NCB Polyaxial Locking Plate System

K192021 · Zimmer GmbH · HRS · Aug 22, 2019 · Orthopedic

Device Facts

• Record ID: K192021
• Device Name: NCB Polyaxial Locking Plate System
• Applicant: Zimmer GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Aug 22, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.

Device Story

The NCB Polyaxial Locking Plate System is an extramedullary internal fixation system designed for proximal humeral fractures. It consists of metallic bone plates and locking screws. The system is implanted by surgeons using either percutaneous or traditional open surgical methods. The device provides mechanical stabilization of bone fractures and osteotomies to facilitate healing. It is used in clinical settings (OR) by orthopedic surgeons. The system functions as a structural support for bone segments, maintaining alignment during the healing process. It does not involve electronic components, software, or automated analysis.

Clinical Evidence

No clinical data was required or provided for this device. Substantial equivalence was established through non-clinical performance data, including verification of mechanical integrity and resistance.

Technological Characteristics

Metallic bone fixation system. Materials include Tivanium (titanium alloy) for 3.5 mm locking screws. System includes plates and screws for internal fixation. Sterilization methods are standard for orthopedic implants. No software, electronics, or connectivity features.

Indications for Use

Indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones in patients requiring surgical bone fixation.

Regulatory Classification

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.

Predicate Devices

• NCB® Plating System (K042695)
• NCB® Plating System, Proximal Humerus (K081759)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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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# 510(K) SUMMARY

| Sponsor: | Zimmer GmbH<br>Sulzerallee 8, P.O. Box<br>8404 Winterthur, Switzerland |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Danielle Jannuzzi Madureira<br>Senior Specialist, Regulatory Affairs<br>Telephone: [phone]<br>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<br>Screw, Fixation, Bone |
| Regulation Number / Description: | 21 CFR § 888.3030 - Single/multiple component metallic bone<br>fixation appliances and accessories<br>21 CFR § 888.3040 - Smooth or threaded metallic bone fixation<br>fastener. |
| Predicate Device: | NCB® Plating System, manufactured by Zimmer GmbH, K042695,<br>cleared October 29, 2004<br>NCB® Plating System, Proximal Humerus, manufactured by<br>Zimmer GmbH, K081759, cleared October 16, 2008 |
| Device Description: | The NCB Polyaxial Locking Plate System is an extramedullary<br>internal fixation plate system to be used for proximal humeral<br>fractures. It is intended to be implanted either percutaneously or<br>by a traditional open method.<br>The Tivanium 3.5 mm locking screws are used to engage the<br>proximal locking screw holes within the NCB Polyaxial Locking<br>Plate System, Proximal Humeral Plates. |
| Intended Use: | The NCB Polyaxial Locking Plate System is indicated for<br>temporary internal fixation and stabilization of fractures and<br>osteotomies of long bones. |
| Comparison to Predicate Device: | The intended use of the modified devices, as described in its<br>labeling, has not changed as a result of the modifications<br>proposed in the present submission. The line extension does not<br>alter the fundamental scientific technology shared by both the<br>subject devices and predicate devices. The proposed packaging<br>configuration and the methods to support the package integrity<br>have been previously cleared for Zimmer GmbH products. Zimmer<br>GmbH is furthermore seeking clearance for certain system-<br>specific Class II instruments - these instruments that have<br>previously considered Class I exempt and correction of<br>classification to Class II is proposed within present submission. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>Class II: Amendment of Design Controls with verification of<br>mechanical integrity and resistance.<br>Clinical Performance and Conclusions:<br>Clinical data and conclusions were not needed for this device. |
| Conclusion: | The subject devices have the same intended use and similar<br>indications for use as the predicate devices. The subject devices<br>use the same operating principle, incorporate the same basic<br>design and labeling and are manufactured and sterilized using the<br> |

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# 510(K) SUMMARY