NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE

K120772 · Zimmer GmbH · HRS · Jun 12, 2012 · Orthopedic

Device Facts

• Record ID: K120772
• Device Name: NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE
• Applicant: Zimmer GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Jun 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NCB Periprosthetic Trochanter Plate when used in combination with the NCB Periprosthetic Proximal Femur Plate, short (Length =115mm) is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the greater trochanter. The NCB Periprosthetic Trochanter Plate when used in combination with the NCB Periprosthetic Proximal Femur Plates (Length =245mm, 285mm, 324mm, 363mm, 401mm) is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the proximal femur. In addition, both combinations are indicated for: Re-attachment of the greater trochanter following osteotomy in THA; Re-attachment of the greater trochanter following fracture of greater trochanter; Periprosthetic fractures; Comminuted fractures; Fractures in osteopenic bone; Nonunions; Malunions. The Cable Button is intended for use in combination with the Zimmer Locking Bone Plating Systems and Cerclage Cables, to stabilize multiple fractures or butterfly fragments in long bones.

Device Story

System comprises NCB Periprosthetic Trochanter Plates, screws, and NCB Cable Buttons. Plates provide polyaxial screw placement (30-degree cone) via threaded conical holes and locking caps; Cable Buttons provide positioning points for cerclage cables in vacant plate holes. Used by orthopedic surgeons in clinical settings for temporary internal fixation of femur fractures and osteotomies. Devices stabilize bone fragments to facilitate healing. Non-clinical testing confirms mechanical integrity and performance equivalent to predicate systems.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing (torsional strength, fatigue strength, stiffness, and removal torque evaluations) and a literature review regarding use in osteopenic bone.

Technological Characteristics

Materials: Ti-6Al-4V alloy (Cable Button is color anodized). Design: Polyaxial locking plate system with 30-degree cone screw placement; threaded conical holes; locking caps. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients requiring temporary internal fixation and stabilization of proximal femur fractures, greater trochanter fractures, osteotomies, periprosthetic fractures, comminuted fractures, nonunions, and malunions, including in osteopenic bone. The Cable Button is indicated for stabilizing multiple fractures or butterfly fragments in long bones when used with locking plating systems and cerclage cables.

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 Periprosthetic Femur Polyaxial Locking Plate System (K100111)
• Pioneer Surgical Technology Extended GTR, Model 501-601 (K000734)
• Cable Ready Cable Grip System Cable Button (K091799)

Submission Summary (Full Text)

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K120772

JUN 1 2 2012

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 it. Below the circle, the word "zimmer" is written in a stylized font.

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

### 510(k) Summary

Sponsor:

Contact Person:

.
.
.

Date:

Trade Name:

Common Name:

Classification Names and References

Predicate Devices:

Zimmer, GmbH SulzerAllee 8 Winterthur, Switzerland CH-8404

Romil Sheth Associate, Trauma Regulatory Affairs Telephone: [phone] Fax: [phone]

March 12, 2012

This is a bundled traditional 510(k). The trade names of the two devices bundled in this submission are:

1) NCB Periprosthetic Trochanter Plates and Screws

2) NCB Cable Button for NCB Polyaxial Locking Plate

1) Locking Plate System

2) Washer, Bolt, Nut

1) Plate, Fixation, Bone (21 CFR 888.3030)

2) Washer, Bolt, Nut (21 CFR 888.3030)

- 1) NCB Periprosthetic Femur Polyaxial Locking Plate System, Manufactured by Zimmer, K100111, cleared April 12, 2010, and Pioneer Surgical Technology Extended GTR, Model 501-601, Manufactured by Pioneer Surgical Technology, K000734, cleared May 5, 2000.
- 2) Cable Ready® Cable Grip System Cable Button, Manufactured by Zimmer, K091799, cleared September 11,2009

14

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K120772 (pg. 2 of 4)

### Device Description:

1) The NCB (Non-Contact-Bridging) Periprosthetic Trochanter Plates and Screws are a line of locking plates for the treatment of proximal femur fractures, which includes greater trochanter fractures and osteotomies. The NCB Periprosthetic Trochanter Plate and the Connection Screw for NCB Periprosthetic Trochanter Plate are used in combination with the NCB Periprosthetic Proximal Femur Plate, short (Length =115mm). The NCB Periprosthetic Trochanter Plate can also be used in combination with the existing NCB Periprosthetic Proximal Femur Plates (Length =245mm, 285mm, 324mm, 363mm, 401mm) from the NCB Periprosthetic Femur Polyaxial Locking Plate System. The NCB System technology used on the NCB Periprosthetic Proximal Femur Plates allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the plate holes. The NCB Periprosthetic Trochanter Plate contains threaded conical holes which allow for monoaxial screw placement using locking screws with threaded heads. Non-locking cortical screws can also be used. All the plates are made of Ti-6Al-4V alloy. The Connection Screw for NCB Periprosthetic Trochanter Plate is also made of Ti-6Al-4V alloy.

