nitinol per ASTM F2063. Page 1 of 2 {5} K252699 THE UNIVERSITY OF UTAH ## Performance Data: The CoAptix S System performance was characterized through the following: - Torsional Strength Testing per ASTM F543 - Driving Torque Testing per ASTM F543 - Axial Pull-out Strength Testing per ASTM F543 - Static and Dynamic Bending Testing per ASTM F1264 Annex A4 - Pitting Corrosion per ASTM F2129 - Galvanic Corrosion per ASTM G102 as referenced in ASTM F3044 - Fretting Corrosion - Af Testing per ASTM F2082 No clinical or animal testing was conducted. ## Substantial Equivalence & Conclusions: The CoAptix S System has the same intended use and uses the similar design, materials, principles of operations, and range of sizes as the predicate devices, the DePuy Synthes Cortex and Cannulated Screws (K161616), and MedShape DynaFuse Fixation System (K203595). Side-by-side performance testing demonstrates that the CoAptix S System has equivalent or statistically significantly better performance than its predicates. The CoAptix S System's similarities in technological characteristics to its predicates further support its substantial equivalence. Thus, the CoAptix S System is substantially equivalent to the DePuy Synthes Cortex and Cannulated Screws (K161616) and MedShape DynaFuse Fixation System (K203595). Page 2 of 2 --- **Source:** [https://fda.innolitics.com/device/K252699](https://fda.innolitics.com/device/K252699) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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