(24 days)
Not Found
No
The description focuses on mechanical fixation and does not mention any software, algorithms, or data processing that would suggest AI/ML.
No
The device is described as an "extramedullary internal fixation plate system" for fractures, which is a structural support device rather than one that treats a disease or condition therapeutically.
No
The provided text describes a medical device used for internal fixation of fractures (a treatment), not for the identification or analysis of medical conditions (diagnosis).
No
The device description clearly describes a physical implantable plate system and associated screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "temporary internal fixation of fractures and osteotomies of long bones." This describes a surgical implant used to stabilize bones within the body.
- Device Description: The description details a "extramedullary internal fixation plate system" and "locking screws" used for "proximal humeral fractures." This further confirms it's a physical implant for surgical use.
- 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. This device does not perform any such tests.
The information provided describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation of fractures and osteotomies of long bones.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The NCB Polyaxial Locking Plate System is an extramedullary internal fixation plate system to be used for proximal humeral fractures. It is intended to be implanted either percutaneously or by a traditional open method. The Tivanium 3.5 mm locking screws are used to engage the proximal locking screw holes within the NCB Polyaxial Locking Plate System, Proximal Humeral Plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non-Clinical Performance and Conclusions: Class II: Amendment of Design Controls with verification of mechanical integrity and resistance.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
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.
0
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Zimmer GmbH Danielle Madureira Senior Specialist, Regulatory Affairs Sulzerallee 8 Winterthur, 8404 CH
Re: K192021
Trade/Device Name: NCB Polyaxial Locking Plate System 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: July 25, 2019 Received: July 29, 2019
Dear Danielle Madureira:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali. MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192021
Device Name
NCB® Polyaxial Locking Plate System, Proximal Humerus
Indications for Use (Describe)
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation of fractures and osteotomies of long bones.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(K) SUMMARY
| Sponsor: | Zimmer GmbH
Sulzerallee 8, P.O. Box
8404 Winterthur, Switzerland |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Danielle Jannuzzi Madureira
Senior Specialist, Regulatory Affairs
Telephone: +41 58 854 82 60
Fax: + 41 52 244 86 58 |
| Date: | July 25, 2019 |
| Trade Name: | NCB® Plating System, Proximal Humerus |
| Classification Product Code : | HRS, HWC |
| Device Classification Name: | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Regulation Number / Description: | 21 CFR § 888.3030 - Single/multiple component metallic bone
fixation appliances and accessories
21 CFR § 888.3040 - Smooth or threaded metallic bone fixation
fastener. |
| Predicate Device: | NCB® Plating System, manufactured by Zimmer GmbH, K042695,
cleared October 29, 2004
NCB® Plating System, Proximal Humerus, manufactured by
Zimmer GmbH, K081759, cleared October 16, 2008 |
| Device Description: | The NCB Polyaxial Locking Plate System is an extramedullary
internal fixation plate system to be used for proximal humeral
fractures. It is intended to be implanted either percutaneously or
by a traditional open method.
The Tivanium 3.5 mm locking screws are used to engage the
proximal locking screw holes within the NCB Polyaxial Locking
Plate System, Proximal Humeral Plates. |
| Intended Use: | The NCB Polyaxial Locking Plate System is indicated for
temporary internal fixation and stabilization of fractures and
osteotomies of long bones. |
| Comparison to Predicate Device: | The intended use of the modified devices, as described in its
labeling, has not changed as a result of the modifications
proposed in the present submission. The line extension does not
alter the fundamental scientific technology shared by both the
subject devices and predicate devices. The proposed packaging
configuration and the methods to support the package integrity
have been previously cleared for Zimmer GmbH products. Zimmer
GmbH is furthermore seeking clearance for certain system-
specific Class II instruments - these instruments that have
previously considered Class I exempt and correction of
classification to Class II is proposed within present submission. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Class II: Amendment of Design Controls with verification of
mechanical integrity and resistance.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device. |
| Conclusion: | The subject devices have the same intended use and similar
indications for use as the predicate devices. The subject devices
use the same operating principle, incorporate the same basic
design and labeling and are manufactured and sterilized using the
|
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