(44 days)
Not Found
No
The summary describes a traditional mechanical implant (plating system) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is used for internal fixation and stabilization of fractures and osteotomies, which is a supportive and restorative function rather than a therapeutic one (e.g., delivering medication, treating disease).
No
Explanation: The device is a plating system for internal fixation and stabilization of fractures and osteotomies, which is a therapeutic function, not diagnostic. Its purpose is to treat, not to identify or characterize a disease or condition.
No
The device description clearly states it is an "extramedullary internal fixation plate system," which is a physical implantable hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "temporary internal fixation and stabilization of fractures and osteotomies of long bones." This describes a surgical implant used to treat a physical condition within the body.
- Device Description: The description further clarifies it's an "extramedullary internal fixation plate system" intended to be "implanted." This confirms its role as a physical device used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or analysis of biological markers.
Therefore, based on the provided information, the NCB Plating System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NCB Plating System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.
Product codes
HRS, HWC
Device Description
The NCB Plating System is an extramedullary internal fixation plate system to be used for proximal tibia fractures. It is intended to be implanted either percutaneously or by a traditional open method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones (specifically proximal tibia fractures mentioned in device description)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a stylized letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The text is in a bold, sans-serif font.
Kobizil
Summary of Safety and Effectiveness
JUN 1 4 2006
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anthony Francalancia
Senior Associate, Regulatory Affairs
Telephone: (574) 372-4570
Fax: (574) 372-4605 |
| Date: | April 28, 2006 |
| Trade Name: | NCB® Plating System |
| Common Name: | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Classification Reference: | 21 CFR § 888.3030, 3040 |
| Predicate Devices: | Zimmer NCB® Plating System, Humerus and
Femur Plates (K042695, cleared October 29, 2004).
Synthes 4.5mm Titanium LCP Proximal Tibia
Plating System (K023802, cleared January 28.
2003).
Synthes 3.5mm Titanium LCP Proximal Tibia
Plating System (K030597, cleared March 20, 2003). |
| Device Description: | The NCB Plating System is an extramedullary
internal fixation plate system to be used for
proximal tibia fractures. It is intended to be
implanted either percutaneously or by a traditional
open method. |
| Intended Use: | The NCB Plating System is indicated for temporary
internal fixation and stabilization of fractures and
osteotomies of long bones. |
| Comparison to Predicate Device: | The NCB Plating System Proximal Tibia plates
have the same intended use, similar performance
characteristics, are made of the same material and
are similar in design to the predicate devices. |
1
Image /page/1/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a circle with a stylized letter "Z" inside of it. To the right of the circle is the word "zimmer" in lowercase letters. The font is bold and sans-serif.
Performance Data (Non-clinical):
The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
,
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer, GmbH % Mr. Anthony Francalancia Senior Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
APR 1 3 2012
Re: K061211 Trade/Device Name: NCB® Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: April 28, 2006 Received: May 1. 2006
Dear Mr. Francalancia:
This letter corrects our substantially equivalent letter of June 14, 2006.
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 (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 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 - Mr. Anthony Francalancia
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 vours.
Mark A. Wilkerson
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
510(k) Number (if known): KXQ | 2 | |
Device Name:
NCB® Plating System
Indications for Use:
The NCB Plating System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.
Prescription Use _X (Part 2) 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)
D. O'Dell
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K061211
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