← Product Code [KTW](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTW) · K122541 # ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) (K122541) _Orthofix Srl · KTW · Sep 20, 2012 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTW/K122541 ## Device Facts - **Applicant:** Orthofix Srl - **Product Code:** [KTW](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTW.md) - **Decision Date:** Sep 20, 2012 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The Orthofix Contours Proximal Humeral Plate (PHP) is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. ## Device Story The Orthofix Contours Proximal Humeral Plate (PHP) is a locking titanium bone plate system designed for surgical fixation of proximal humeral fractures, osteotomies, and non-unions. The system comprises left and right-sided plates used with diaphyseal screws, a main locking screw, and fine-threaded titanium screws; titanium or polymeric cerclage wires may provide additional stabilization. The device is intended for use by orthopedic surgeons in a clinical/surgical setting. It functions as a mechanical fixation appliance to stabilize bone fragments, facilitating healing. Modifications from the predicate include dimensional changes to plate width, central height, fixation point diameters, and screw lengths, as well as a transition to a sterile-sold configuration with updated packaging. The device provides mechanical support to bone, particularly beneficial in osteopenic bone, to restore structural integrity. ## Clinical Evidence Bench testing only. Mechanical strength testing was performed in accordance with ASTM F384-06 and ASTM F382-99 to demonstrate equivalence to the predicate device. ## Technological Characteristics Titanium locking bone plate system. Includes diaphyseal screws, main locking screw, and fine-threaded hexagonal screws. Materials are metallic (titanium) with optional polymeric cerclage wires. Mechanical testing conducted per ASTM F384-06 and ASTM F382-99. Sold sterile. ## 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 - Orthofix Titanium Humeral Plating System, "LSP" ([K062920](/device/K062920.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}------------------------------------------------ Page//3 Premarket Notification Orthofix Srl Contours Proximal Humeral Plate (PHP) Image /page/0/Picture/2 description: The image shows the logo for Orthofix. The logo consists of a stylized circular shape above the word "ORTHOFIX". The circular shape is black and white and appears to be an abstract design. The word "ORTHOFIX" is in a bold, sans-serif font. [as required by 21 CFR 807.92(c)] # Orthofix Contours Proximal Humeral Plate (PHP) ## 510(k) K122541 9680825 1. Submitted by: Orthofix Srl Via delle Nazioni 9 37012 Bussolengo (VR) ltaly Registration number Contact Person Elena Varini International Orthopedics Regulatory Manager Telephone: +39 (045) 671 9000 Facsimile: +39 (045) 671 9380 Date Prepared September 17, 2012 #### 2. Device Name: Trade/Proprietary Name Common Name Device Classification Orthofix Contours Proximal Humeral Plate (PHP) Bone plate 87 KTW (21 CFR 888.3030) Single/multiple component metallic bone fixation appliances and accessories. #### 3. Predicate Device: The Orthofix Contours Proximal Humeral Plate (PHP) is substantially equivalent to the Orthofix Titanium Humeral Plating System, "LSP", K062920 ### Intended Use: 4. The Orthofix Contours Proximal Humeral Plate (PHP) is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. {1}------------------------------------------------ K1225411 Page 2/3 Premarket Notification Orthofix Srl Contours Proximal Humeral Plate (PHP) ### 5. Description: This Special 510(k) is being supplied to the U.S. FDA to provide authorization to market the device Orthofix Contours Proximal Humeral Plate (PHP) for interstate commerce. The Orthofix Contours Proximal Humeral Plate (PHP) is a modified version of the Orthofix Titanium Humeral Plating System "LSP", cleared under 510(k) K062920. Like the predicate device, the Orthofix Contours Proximal Humeral Plate (PHP) is a locking titanium plate intended for the treatment of fractures. osteotomies and non-unions of the proximal humerus. The Orthofix Contours Proximal Humeral Plate (PHP) consists of a left and a right plate that has to be used in combination with at least two Diaphyseal Screws, a main locking screw and at least two titanium hexagonal Fine Threaded Screws. In addition titanium/polymeric cerclage wires can be used to achieve further stabilization of the bone fragments. Instrumentation is available for the insertion of the plates and screws. The modifications introduced with the Orthofix Contours Proximal Humeral Plate (PHP) are summarized below: - Dimensional changes, concerning width and central part height of the plate, diameter of some fixation points and lengths of the revision screws. - Sterilization configuration: Orthofix Contours Proximal Humeral Plate (PHP) will be sold in a sterile configuration while the predicate device, Orthofix Titanium Humeral Plating System "LSP" is sold in a non-sterile configuration. - Packaging configuration: as the Orthofix Contours Proximal Humeral Plate (PHP) will be sold in a sterile configuration, the packaging will be modified with respect to the predicate device. #### 6. Substantial equivalence: Documentation is provided which demonstrates the Orthofix Contours Proximal Humeral Plate (PHP) to be substantially equivalent to other legally marketed devices. The Orthofix Contours Proximal Humeral Plate (PHP) and the predicate device Orthofix Titanium Humeral Plating System "LSP" are bone plates as defined in 21 CFR 888.3030, furthermore, the size, shape and materials for the subject devices are comparable to the predicate devices. {2}------------------------------------------------ K122541 Page 3/3. Premarket Notification Orthofix Srl Contours Proximal Humeral Plate (PHP) > Testing in accordance with ASTM F384-06 and ASTM F382-99 shows the mechanical strength of the Orthofix Contours Proximal Humeral Plate (PHP) to be equivalent or better than the predicate devices. ### 7. Conclusion: Based upon the similarities in design, materials and intended uses, it is concluded that the Orthofix Contours Proximal Humeral Plate (PHP) is substantially equivalent to the predicate devices. Orthofix Srl {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Orthofix SRL % Ms. Candace Cederman Consultant 22423 Skyview Drive West Linn. Oregon 97068 Re: K122541 Trade/Device Name: Orthofix Contours Proximal Humeral Plate (PHP) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTW Dated: August 20, 2012 Received: August 21, 2012 Dear Ms. Cederman: 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 SEP 20 2012 {4}------------------------------------------------ ## Page 2 - Ms. Candace Cederman 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 803); 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. 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, Erich Keith Mark N. Melkerson . Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Orthofix Contours Proximal Humeral Plate (PHP) Indications for Use: The Orthofix Contours Proximal Humeral Plate (PHP) is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. Over-The-Counter Use Prescription Use X - AND/OR (Part 21 CFR 801 Subpart D) (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) ASL (Division Sign-Oli) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number k122541 Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTW/K122541](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTW/K122541) **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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