NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES

K061211 · Zimmer GmbH · HRS · Jun 14, 2006 · Orthopedic

Device Facts

• Record ID: K061211
• Device Name: NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
• Applicant: Zimmer GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Jun 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

NCB Plating System is an extramedullary internal fixation system for long bone fractures and osteotomies. Device consists of bone plates and screws; implanted via percutaneous or traditional open surgical methods. Used by orthopedic surgeons in clinical settings to stabilize bone segments during healing. System provides mechanical support to bone; facilitates fracture reduction and fixation. Benefits include stabilization of bone fragments to promote union. No software or algorithmic components involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Extramedullary internal fixation system comprising metallic bone plates and screws. Designed for proximal tibia fractures. Mechanical fixation device; no energy source, software, or electronic components.

Indications for Use

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

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

• Zimmer NCB® Plating System, Humerus and Femur Plates (K042695)
• Synthes 4.5mm Titanium LCP Proximal Tibia Plating System (K023802)
• Synthes 3.5mm Titanium LCP Proximal Tibia Plating System (K030597)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

JUN 1 4 2006

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anthony Francalancia<br>Senior Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | April 28, 2006 |
| Trade Name: | NCB® Plating System |
| Common Name: | Plate, Fixation, Bone<br>Screw, Fixation, Bone |
| Classification Reference: | 21 CFR § 888.3030, 3040 |
| Predicate Devices: | Zimmer NCB® Plating System, Humerus and<br>Femur Plates (K042695, cleared October 29, 2004).<br>Synthes 4.5mm Titanium LCP Proximal Tibia<br>Plating System (K023802, cleared January 28.<br>2003).<br>Synthes 3.5mm Titanium LCP Proximal Tibia<br>Plating System (K030597, cleared March 20, 2003). |
| Device Description: | The NCB Plating System is an extramedullary<br>internal fixation plate system to be used for<br>proximal tibia fractures. It is intended to be<br>implanted either percutaneously or by a traditional<br>open method. |
| Intended Use: | The NCB Plating System is indicated for temporary<br>internal fixation and stabilization of fractures and<br>osteotomies of long bones. |
| Comparison to Predicate Device: | The NCB Plating System Proximal Tibia plates<br>have the same intended use, similar performance<br>characteristics, are made of the same material and<br>are similar in design to the predicate devices. |

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Performance Data (Non-clinical):

The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.

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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

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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 [phone] or [phone] 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

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## 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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