MotionLoc Screws, when used with the NCB Proximal Humeral or NCB Proximal Tibial plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:

Comminuted fractures
Fractures in osteopenic bone
Nonunions/Malunions

MotionLoc Screws, when used with the NCB Distal Femoral plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:

Comminuted fractures
Supracondylar fractures
Fractures in osteopenic bone
Nonunions/Malunions

MotionLoc Screws, when used with the NCB Straight Narrow Shaft plates, are indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including:

Periprosthetic fractures
Comminuted fractures
Fractures in osteopenic bone
Nonunions/Malunions

MotionLoc Screws, when used with the NCB Periprosthetic Proximal Femur, Distal Femur or Curved Femur Shaft plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:

Periprosthetic fractures
Comminuted fractures
Supracondylar fractures
Fractures in osteopenic bone
Nonunions/Malunions

Device Description

The MotionLoc Screw 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 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. The NCB technology allows for polyaxial screw placement (30° cone) of the MotionLoc Screws with screw locking achieved using previously cleared Locking Caps (K042695, cleared 10/29/2004) that are threaded into the plate holes.

In the locked mode the NCB plate acts as an internal fixator without contact between the plate and the bone surface thus reducing the risk of periosteal blood supply impairment. This Non-Contact Bridging concept can be specifically controlled through the use of 1, 2, or 3mm spacers (also previously cleared in K042695), which are threaded into the plate holes prior to plate insertion. Plates, screws, spacers and locking caps are made of titanium alloy.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Zimmer MotionLoc™ Screw for NCB® Polyaxial Locking Plate System, based on the provided document:

This 510(k) submission is for an extension of indications for an already cleared device, not a new device requiring extensive clinical trials to prove efficacy from scratch. Therefore, the "acceptance criteria" and "study" are primarily focused on demonstrating that the changes in indications or usage do not negatively impact the safety and effectiveness, and that the device remains substantially equivalent to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance	Assessment
Sterilization Validation	Sterilization efficacy to a SAL of 10⁻⁶ or better for a minimum gamma dose of 20kGy.	Devices validated to demonstrate terminal sterilization to a SAL of 10⁻⁶ or better at 20kGy.	Met (No change in sterilization method or efficacy with new indications/reduced screw count).
Shelf Life	Maintain integrity and sterility over specified shelf life.	Accelerated aging showed a shelf life of 10 years.	Met (No change in shelf life with new indications/reduced screw count).
Sterile Packaging	Withstand normal distribution and storage conditions while maintaining sterile barrier properties.	Packaging has not changed and can withstand normal distribution/storage, maintaining sterile barrier.	Met (No change in packaging).
Biocompatibility	Meet ISO 10993-1 and Good Laboratory Practices (21 CFR § 58) for implant materials.	All biocompatibility testing passed.	Met (No change in materials).
Mechanical Performance (New Indications/Reduced Screw Count)	Maintain safety and effectiveness with new compatible plates and reduced screw count (four to three in the shaft).	Non-clinical (lab) performance testing demonstrated safety and effectiveness and substantial equivalence to predicate devices when used with newly indicated plates and three screws. Specifically included: Axial fatigue strength and Torsional fatigue.	Met (Mechanical testing supported the changes).
Performance in Osteopenic Bone	Maintain safety and effectiveness for fractures in osteopenic bone.	Data from included literature references indicates the devices are safe and effective for the newly indicated bone quality (osteopenic).	Met (Supported by literature).

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

Since this is primarily a non-clinical (lab) performance study with literature review for osteopenic bone, the concept of a "test set" in the same way as a clinical trial with patient data is not applicable.

Mechanical Testing (Axial and Torsional Fatigue): The document does not specify the exact sample size (number of constructs tested) for the axial fatigue strength and torsional fatigue tests. This information is typically detailed in the specific test reports submitted to the FDA but is summarized in the 510(k).
Data Provenance: The document does not explicitly state the country of origin for the lab testing. It's safe to assume it's retrospective relative to the 510(k) submission, meaning the tests were conducted prior to the submission. The literature review for osteopenic bone would draw from published studies.

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

Not applicable in the context of this 510(k) summary. This submission did not involve a clinical study for which human experts would establish "ground truth" on performance relative to a disease state or imaging interpretation. The "ground truth" for the non-clinical tests is established by engineering principles and test standards.

4. Adjudication Method for the Test Set

Not applicable. There was no human judgment or interpretation requiring an adjudication process for the non-clinical lab tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not done. This type of study is typically used for diagnostic devices that require human interpretation (e.g., radiology images) to assess the impact of AI assistance on human reader performance. This device is a surgical implant.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a mechanical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

For mechanical performance (fatigue, strength): Engineering standards, physical measurements, and established biomechanical principles.
For biological aspects (biocompatibility, sterilization): International standards (ISO 10993-1), FDA regulations (21 CFR § 58), and industry best practices.
For osteopenic bone indication: Peer-reviewed medical literature.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical implant, not a machine learning model, so there is no "training set."

