← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K014185 # AOS CANNULATED BONE SCREW SYSTEM (K014185) _Advanced Orthopaedic Solutions, Inc. · HWC · Feb 13, 2002 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K014185 ## Device Facts - **Applicant:** Advanced Orthopaedic Solutions, Inc. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Feb 13, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The AOS Cannulated Bone Screw System is intended for fracture fixation of small and long bones and of the pelvis. This system is not intended for spinal use. ## Device Story AOS Cannulated Bone Screw System consists of titanium alloy self-drilling, self-tapping cannulated screws (4.0mm, 5.0mm diameters; 10mm-150mm lengths) and associated washers. Screws are partial or fully threaded. Device used by surgeons for fracture fixation of small/long bones and pelvis. System is non-sterile. Provides mechanical stabilization of bone fractures. Not for spinal applications. ## Clinical Evidence Bench testing only. ## Technological Characteristics Titanium alloy cannulated screws; self-drilling and self-tapping design; diameters 4.0mm and 5.0mm; lengths 10mm to 150mm; partial or full threading; includes washers; non-sterile. ## 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 - Howmedica Osteonics ASNIS III Cannulated Screw System - Smith and Nephew 5.5mm and 7.0mm Titanium and Stainless Steel Cannulated Screws - Smith and Nephew 6.5mm and 4.0mm Cannulated Screws ## 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}------------------------------------------------ K014185 1// #### 510(k) SUMMARY NAME OF FIRM: 510(k) CONTACT PERSON: TRADE NAME: COMMON NAME: CLASSIFICATION: Advanced Orthopaedic Solutions FEB 1 3 2002 Paul Doner Vice President Operations and Regulatory AOS Cannulated Bone Screw System Bone Fixation Screws and Washers 888.3040 Smooth or Threaded Metallic Bone Fixation Fastener 888.3030 Single/Multiple Bone Fixation Appliance and Accessories DEVICE CODE: ## SUBSTANTIALLY EQUIVALENT DEVICES: HWC and HTN Smith and Nephew - 5.5mm and 7.0mm Titanium and Stainless Steel Cannulated Screws Smith and Nephew - 6.5mm and 4.0mm Cannulated Screws Howmedica Osteonics - ASNIS III Cannulated Screw System #### INTENDED USE: The AOS Cannulated Bone Screw System is intended for fracture fixation of small and long bones and of the pelvis. This system is not intended for spinal use. ### DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES: The AOS Cannulated Bone Screw System consists of titanium alloy self-drilling, self-tapping cannulated screws in diameters of 4.0mm, 5.0mm and in lengths ranging from 10mm to 150mm. The screws are either partial threaded or fully threaded. There are two washers in the system, one for use with the 4.0mm and 5.0mm screws and one for use with the 7.0mm screws. All screw are packaged and sold as non-sterile. The AOS Cannulated Bone Screw System is substantially equivalent to the following marketed devices: Howmedica Osteonics, ASNIS III Cannulated Screw System, 4.0mm, 5.0mm, 6.5mm and 8.0mm; Smith and Nephew, 5.0mm and 7.0mm Titanium and Stainless Steel Cannulated Screws; and the Smith and Nephew, 6.5mm and 4.0mm Cannulated Screws. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # FEB 1 3 2002 Mr. Paul Doner Vice President, Operations and Regulatory Advanced Orthopaedic Solutions (AOS) 333 W. 6th Street, Suite 202 San Pedro, California 90731 Re: K014185 Trade/Device Name: AOS Cannulated Bone Screw System Regulatory Number: 888.3040 and 888.3030 Regulation Name: Smooth or Threaded Metallic bone Fixation Fastener and Single/Multiple bone Fixation Appliance and Accessories Regulatory Class: II Product Code: HWC and HTN Dated: December 18, 2001 Received: December 20, 2001 Dear Mr. Doner: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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. {2}------------------------------------------------ Page 2 - Mr. Paul Doner This letter will allow you to begin marketing your device as described in your Section 510(k) The Children Children Calling of a line of sourcelerse of your device to a legal This letter will allow you to begil marks.mig your antine equivalence of your device to a legally premarket notification. The FDA finding of substantial equivale end this p premarket notification. The FDA inding of substantial equively and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your do viteo diagnostic devices), please contact the Office of additionally 21 CFR Part 809.10 for in vites diagnostic devices), please con additionally 21 CFR Part 809.10 III viato units and the promotion and advertising of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertisi Compliance at (301) 394-4639. Additionally, for questis of 904-4639. Also, please note the your device, please comact the Orited of centraliation" (21CFR Part 807.97). regulation entitled, "Misbranding by reference to premarket at may be obtained from the regulation entitled, "Misoranding by reference to proder the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number Division of Dinar (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Muriam C. Provost for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K=14185 510(k) Number (if known) AOS Cannulated Bone Screw System Device Name: Indications for Use: The AOS Cannulated Bone Screw System is intended for fracture fixation of small and long bones and of the pelvis. This system is not intended for spinal use. Concurrence of CDRH, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter _____________________________________________________________________________________________________________________________________________________________ Muriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K014185 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K014185](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K014185) **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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