Zimmer MotionLoc Screws, when used with the Periarticular Locking Plate System are indicated for temporary internal fixation and stabilization of osteotomies and fractures of long bones, including:

Comminuted fractures
Supracondylar fractures
Intra-articular and extra-articular condylar fractures
Fractures in osteopenic bone
Nonunions
Malunions

Device Description

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

Zimmer MotionLoc technology has been developed to reduce the stiffness of locked plating constructs while retaining construct strength. This Zimmer MotionLoc technology relies on a screw design with a reduced diameter mid-section. These screws provide uni-cortical 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 screw mid-section decreases the stiffness of the plating construct by acting as an elastic cantilever beam similar to a half-pin of an external fixator.

The Zimmer MotionLoc Screw for Periarticular Locking Plate System has a standard ZPLP Screw front thread section (self-tapping, single helix); an expansion section, intended to create the gap for motion in the near cortex; a mid-section thread with a reduced core-diameter and reverse cutting flutes to aid in screw removal, especially once the front thread screw section is out of the far cortex; a non-threaded collar section; and a double lead threaded head for engagement in the plate.

AI/ML Overview

Here's an analysis of the provided text regarding the Zimmer MotionLoc Screw for Periarticular Locking Plate System, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Analysis (Acceptance Criteria Implicit)	Reported Device Performance
Structural Integrity	Torsional fatigue (3.5mm Proximal Tibia Plate with Zimmer MotionLoc Screws)	Results demonstrate safety and effectiveness, substantially equivalent to predicate.
	Axial fatigue (3.5mm and 4.5mm Proximal Tibia Plate with Zimmer MotionLoc Screws)	Results demonstrate safety and effectiveness, substantially equivalent to predicate.
Mechanical Performance	Starting load for Zimmer MotionLoc Screws	Results demonstrate safety and effectiveness, substantially equivalent to predicate.
	Driving torque for Zimmer MotionLoc Screws	Results demonstrate safety and effectiveness, substantially equivalent to predicate.
	Torque to failure for Zimmer MotionLoc Screws	Results demonstrate safety and effectiveness, substantially equivalent to predicate.
Design Validation	Finite element analysis (to assist in determining worst cases for physical testing)	Used to inform physical testing; results contribute to overall safety and effectiveness conclusion.

Note on Acceptance Criteria: The document does not explicitly state specific numerical acceptance criteria (e.g., minimum torque to failure in Nm, or fatigue cycles). Instead, it broadly states that the "results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective for their intended use and substantially equivalent to the predicate devices." This implies that the performance met internal benchmarks or demonstrated equivalence to the predicate's known performance.

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

Sample Size: Not explicitly stated. The document mentions "physical testing" and various types of tests (torsional fatigue, axial fatigue, starting load, driving torque, torque to failure), but does not provide the number of samples or specimens tested for each.
Data Provenance: The studies were non-clinical (lab) performance testing. The country of origin is not specified, but the sponsor is Zimmer, Inc. (USA), and the submission is to the FDA (USA). The data is prospective in the sense that the tests were conducted specifically to evaluate this device.

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

Not Applicable. This was a non-clinical (lab) performance study of a bone screw. Ground truth in this context refers to engineering specifications and material science principles, not expert medical opinion on, for example, image interpretation. There was no "test set" requiring human expert ground truth establishment in the traditional sense of medical image analysis or clinical diagnosis.

4. Adjudication Method for the Test Set

Not Applicable. As this was a non-clinical, lab-based performance study, there was no need for adjudication of human interpretations or diagnoses. The results are objective measurements from mechanical tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not conducted. This type of study involves human readers evaluating medical cases, often with and without AI assistance. The submitted device is a physical bone screw, not an AI software or a diagnostic tool that interacts with human readers in that manner.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in spirit. The "Performance Data (Nonclinical)" section describes the standalone performance of the device itself through various mechanical tests. These tests assess the device's inherent properties and behavior without human intervention in operating or interpreting the device's output (beyond setting up the test and collecting data). The device itself (the screw) is the "algorithm" here, and its performance is measured directly.

