← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K142776 # Flow-Screw (K142776) _Flow-Fx, LLC · HWC · Mar 23, 2015 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K142776 ## Device Facts - **Applicant:** Flow-Fx, LLC - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Mar 23, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Flow-Screw is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the Flow-Screw can also be used to deliver injectable bone void fillers to a surgical site. ## Device Story Flow-Screw is a cannulated, fenestrated metallic bone fixation screw; used for fracture fixation and bone reconstruction. Device features fenestrations along its length to function as a delivery system for injectable bone void fillers (BVF) to surgical sites. Used in clinical/surgical settings by orthopedic surgeons. Implanted to provide mechanical stabilization of bone fragments; simultaneously enables targeted delivery of bone void fillers to promote healing. Benefits include combined fixation and void filling capability in a single procedure. ## Clinical Evidence Bench testing only. Qualification testing included injectability testing, experimental void fill imaging studies, static extraction torque, and BVF characterization using ETEX Beta-bsm and CarriGen. Mechanical testing demonstrated substantial equivalence to predicates under static compression and bending loads. ## Technological Characteristics Cannulated, fenestrated screw design. Materials: Titanium alloy (ASTM F136) or stainless steel (ASTM F138 or ASTM F2229). Available in fully and partially threaded configurations. Mechanical fixation via threaded engagement; BVF delivery via fenestrations. ## 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 - Synthes Cannulated Screws ([K962823](/device/K962823.md)) - Synthes Cannulated Screws ([K962011](/device/K962011.md)) - N-Force Fixation System ([K102528](/device/K102528.md)) - N-Force Fixation System ([K132244](/device/K132244.md)) ## Reference Devices - ETEX Beta-bsm ([K062630](/device/K062630.md)) - ETEX Beta-bsm ([K072355](/device/K072355.md)) - ETEX CarriGen ([K090242](/device/K090242.md)) - ETEX CarriGen ([K101557](/device/K101557.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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting community and connection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 23, 2015 Flow-FX, LLC % Ms. Michelle McDonough Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street NW, 12th Floor Washington, DC 20005 Re: K142776 Trade/Device Name: Flow-Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 12, 2015 Received: February 13, 2015 Dear Ms. McDonough: 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. 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); good manufacturing practice requirements as set {1}------------------------------------------------ Page 2 - Ms. Michelle McDonough forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. # Lori A. Wiggins -S 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): K142776 Device Name: Flow-Screw The Flow-Screw is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the Flow-Screw can also be used to deliver injectable bone void fillers to a surgical site. V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ # 510(k) Summary | Device Trade Name: | Flow-Screw | |--------------------|-----------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | Flow-FX, LLC
19110 Darvin Drive
Mokena, Illinois 60448
815.531.4424 | | Prepared by: | Musculoskeletal Clinical & Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
202.552.5800 | | Date Prepared: | February 12, 2015 | | Common Name: | Bone Fixation Screw | | Classification: | 21 CFR 888.3040, Smooth or threaded metallic bone fixation fastener | | Class: | II | | Product Code: | HWC | ## Indications For Use: The Flow-Screw is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the Flow-Screw can also be used to deliver injectable bone void fillers to a surgical site. ## Device Description: The Flow-Screw is cannulated and available in fully and partially threaded designs in various lengths. The Flow-Screw is fenestrated along its length which allows it to be used as a delivery system for injectable bone void fillers. The Flow-Screw implants are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or stainless steel conforming to ASTM F138 or ASTM F2229. ## Predicate Devices: The Flow-Screw was shown to be substantially equivalent to the Synthes Cannulated Screws (K962823 and K962011) and the N-Force Fixation System (K102528 and K132244). ## Substantial Equivalence: The table below summarizes the substantial equivalence of the Flow-Screw to predicate devices with respect to its intended use, design, materials, available sizes, mechanical performance, and ability to deliver BVF to a defect site. {4}------------------------------------------------ | | Subject Device | Predicate Devices | | | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | | Flow-Screw | Synthes | InnoVision N-Force
Fixation System | | | | | | | | | | N/A | K962011
K962823 | K102528
K132244 | | | Intended Use | Intended for temporary fracture fixation and stabilization of the bone. | | | | | Indications for Use | The Flow-Screw is
intended for the
fixation of bone
fractures and bone
reconstructions.
When used for
these indications,
the Flow-Screw can
also be used to
deliver injectable
bone void fillers to
a surgical site. | The Synthes 3.0mm
Cannulated Screw is
intended for fractures
of carpals and
metacarpals, carpal
and metacarpal
arthrodesis; small
fragments of the hand
and wrist, and certain
metatarsal-phalangeal
applications (in foot).
Synthes 7.0/7.3mm
Cannulated Screws
are generally
intended for fracture
fixation of large
bones and large bone
fragments. | The N-Force Fixation
System is intended
for the fixation of
bone fractures and
bone reconstructions.
When used for these
indications, the N-
Force Fixation
System can also be
used to deliver the
following bone void
fillers to a surgical
site:
• Beta-bsm (ETEX)
• CarriGen (ETEX) | | | | Components | Screws | Screws | Screws | | | Materials | Titanium Alloy | Titanium Alloy | Titanium Alloy | | | | Stainless Steel | Stainless Steel | | | | Screw Sizes | Within predicate
range | A range of sizes to | A range of sizes to | | | | | accommodate various | accommodate various | | | | | patient anatomies | patient anatomies | | | Mechanical
Performance | Mechanical testing demonstrates the substantial equivalence of the
Flow-Screw relative to the identified predicates when subjected to
static compression bending loads. | | | | | BVF Delivery | Yes | No | Yes | | | BVF Delivery
System | The qualification testing (i.e., Injectability Testing, Experimental Void
Fill Imaging Studies, Static Extraction Torque, BVF Characterization)
was performed with ETEX Beta-bsm and CarriGen (K062630,
K072355, K090242, K101557) | | | --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K142776](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K142776) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com