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

Not applicable. No training set was used.

Summary

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

K123918 510(k) Summary

page 1 of 4

FEB 14 2013

Sponsor:

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

Contact Person:

Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 371-8760

Date:

Trade Name:

Zimmer . MotionLoc™ Screw for NCB® Polyaxial Locking Plate System

Common Name:

Classification Names and References:

Classification Panel:

Predicate Devices:

Purpose and Device Description:

Zimmer . MotionLoc Screw for NCB Polyaxial Locking Plate
System

Bone Screw

December 18, 2012

Plate, Fixation, Bone (21 CFR 888.3030, Product Code HRS)

Orthopedics/87

The predicate devices are:

Zimmer MotionLoc Screw For NCB Polyaxial Locking Plate . System, K101696, cleared September 10, 2010
. Zimmer NCB Periprosthetic Femur Polyaxial Locking Plate System (K100111, cleared April 12, 2010)
Zimmer NCB Straight Narrow Shaft Plates (K113718, cleared . January 27, 2012)
Synthes 4.5mm Locking Compression Plate (LCP) with . Extended Indications (K082807, cleared January 13, 2009)

This submission extends the indications of the existing MotionLoc Screw for NCB Polyaxial Locking Plate System by adding to the list of compatible plates to include the NCB Periprosthetic Proximal Femur, Distal Femur, Curved Femur Shaft and Straight Narrow Shaft plates and by allowing the MotionLoc screw to be used for fractures in osteopenic bone. In addition, this submission decreases the number of required MotionLoc screws in the shaft of the bone from four to three.

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The MotionLoc Screw 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.

Intended Use:

· Comminuted fractures
· Fractures in osteopenic bone
· Nonunions/Malunions

MotionLoc Screws, when used with the NCB Distal Femoral plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:

· Comminuted fractures
· Supracondylar fractures
· Fractures in osteopenic bone
· Nonunions/Malunions

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· Periprosthetic fractures
· Comminuted fractures
· Fractures in osteopenic bone
· Nonunions/Malunions

· Periprosthetic fractures
· Comminuted fractures
· Supracondylar fractures
· Fractures in osteopenic bone
Nonunions/M
alunions
.

The physical attributes (dimensions, materials, specifications manufacturing processes, etc.) have not changed from the predicate MotionLoc Screws. They still have a standard NCB Screw front thread section, a mid-section with a reduced corediameter, a collar region, and a standard NCB Screw head for engagement in NCB locking plates. As before, these 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.

The NCB technology allows for polyaxial screw placement (30° cone) of the MotionLoc Screws with screw locking achieved using previously cleared Locking Caps (K042695, cleared 10/29/2004) that are threaded into the plate holes.

The proposed device is similar in intended use to the predicate devices.

Comparison to Predicate Devices:

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Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

Sterilization Validation - Sterilization has not changed with the new indications or reducing the number of required MotionLoc screws in the shaft of the bone from four to three. These devices have been validated to demonstrate that at a minimum gamma dose of 20kGy these screws can be terminally sterilized to a SAL of 10° or better.

Shelf Life - Shelf life has not changed with the new indications or reducing the number of required MotionLoc screws in the shaft of the bone from four to three. Accelerated aging showed that these sterile screws have a shelf life of 10 years.

Sterile Packaging - Packaging has not changed. The sterile screws can withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life.

Biocompatibility - Biocompatibility testing on the screw implant materials was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.

The new indications or reducing the number of required MotionLoc screws in the shaft of the bone from four to three does not change the fundamental scientific technology of any of the devices. Each sterile device uses the same operating principle and incorporates the same basic labeling.

Testing/Literature - The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices when used with the newly indicated plate and for use with three screws. Testing/analysis performed included axial fatigue strength and torsional fatigue. In addition, data from the included literature references indicates that the devices are safe and effective for the newly indicated bone quality (osteopenic).

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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

February 14. 2013

Zimmer. Incorporated % Stephen H. McKelvey, MA, RAC Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K123918

Trade/Device Name: Zimmer® MotionLoc™ Screw for NCB® Polyaxial Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener

Regulatory Class: Class II Product Code: HRS Dated: December 18, 2012 Received: December 19, 2012

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. Iisting 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

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Page 2 - Stephen H. McKelvey, MA, RAC

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K123918

Device Name:

Zimmer® MotionLoc™ Screw For NCB® Polyaxial Locking Plate System

Indications for Use:

· Comminuted fractures
· Fractures in osteopenic bone
· Nonunions/Malunions

MotionLoc Screws, when used with the NCB Distal Femoral plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:

· Comminuted fractures
· Supracondylar fractures
· Fractures in osteopenic bone
· Nonunions/Malunions

· Periprosthetic fractures
· Comminuted fractures
· Fractures in osteopenic bone
· Nonunions/Malunions

· Periprosthetic fractures
· Comminuted fractures
· Supracondylar 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)

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Division of Orthopedic Devices

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.