7. Type of Ground Truth Used

Engineering Specifications / Mechanical Properties: The "ground truth" for this study is derived from established engineering principles, material science, and the mechanical performance characteristics of the predicate devices. The implicit target is that the Zimmer MotionLoc Screw meets or exceeds the mechanical requirements for its intended use and is comparable to previously cleared predicate devices.

8. Sample Size for the Training Set

Not Applicable. This refers to a physical medical device, not an AI model that requires a training set of data.

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

Not Applicable. As there is no training set mentioned or implied for this physical device.

Summary

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K130810 (pg 1/3)

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

Summary of Safety and Effectiveness

SEP 19 2013

Sponsor:

Contact Person:

200000000000000

Date:

Trade Name:

Common Name:

Classification Name and Reference:

Predicate Device:

Device Description:

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

Scott M. Durlacher Principal Regulatory Consultant, Anson Group Telephone: (317) 569-9500 Fax: (317) 569-9520

July 12, 2013

Zimmer® MotionLoc™ Screw for Periarticular Locking Plate System

Bone Screw

Screw, Fixation, Bone (21 CFR § 888.3040, Product Code HWC)

Periarticular Locking Plates and Screws, 2357 and 2359 Series, K042598, cleared October 29, 2004; Periarticular Locking Plates, 2358 Series, K043227, cleared December 10, 2004; Zimmer Periarticular Locking Plate System. Model 2357 and 2359. K050121. cleared January 31, 2005; Zimmer Periarticular Locking Plate System, K111039, cleared May 19, 2011; Smith & Nephew PERI-LOC™ Periarticular Locked Plating System Locking Bone Plates for Lower and Upper Extremity, K092015, cleared July 30, 2009; MotionLoc " Screw for NCB® Polyaxial Locking Plate System, K101696, cleared September 10, 2010; Zimmer® MotionLoc " Screw for NCB® Polyaxial Locking Plate System, K123918, cleared February 14. 2013

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alternative for standard ZPLP Screws in applications where a surgeon desires reduced stiffness in a construct.

Zimmer MotionLoc Screws, when used with the Periarticular Locking Plate System are indicated for temporary internal fixation and stabilization of osteotomies and fractures of long bones, including:

Comminuted fractures ●
. Supracondylar fractures
. Intra-articular and extra-articular condylar fractures
Fractures in osteopenic bone .
Nonunions .
o Malunions

The Zimmer MotionLoc Screw for Periarticular Locking Plate System is similar in intended use, sterility, and performance characteristics to the predicate devices. See the device description above for the design differences between the proposed and predicate devices.

Intended Use:

Comparison to Predicate Device:

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Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective for their intended use and substantially equivalent to the predicate devices. Testing/analysis performed included: finite element analysis to assist in determining worst cases to test for physical testing; torsional fatigue -3.5mm Proximal Tibia Plate with Zimmer MotionLoc Screws; axial fatigue – 3.5mm and 4.5mm Proximal Tibia Plate with Zimmer MotionLoc Screws; starting load, driving torque, and torque to failure for Zimmer MotionLoc Screws.

Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.

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Image /page/3/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that form the body and wings, with a smaller curved line representing the head and beak.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G603 Silver Spring, MD 20993-0002

September 19, 2013

Zimmer, Incorporated % Mr. Scott M. Durlacher Anson Group 9001 Wesleyan Road Suite 200 Indianapolis. Indiana 46268

Re: K130810

Trade/Device Name: Zimmer® MotionLoc" Screw for Periarticular Locking Plate System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: July 12, 2013 Received: July 15, 2013

Dear Mr. Durlacher:

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 cnclosure) 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 cither 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

{4}------------------------------------------------

Page 2 - Mr. Scott M. Durlacher

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Anton E. Dmitriev

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

Enclosure

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Indications for Use

510(k) Number (if known): K130810 (pg 1/1)

Device Name:

Zimmer® MotionLoc™ Screw for Periarticular Locking Plate System

Indications for Use:

Zimmer MotionLoc Screws, when used with the Periarticular Locking Plate System are indicated for temporary internal fixation and stabilization of osteotomies and fractures of long bones, including:

Comminuted fractures .
Supracondylar fractures .
Intra-articular and extra-articular condylar fractures �
Fractures in osteopenic bone .
Nonunions 0
. 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)

Elizabeth L. Frank -S

Page 1 of 1

ו ז

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.