← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K113718 # NCB STRAIGHT NARROW SHAFT PLATES (K113718) _Zimmer GmbH · HRS · Jan 27, 2012 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K113718 ## Device Facts - **Applicant:** Zimmer GmbH - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Jan 27, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The NCB Straight Narrow Shaft Plate is indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including: Periprosthetic fractures Comminuted fractures Fractures in osteopenic bone Nonunions Malunions ## Device Story The NCB Straight Narrow Shaft Plate is a polyaxial locking plate system designed for orthopedic trauma surgery. It facilitates internal fixation of humeral and tibial fractures. The system utilizes titanium alloy plates, screws, blind screw inserts, spacers, and locking caps. A key feature is the Non-Contact-Bridging (NCB) concept, which allows the plate to act as an internal fixator without direct contact with the bone surface, thereby preserving periosteal blood supply. Surgeons can control this gap using 1, 2, or 3mm spacers inserted into plate holes. The system supports polyaxial screw placement within a 30° cone, with locking achieved by threading locking caps into the plate holes. The device is intended for use by orthopedic surgeons in clinical settings to stabilize fractures, potentially improving healing outcomes in complex cases like osteopenic bone or periprosthetic fractures. ## Clinical Evidence No clinical data was required or provided for this device. Substantial equivalence was established through non-clinical bench testing, including comparative fatigue testing, plate stiffness analysis (bending and torsion), and construct strength testing. A literature review was conducted to support use in osteopenic bone. ## Technological Characteristics Polyaxial locking plate system; titanium alloy construction; 30° polyaxial screw cone; locking caps for screw fixation; Non-Contact-Bridging (NCB) technology using 1, 2, or 3mm spacers; mechanical fixation via bone screws and plates. ## 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 - 4.5mm Locking Compression Plate (LCP) System ([K082807](/device/K082807.md)) - NCB Periprosthetic Femur Polyaxial Locking Plate System ([K100111](/device/K100111.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}------------------------------------------------ K113718 #1/2 Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a circle with the letter Z inside of it. Below the circle is the word "zimmer" in a stylized font. JAN 2 7 20:12 P.O. Box 708 Warsaw. IN 46581-0708 574 267-6131 ### 510(k) Summary Zimmer. GmbH SulzerAllee 8 Sponsor: Contact Person: Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 371-8760 December 16, 2011 NCB® Straight Narrow Shaft Plates Winterthur, Switzerland CH-8404 Locking Plate System Plate, Fixation, Bone (21 CFR 888.3030) 4.5mm Locking Compression Plate (LCP) System with Expanded Indications, manufactured by Synthes, K082807, cleared January 13, 2009, and NCB Periprosthetic Femur Polyaxial Locking Plate System, manufactured by Zimmer, K100111, cleared April 12, 2010. The NCB Straight Narrow Shaft Plates are a line of polyaxial locking plates for the treatment of humeral and tibial shaft fractures, including periprosthetic fractures. The NCB System technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the plate holes. In the locked mode the NCB Straight Narrow Shaft Plate acts as an internal fixator without contact between the plate and the bone surface, reducing the risk of periosteal blood supply impairment. This Non-Contact-Bridging concept can be specifically controlled through the use of 1, 2, or 3mm spacers, which are threaded into the plate holes prior to plate insertion. Plates, screws, blind screw inserts, spacers and locking caps are made of titanium alloy. Date: Trade Name: Common Name: Classification Names and References: Predicate Devices: Device Description: {1}------------------------------------------------ K11378 #212 | Intended Use: | The NCB Straight Narrow Shaft Plate is indicated for
temporary internal fixation and stabilization of humeral and
tibial fractures and osteotomies, including: | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Periprosthetic fractures Comminuted fractures Fractures in osteopenic bone Nonunions Malunions | | Comparison to Predicate Device: | The NCB Straight Narrow Shaft Plates are similar in
intended use, materials, sterility, and performance
characteristics to the predicate devices. | | Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions: | | | The results of non-clinical (lab) performance testing
demonstrate that the devices are safe and effective and
substantially equivalent to the predicate devices. | | | Engineering analysis as well as results of comparative
fatigue testing of the NCB Straight Narrow Shaft Plate and
Synthes 4.5 mm Locking Compression Plates (predicate
devices) resulted in very similar mechanical properties of
both devices. | | | Plate testing/analyses performed included; plate stiffness
(bending and torsion), plate fatigue strength, screw/plate
construct strength, construct strength with the compatible
cables and Cable Button and compression slot resistance to
screw pull-through. | | | A literature review was conducted to substantiate the use of
the proposed device in osteopenic bone. | | | Clinical Performance and Conclusions: | | | Clinical data and conclusions were not needed for this
device. | **Intended** The *NCB* Straight Narrow Shaft Plate is indicated for temporary internal fixation and stabilization of humeral and tibial fractures and osteotomies, including: {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Zimmer GMBH % Mr. Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581 JAN 2-7 2012 Re: K113718 Trade/Device Name: NCB® Straight Narrow Shaft Plates 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: December 16, 2011 Received: December 19, 2011 Dear Mr. McKelvey: 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {3}------------------------------------------------ ## Page 2 -- Mr. Stephen H. McKelvey 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, ely yours, N. Melkerson Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use ### KI13718 510(k) Number (if known): Device Name: NCB® Straight Narrow Shaft Plate #### Indications for Use: The NCB Straight Narrow Shaft Plate is indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including: - · Periprosthetic fractures - · Comminuted fractures - · Fractures in osteopenic bone - Nonunions - Malunions Prescription Use X (Part 21 CFR 801 Subpart D) ### AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Ja. N. Shup (Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices 510(k) Number K113718 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K113718](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K113718) **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