← Product Code [HWC](/productcode/HWC) · K260106 # OsteoCoil™ GT Active Compression System (K260106) _Flower Orthopedics Corporation DBA Conventus Flower Orthoped · HWC · Aug 24, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260106 ## Device Facts - **Applicant:** Flower Orthopedics Corporation DBA Conventus Flower Orthoped - **Product Code:** [HWC](/productcode/HWC.md) - **Decision Date:** Aug 24, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The OsteoCoil™ GT Active Compression System is intended for use in bone fragment stabilization and boney fusion. ## Device Story Cannulated, Nitinol-based dynamic compression screw system; used for bone fragment stabilization and fusion in small bones (wrist, hand, foot). Device consists of a cannulated rod with a distal threaded region and a proximal head; features a helical cut/dynamic compression element allowing axial elongation to maintain compression during bone resorption. Includes a torque-bearing mechanism at the distal interface of the sleeve and internal rod to isolate the compression element from torsional loads during insertion. Operated by healthcare professionals in hospital settings; inserted over a guidewire. Provides continuous compression across bony fusion sites despite bone remodeling; benefits patient by maintaining stability during healing. Implants provided sterile (single-use); instruments provided non-sterile for reprocessing. ## Clinical Evidence No clinical data included. Bench testing and Finite Element Analysis were used to confirm performance. Biocompatibility, sterility, and shelf-life processes are identical to the predicate device (K233567). ## Technological Characteristics Material: Nitinol (ASTM). Principle: Dynamic compression via helical cut shaft with integrated torque-bearing mechanism. Form factor: Cannulated screw. Energy: None (mechanical). Sterilization: Gamma irradiation (SAL 10^-6). Shelf-life: 7 years. Connectivity: None. ## 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 - OsteoCoil™ Nitinol Compression System ([K233567](/device/K233567.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 August 24, 2026 Flower Orthopedics Corporation DBA Conventus Flower Orthopedics % Jessica Czamanski Regulatory, Quality, and Compliance Consultant DuVal & Associates, P.A. 825 Nicollet Mall, Suite 1820 Medical Arts Bldg. Minneapolis, Minnesota 55402 Re: K260106 Trade/Device Name: OsteoCoil™ GT Active Compression System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 12, 2026 Received: January 14, 2026 Dear Jessica Czamanski: 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} K260106 - Jessica Czamanski 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} K260106 - Jessica Czamanski 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} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260106 | ? | | Please provide the device trade name(s). | | ? | | OsteoCoil™ GT Active Compression System | | | | Please provide your Indications for Use below. | | ? | | The OsteoCoil™ GT Active Compression System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, & fracture fixation of the small bones for wrist, hand, and foot. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} conventus FLOWER ORTHOPEDICS Traditional 510(k) OsteoCoil™ GT Active Compression System K260106 # K260106 510(K) SUMMARY # I. Submitter Submitter's Name: Flower Orthopedics Corporation DBA Conventus Flower Orthopedics Contact Person: Kevin Rzasa Address: 100 Witmer Road Suite 280, Horsham, PA, 19044 Telephone: 610-202-1342 Email: kevin.rzasa@flowerortho.com Date prepared: August 19, 2026 # II. Applicant Correspondent Contact's Name: DuVal & Associates, P.A. Contact Person: Jessica Czamanski Telephone: 754-422-9101 Email: jczamanski@duvalfdalaw.com # III. Device Trade Name: OsteoCoil™ GT Active Compression System Common Name: Screw, Bone, Fixation Classification Name: Smooth or threaded metallic bone fixation fastener Product Classification: Class II Regulation Number: 21 CFR § 888.3040 Product Code: HWC # IV. Predicate Device Manufacturer: Conventus Flower Orthopedics Conventus Flower Orthopedics Page 1 {5} conventus FLOWER ORTHOPEDICS Traditional 510(k) OsteoCoil™ GT Active Compression System K260106 Device Name: OsteoCoil™ Nitinol Compression System 510(k) Number: K233567 Product Classification: Class II Regulation Number: 21 CFR § 888.3040 # V. Device Description The proposed device is comprised of dynamic compression screw and required accessories, intended to provide adequate initial compression and adequate compression over an extended period of time when used in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones. For example, if there is bone resorption, then the product will axially contract for continued compression. The OsteoCoil GT implants are comprised of an implantable, cannulated rod with a threaded region at the distal end. The unthreaded portion of the rod contains a helical cut or dynamic compression feature which allows axial elongation. A thin-walled tube with a head at the proximal end is seated around the cannulated rod and attached at the head end. There is a torque bearing mechanism at the distal interface of the sleeve and internal rod, which allows torque to be transmitted without loading the compression element. The cannulation allows for insertion over a guidewire. The head engages with a proximal end of a first bone segment, and the threaded region engages with a second bone segment. The head also includes a drive feature for