(29 days)
Not Found
No
The summary describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a plating system indicated for temporary internal fixation of fractures and osteotomies, which is a therapeutic purpose.
No
The device description and intended use clearly state that it is a plating system for internal fixation of fractures, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is an "extramedullary internal fixation plate system," which is a physical hardware implant.
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 further clarifies it as an "extramedullary internal fixation plate system" intended to be "implanted." This confirms its function as a physical device placed inside the patient.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The NCB Plating 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 Plating System is an extramedullary internal fixation plate system to be used for either distal femoral or 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
distal femoral or proximal tibia 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
September 13, 2019
Zimmer GmbH Tiana Steinhoff Regulatory Affairs Specialist Sulzerallee 8 Winterthur, 8404 CH
Re: K192217
Trade/Device Name: NCB Plating System Distal Femur and Proximal Tibia 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: August 12, 2019 Received: August 15, 2019
Dear Tiana Steinhoff:
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
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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
NCB® Plating System, Distal Femur and Proximal Tibia
Indications for Use (Describe)
The NCB Plating 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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Image /page/3/Picture/2 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a white "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. Below the company name is the tagline "Your progress. Our promise".
510(k) SUMMARY
| Sponsor: | Zimmer GmbH
Sulzerallee 8, P.O. Box
8404 Winterthur, Switzerland |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiana Steinhoff
Specialist, Regulatory Affairs
Telephone: +41 58 854 82 96
Fax: +41 52 244 86 58 |
| Date: | August 12th, 2019 |
| Trade Name: | NCB® Plating System, Distal Femur and its line extension
Proximal Tibia |
| Classification Product Code : | Plate System
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, Distal Femur, manufactured by Zimmer
GmbH, K042695, cleared in October 2004 (primary predicate)
NCB® Plating System, Proximal Tibia, manufactured by Zimmer
GmbH, K061211, cleared in June 2006 (line extension of
K042695) |
| Device Description: | The NCB Plating System is an extramedullary internal fixation
plate system to be used for either distal femoral or 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 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 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 same
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
same materials and processes as the predicate devices.
Except for the modifications described in this submission the
subject devices are identical to the predicate devices, and the
performance data and analyses demonstrate that:
any differences do not raise new questions of safety and
effectiveness as established with performance testing; and the subject devices are at least as safe and effective as
the legally marketed predicate devices. |
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510(K) SUMMARY
Image /page/4/Picture/2 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. Below the company name is the tagline "Your progress. Our promise." in a smaller font.