2) The NCB Cable Button for NCB Polyaxial Locking Plate is a temporary internal fixation component used in conjunction with Zimmer NCB Plates, Zimmer NCB Periprosthetic Plates and Cerclage Cables. The Cable Button is threaded into a vacant screw hole of Zimmer NCB Plates or Zimmer NCB Periprosthetic Plates and provides a positioning point for a Cerclage Cable. The Cable Button is made up of Ti-6Al-4V alloy and is color anodized.

1) The NCB Periprosthetic Trochanter Plate when used in combination with the NCB Periprosthetic Proximal Femur Plate, short (Length =115mm) is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the greater trochanter.

The NCB Periprosthetic Trochanter Plate when used in combination with the NCB Periprosthetic Proximal Femur Plates (Length =245mm, 285mm, 324mm,

Intended Use:

15

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K120772 (pg. 3 of 4)

363mm. 401mm) is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the proximal femur.

In addition, both combinations are indicated for:

- · Re-attachment of the greater trochanter following osteotomy in THA
- · Re-attachment of the greater trochanter following fracture of greater trochanter
- · Periprosthetic fractures
- · Comminuted fractures
- · Fractures in osteopenic bone
- · Nonunions
- · Malunions

2) The Cable Button is intended for use in combination with the Zimmer Locking Bone Plating Systems and Cerclage Cables, to stabilize multiple fractures or butterfly fragments in long bones.

The NCB Periprosthetic Trochanter Plates and Screws as well as the NCB Cable Button for NCB Polyaxial Locking Plate are similar in intended use, materials, sterility, and performance characteristics to the predicate device(s).

Performance Data (Nonclinical

And/or Clinical):

Comparison to Predicate Device:

Non-Clinical Performance and Conclusions:

1) Testing/Analysis performed included; Torsional strength evaluation of the Connection Screw for NCB Periprosthetic Trochanter Plate, Fatigue strength evaluation of the NCB Periprosthetic Trochanter Plate with and without using cable and hex button, Fatigue strength evaluation of the Cable Ready Cable Grip System for Greater Trochanteric Reattachment (predicate device). Stiffness evaluation of the NCB Periprosthetic Trochanter Plate and Evaluation of Removal Torque of the ULS Tivanium® Ti-6Al-4V Alloy 3.5mm locking screws.

2) Testing/Analysis performed included; Evaluation of seating and removal torque of a NCB Cable Button and Loading analysis of a NCB Cable Button.

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Ki20772 (pg. 4 of

The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.

Also, a literature review was conducted to substantiate the use of the NCB Periprosthetic Trochanter Plates and Screws in osteopenic bone.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

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

Zimmer, GmbH % Mr. Romil Sheth Associate, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

JUN 1 2 2012

Re: K120772

Trade/Device Name: NCB Periprosthetic Trochanter Plates and Screws and NCB Cable Button for NCB Polyaxial Locking Plate

Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II

Product Code: HRS, HTN, HWC Dated: March 12, 2012 Received: March 14, 2012

Dear Mr. Sheth:

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.

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

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# Page 2 - Mr. Romil Sheth

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin Keith

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): ドレスクファ

#### Device Name:

NCB Periprosthetic Trochanter Plates and Screws

### Indications for Use:

The NCB Periprosthetic Trochanter Plate when used in combination with the NCB Periprosthetic Proximal Femur Plate, short (Length =1 1 5mm) is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the greater trochanter.

The NCB Periprosthetic Trochanter Plate when used in combination with the NCB Periprosthetic Proximal Femur Plates (Length =245mm, 324mm, 363mm, 401mm) is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the proximal femur.

In addition, both combinations are indicated for:

- · Re-attachment of the greater trochanter following osteotomy in THA
- Re-attachment of the greater trochanter following fracture of greater trochanter
- · Periprosthetic fractures
- Comminuted fractures
- · Fractures in osteopenic bone
- · Nonunions
- · Malunions

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)

Asnt

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120772

12

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# Indications for Use

# 510(k) Number (if known): 长/20772

### Device Name:

NCB Cable Button for NCB Polyaxial Locking Plate

### Indications for Use:

The Cable Button is intended for use in combination with the Zimmer Locking Bone Plating Systems and Cerclage Cables, to stabilize multiple fractures or butterfly fragments in 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)

Asif

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K12077

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