(39 days)
Not Found
No
The description focuses on the mechanical properties and design of a bone plate system, with no mention of AI or ML.
Yes
The device is a medical plate used for temporary internal fixation and stabilization of fractures, which falls under the definition of a therapeutic device.
No
Explanation: The device is described as an internal fixator for stabilizing fractures and osteotomies, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly details physical components made of titanium alloy (plates, screws, blind screw inserts, spacers, locking caps) and describes mechanical properties and testing, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant (a plate and screws) used for the internal fixation and stabilization of bone fractures. This device is physically implanted into the body.
- Intended Use: The intended use is to fix and stabilize bone fractures and osteotomies. This is a direct treatment of a physical condition within the body, not an analysis of a specimen taken from the body.
The description clearly indicates a device used in vivo (within the living body) for structural support, not in vitro (in glass, referring to laboratory testing of specimens).
N/A
Intended Use / Indications for 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
Product codes
HRS, HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humeral and tibial shaft
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
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