insertion. The system is comprised of sterile implants for single use only. Instruments are provided non-sterile and may be reprocessed. # VI. Intended Use The OsteoCoil™ GT Active Compression System is intended for use in bone fragment stabilization and boney fusion. Conventus Flower Orthopedics Page 2 {6} conventus FLOWER ORTHOPEDICS Traditional 510(k) OsteoCoil™ GT Active Compression System K260106 # VII. Indications for Use The OsteoCoil™ GT Active Compression System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, & fracture fixation of small bones for wrist, hand, and foot. # VIII. Comparison of Technological Characteristics with Predicate Device The Subject and Predicate devices in this submission are almost identical, with differences limited to minor design characteristics. Table 1: General Technological Characteristics Comparison | Product Features | Subject Device Conventus' OsteoCoil™ GT Active Compression System (K260106) | Predicate Device Conventus' OsteoCoil™ Nitinol Compression System (K233567) | | --- | --- | --- | | Classification | Class II | SAME | | Product Code | HWC | SAME | | Regulation Number | §888.3040 | SAME | | Regulation Name | Smooth or threaded metallic bone fixation fastener | SAME | | Intended Use | The OsteoCoil™ GT Active Compression System is intended for use in bone fragment stabilization and boney fusion. | SAME | | Indications for Use | The OsteoCoil™ GT Active Compression System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, & fracture | SAME | Conventus Flower Orthopedics Page 3 {7} conventus FLOWER ORTHOPEDICS Traditional 510(k) OsteoCoil™ GT Active Compression System K260106 Table 1: General Technological Characteristics Comparison | Product Features | Subject Device Conventus' OsteoCoil™ GT Active Compression System (K260106) | Predicate Device Conventus' OsteoCoil™ Nitinol Compression System (K233567) | | --- | --- | --- | | | fixation for small bones for wrist, hand, and foot. | | | **Materials** | Nitinol ASTM | SAME | | **Environment of Use** | Hospital | SAME | | **Provided Sterile** | Implants – Yes Instruments – No | SAME | | **Principle of Operation** | The OsteoCoil™ GT Active Compression System supports the fracture site in the same way traditional bone screws do while taking advantage of the patient anatomy and bone healing occurring at the injury site. The proprietary compressive technology of the implant causes an opposing compression force between the implant head and threads. Typically, a bone screw provides an initial compression force which is lost as soon as there is bone length loss due to bone remodeling. The unique OsteoCoil implant results in a compression force applied across a bony fusion site even with loss of length throughout | The principle of operation is the same, except that the OsteoCoil Nitinol Compression System does not have the torque bearing mechanism in the Subject Device. Therefore, the transmission of torque is less efficient. | Conventus Flower Orthopedics Page 4 {8} [LOGO] Conventus FLOWER ORTHOPEDICS Traditional 510(k) OsteoCoil™ GT Active Compression System K260106 Table 1: General Technological Characteristics Comparison | Product Features | Subject Device Conventus' OsteoCoil™ GT Active Compression System (K260106) | Predicate Device Conventus' OsteoCoil™ Nitinol Compression System (K233567) | | --- | --- | --- | | | bone resorption. The OsteoCoil GT system adds a torque bearing mechanism to the implant shaft, which is distal to the helical shaft and reduces the torsional load on the helical compression feature. | | | User Profile | Healthcare Professional Only | SAME | | Single Use | Implants – Yes Instruments – No | SAME | | Sterilization | Gamma Irradiation | SAME | | SAL | 10^{-6} | SAME | | Shelf-Life | 7 years | SAME | Conventus Flower Orthopedics Page 5 {9} conventus FLOWER ORTHOPEDICS Traditional 510(k) OsteoCoil™ GT Active Compression System K260106 # IX. Performance Data # Bench Testing No additional bench performance testing is included to support this Traditional 510(k). The OsteoCoil™ GT Active Compression System and its Predicate Device are significantly similar in design, materials, and manufacturing, and Finite Element Analysis was performed to further confirm expected performance of the device. # Reprocessing, Sterility, and Shelf-Life No additional reprocessing, sterility, and shelf-life testing is required as processes are identical to those in K233567. Routine pyrogen testing will be conducted on representative samples from each product lot. # Biocompatibility No additional biocompatibility testing is required as manufacturing materials and processes are identical to those in K233567. # Electrical Safety and Electromagnetic Compatibility (EMC) There are no electrical components in the proposed device. All components are components of Nitinol and have not been evaluated for electromagnetic compatibility. # Performance Testing – Animal This submission does not include animal testing. # Performance Testing – Clinical This submission does not include clinical testing. # X. Conclusion Base on the data and justifications presented in this submission, The OsteoCoil™ GT Active Compression System is considered substantial equivalent to the OsteoCoil Nitinol Compression System. Conventus Flower Orthopedics Page 6 --- **Source:** [https://fda.innolitics.com/device/K260106](https://fda.innolitics.com/device/K260106) **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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