MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM

K101696 · Zimmer, Inc. · HWC · Sep 10, 2010 · Orthopedic

Device Facts

• Record ID: K101696
• Device Name: MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Sep 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• 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

MotionLoc Screw is a bone fixation component for the NCB Polyaxial Locking Plate System; used as an alternative to standard NCB screws to provide reduced construct stiffness. Device features a standard NCB front thread, a mid-section with reduced core-diameter, a collar region, and a standard NCB head. Screws provide unicortical fixation in the far cortex of a diaphysis; locked into the plate without rigid fixation in the near cortex. Used by surgeons in clinical settings for fracture stabilization. Benefits include reduced construct stiffness and maintenance of the Non-Contact Bridging concept, which reduces risk of periosteal blood supply impairment. System allows polyaxial screw placement (30° cone) with locking achieved via previously cleared locking caps.

Clinical Evidence

No clinical data was required or provided. Evidence consists of non-clinical bench testing and animal studies. Bench testing included construct fatigue testing (Distal Femur and Proximal Tibia plates with MotionLoc Screws), starting load, driving torque, and torque to failure testing. Animal testing was conducted using an ovine tibial osteotomy model.

Technological Characteristics

Materials: Titanium alloy. Sensing/Actuation: Mechanical bone fixation. Dimensions: Features a reduced core-diameter mid-section compared to standard NCB screws. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

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

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 Tibial Plates (K061211)
• NCB Plating System, Proximal Humeral Plates (K081759)

Submission Summary (Full Text)

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K101696

PG. 1/2

SEP 1 0 2010

P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

Image /page/0/Picture/2 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside. Below the circle, the word "zimmer" is written in a sans-serif font.

## Summary of Safety and Effectiveness

Sponsor:

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Stephen McKelvey Senior Project Manager, Regulatory Affairs Telephone: [phone] Fax: [phone] -

Date:

Trade Name:

Contact Person:

Common Name:

Classification Name and Reference:

Predicate Device:

Device Description:

September 1, 2010

MotionLoc™ Screw for NCB® Polyaxial Locking Plate System

Bone Screw

Screw, Fixation, Bone 21 CFR § 888.3040

NCB Plating System, K042695, cleared October 29, 2004; NCB Plating System, Proximal Tibial Plates, K061211, cleared June 14, 2006; NCB Plating System, Proximal Humeral Plates, K081759, cleared October 16, 2008.

The MotionLoc Screw for Polyaxial NCB Locking Plate System is used in conjunction with the NCB Polyaxial Locking Plate System. It is a member of the NCB Screw family and is used as an alternative for standard NCB Screws in applications where a surgeon desires reduced stiffness in a construct.

The MotionLoc Screw for Polyaxial NCB Locking Plate System has a standard NCB Screw front thread section, a mid-section with a reduced core-diameter, a collar region, and a standard NCB Screw head for engagement in NCB locking plates. The MotionLoc Screws provide unicortical fixation in the far cortex of a diaphysis and are locked into the plate, without being rigidly fixed in the near cortex underlying the plate.

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| | The <i>NCB</i> technology allows for polyaxial screw<br>placement (30° cone) of the <i>MotionLoc Screws</i> with<br>screw locking achieved using previously,cleared Locking<br>Caps (K042695, cleared 10/29/2004) that are threaded<br>into the plate holes. |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | In the locked mode the <i>NCB</i> plate acts as an internal<br>fixator without contact between the plate and the bone<br>surface thus reducing the risk of periosteal blood supply<br>impairment. This Non-Contact Bridging concept can be<br>specifically controlled through the use of 1, 2, or 3mm<br>spacers (also previously cleared in K042695), which are<br>threaded into the plate holes prior to plate insertion.<br>Plates, screws, spacers and locking caps are made of<br>titanium alloy. |
| Intended Use: | The <i>NCB</i> Polyaxial Locking Plate System is indicated for<br>temporary internal fixation and stabilization of fractures<br>and osteotomies of long bones. |
| Comparison to Predicate Device: | The <i>MotionLoc Screw</i> for <i>NCB</i> Polyaxial Locking Plate<br>System is similar in intended use, materials, sterility, and<br>performance characteristics to the predicate devices. See<br>the device description above for the design differences<br>between the proposed and predicate devices. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | The results of non-clinical (lab and animal) performance<br>testing demonstrate that the <i>MotionLoc Screw</i> for the<br><i>NCB</i> Polyaxial Locking Plate System presents no new<br>issues regarding safety and effectiveness as compared to<br>the predicate devices, and is substantially equivalent.<br>Testing/analysis performed included: Construct fatigue<br>testing (Distal Femur Plate with <i>MotionLoc Screws</i> ,<br>Proximal Tibia Plate with <i>MotionLoc Screws</i> ); Starting<br>load, driving torque and torque to failure testing<br>( <i>MotionLoc Screws</i> ); and Animal testing in an ovine<br>tibial osteotomy model (locking compression plate with<br>prototype <i>MotionLoc Screws</i> ). |
| | Clinical Performance and Conclusions: |
| | Clinical data and conclusions were not needed for this<br>device. |

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem resembling an abstract bird or human figure, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Zimmer, Inc. % Mr. Stephen McKelvey Senior Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581

SEP 1 0 2010

Re: K101696

Trade/Device Name: MotionLoc™ Screw for NCB® Polyaxial Locking Plate System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II · Product Code: HWC, HRS Dated: June 15, 2010

Received: June 16, 2010

Received: June 19, 2010

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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Stephen 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdaggv/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 yours,

Daulave Bnehup

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

K101696 510(k) Number (if known):

Device Name:

MotionLoc" Screw for NCB® Polyaxial Locking Plate System

Indications for Use:

The NCB® Polyaxial Locking Plate 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)

Ondate for mxm

(Dision Sign-9 Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101696

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SEP 1 0 2010

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