← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K092178 # AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS (K092178) _Howmedica Osteonics Corp. · HRS · Nov 20, 2009 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K092178 ## Device Facts - **Applicant:** Howmedica Osteonics Corp. - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Nov 20, 2009 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The AxSOS® SPS Monoaxial Locking Plates in the Stryker Locked Plating system are intended for use in long bone fracture fixation. The AxSOS® SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur. ## Device Story AxSOS® Stryker Locked Plating System line extension adds cable plug styles to existing bone fixation system. Device consists of metallic bone plates and screws used for long bone fracture fixation. Operated by orthopedic surgeons in clinical/surgical settings. Provides mechanical stabilization of fractures. Subject device modifications involve cable plug geometry; functional and mechanical properties remain consistent with predicate systems. ## Clinical Evidence Bench testing only. No clinical data provided. Mechanical and functional testing demonstrated comparable properties to predicate devices. ## Technological Characteristics Metallic bone fixation system (plates and screws) manufactured from Stainless Steel. Designed for long bone fracture fixation. System utilizes monoaxial locking mechanism. No software or electronic components. ## Regulatory Identification Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - [K050512](/device/K050512.md) - [K060514](/device/K060514.md) - [K061012](/device/K061012.md) - [K060798](/device/K060798.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}------------------------------------------------ ## 510(k) Summary of Safety and Effectiveness: AxSOS® Stryker Locked Plating System Line Extension of Cable Plugs ### Submission Information Name and Address of the Sponsor of the 510(k) Submission For Information contact: Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430 NOV 2 0 2009 Melissa A. Matarese, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5116 Fax: (201) 831-4116 Date Summary Prepared: Device Identification Proprietary Name: Common Name: Classification Name and Reference: Device Product Code: July 15, 2009 AxSOS® Stryker Locked Plating System Line Extension of Cable Plugs Bone plates and screws Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3030 87 HRS: Plate, Fixation, Bone 87 HWC: Screw, Fixation, Bone #### Description: This Special 510(k) submission is intended to address modifications to the Stryker Locked Plating System. This line extension is to add additional styles of Cable Plugs. The AxSOS® Cable Plug is being modified as part of a line extension of the Stryker Locked Plating System. The AxSOS® Locked Plating System currently contains 4mm and 5mm Cable Plugs. #### Intended Use: Stryker Locked Plating System Line Extension of Cable Plugs The AxSOS® modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject plates are provided below. #### Indications for Use: The AxSOS® SPS Monoaxial Locking Plates in the Stryker Locked Plating system are intended for use in long bone fracture fixation. The AxSOS® SPS Monoaxial Locking {1}------------------------------------------------ Plates are indicated for fixation of long bone fractures including the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur. # Statement of Technological Comparison: The subject and predicate devices are made from Stainless Steel. Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject AxSOS® Stryker Locked Plating System to the predicate device K050512, K060514, K061012, and K060798. . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002 Howmedica Osteonics Corporation c/o Ms. Melissa Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430 # NOV 20 2009 Re: K092178 Trade/Device Name: AxSOS® Locked Plating System Line Extension of Cable Plugs Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 30, 2009 Received: November 5, 2009 Dear Ms. Matarese: 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 {3}------------------------------------------------ #### Page 2 - Ms. Melissa Matarese CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely yours, Jonetta Jr Image /page/3/Picture/7 description: In this image, there is a close-up of a document with some text. The text includes the name "Mark N. Mel" followed by the title "Director Div". The text also includes the words "and Restora" and "Office of De". Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): Device Name: AxSOS® Locked Plating System Line Extension of Cable Plugs Indications For Use: The AxSOS® SPS Monoaxial Locking Plates in the Stryker Locked Plating system are intended for use in long bone fracture fixation. The AxSOS® SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia, and the distal femur. > Prescription Use X (Part 21 CFR 801 > > Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) AND/OR #### Concurrence of CDRH, Office of Device Evaluation (ODE) Soutte Page 1 of 1 (Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K092178 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K092178](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K092178) **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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