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

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 Description

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.
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.

AI/ML Overview

This 510(k) summary (K120772) describes the Zimmer NCB Periprosthetic Trochanter Plates and Screws and the NCB Cable Button for NCB Polyaxial Locking Plate. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-clinical submission for orthopedic implants, the "acceptance criteria" and "reported device performance" are typically defined by engineering standards for mechanical strength, fatigue, and other biomechanical properties. The document does not provide specific numerical acceptance criteria or performance values beyond stating that the testing "demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices."

The types of tests performed indicate the implicit acceptance criteria:

Acceptance Criteria (Implied)	Reported Device Performance
NCB Periprosthetic Trochanter Plates and Screws:
Torsional strength of Connection Screw	Demonstrated safety, effectiveness, and substantial equivalence to predicate devices.
Fatigue strength of Periprosthetic Trochanter Plate (with/without cable and hex button)	Demonstrated safety, effectiveness, and substantial equivalence to predicate devices.
Stiffness of Periprosthetic Trochanter Plate	Demonstrated safety, effectiveness, and substantial equivalence to predicate devices.
Removal Torque of ULS Tivanium® Ti-6Al-4V Alloy 3.5mm locking screws	Demonstrated safety, effectiveness, and substantial equivalence to predicate devices.
NCB Cable Button for NCB Polyaxial Locking Plate:
Seating and Removal Torque of Cable Button	Demonstrated safety, effectiveness, and substantial equivalence to predicate devices.
Loading analysis of Cable Button	Demonstrated safety, effectiveness, and substantial equivalence to predicate devices.
Overall: Substantial equivalence to predicate devices for intended use, materials, sterility, and performance characteristics.	The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact number of samples (e.g., number of plates, screws, cable buttons) used for each non-clinical test. This information is typically detailed in the full test reports, which are not included in this summary.
Data Provenance: The data is from non-clinical (lab) performance testing. The location of the testing is not explicitly stated, but Zimmer's address is Switzerland, and the contact person is in Indiana, USA. However, the tests are physical engineering tests, not involving human or clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. For a non-clinical submission involving mechanical testing of orthopedic implants, "ground truth" is established by adherence to recognized engineering standards and methodologies (e.g., ASTM, ISO). The performance is assessed against these standards and compared to previously cleared predicate devices, not against expert human interpretations of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring adjudication of expert opinions. The "adjudication" in a non-clinical context would be the review and verification of test protocols, data, and conclusions by qualified engineers and regulatory specialists.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This submission is for mechanical orthopedic implants, not an AI software device, and therefore no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This submission is for mechanical orthopedic implants, not an AI software device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established engineering principles, biomechanical testing standards, and comparative performance to legally marketed predicate devices. This includes:

Physical measurements of strength, stiffness, fatigue life, and other mechanical properties.
Conformity to material specifications (Ti-6Al-4V alloy).
Demonstration of substantial equivalence to the performance characteristics of predicate devices in identical or similar non-clinical tests.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not a machine learning or AI device that requires a training set or its associated ground truth establishment.

Summary

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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: (574) 371-1621 Fax: (574) 371-8760

March 12, 2012

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

NCB Periprosthetic Trochanter Plates and Screws
NCB Cable Button for NCB Polyaxial Locking Plate
Locking Plate System
Washer, Bolt, Nut
Plate, Fixation, Bone (21 CFR 888.3030)
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.
1. Cable Ready® Cable Grip System Cable Button, Manufactured by Zimmer, K091799, cleared September 11,2009

{1}------------------------------------------------

K120772 (pg. 2 of 4)

Device Description:

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.
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.
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:

{2}------------------------------------------------

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

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:

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

{3}------------------------------------------------

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

{5}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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:

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

{7}------------------------------------------------

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

। उ

Regulation Number and Section

§ 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.