(29 days)
Not Found
No
The summary describes a traditional mechanical plating system for fracture fixation and makes no mention of AI or ML.
No
The device is described as an "extramedullary internal fixation plate system" used for "temporary internal fixation and stabilization of fractures and osteotomies of long bones," which aligns with a surgical or orthopedic device rather than a therapeutic device in the sense of delivering therapy (e.g., drug, radiation, electrical stimulation). Its function is to stabilize, not to treat via therapeutic means.
No
The device is a plating system for internal fixation of fractures, which is a therapeutic intervention, not a diagnostic one. It is used to stabilize fractures, 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 hardware implant.
Based on the provided information, 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 details an "extramedullary internal fixation plate system" intended to be "implanted." This further confirms it's a physical device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. IVDs are used for diagnosis, monitoring, or screening based on analyzing biological samples.
Therefore, 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 (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The NCB Plating System is an extramedullary internal fixation plate system to be used for either distal femoral or proximal humeral 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
distal femoral or proximal humeral fractures; long bones
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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OCT 2 9 2004
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey
Manager, Corporate Regulatory Affairs
Telephone: (574) 372-4944
Fax: (574) 372-4605 |
| Date: | September 29, 2004 |
| Trade Name: | NCB® Plating System |
| Common Name: | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Classification Reference: | 21 CFR § 888.3030, 3040 |
| Predicate Devices: | Synthes Anatomical Locking Plate System (aka
LISS), K961413, cleared 8-7-96
DePuy Orthopedics Pe.R.I. II Knee Fracture
System, K003235, cleared 11-06-00
Synthes LCP Proximal Humerus Plate, K011815,
cleared 9-6-01. |
| Device Description: | The NCB Plating System is an extramedullary
internal fixation plate system to be used for either
distal femoral or proximal humeral 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 has the same intended
use, similar performance characteristics, is
manufactured from similar materials and is similar
in design to the predicate devices. |
| Performance Data: | The results of non-clinical (laboratory) performance
testing demonstrate that the device is safe and
effective. |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a head, body, and legs.
OCT 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen H. McKelvey Manager, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581
Re: K042695
Trade/Device Name: NCB® Plating System Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS, HWC Dated: September 29, 2004 Received: September 30, 2004
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.
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 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark H. Millenson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
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 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)
Mark N. Milkusen
for Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number.
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