This submission covers minor design modifications and line extensions of the Zimmer Periarticular Locking Plate System. The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile locking plates are anatomically contoured and have threaded holes that accept locking screws to create a stable, fixed angle construct.

AI/ML Overview

The provided document describes the predicate device and the Zimmer Periarticular Locking Plate System, but does not provide acceptance criteria or a study demonstrating that the device meets those criteria.

Instead, the document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device. This type of submission relies heavily on non-clinical performance data and does not typically include a detailed report of clinical acceptance criteria met by the device.

Here's what can be extracted and what information is missing based on your request:

Missing Information (Not provided in the document):

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria for device performance. It states that "All testing passed" for biocompatibility and that performance testing included "engineering analysis, as well as dynamic/fatigue construct testing, evaluation of screw torsional failure strength, driving torque, and axial pull out strength," and that "the results...demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices." No specific thresholds or performance values are reported to form such a table.
2. Sample size used for the test set and the data provenance: This information is not provided for the non-clinical tests mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device does not involve expert-based ground truth establishment in the context of clinical image analysis or diagnostics.
4. Adjudication method for the test set: Not applicable for the non-clinical tests described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The document explicitly states: "Clinical data and conclusions were not needed for these devices to show substantial equivalence." This means there was no human-in-the-loop study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (orthopedic plate and screw system), not an algorithm or AI.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" would be established by the physical and mechanical properties being measured and compared against engineering specifications or predicate device performance. For biocompatibility, it's established by ISO standards.
8. The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Information provided (related to non-clinical performance):

Device Name: Zimmer® Periarticular Locking Plate System
Purpose of Submission: Minor design modifications and line extensions of the existing Zimmer Periarticular Locking Plate System (K042598, K082078, K111039).
Non-Clinical Performance Tests Performed:
- Shelf Life: Accelerated aging testing
- Biocompatibility: Testing per ISO 10993-1 and Good Laboratory Practices (21 CFR 58)
- Performance Testing: Engineering analysis, dynamic/fatigue construct testing, evaluation of screw torsional failure strength, driving torque, and axial pull out strength.
Conclusion of Non-Clinical Performance: "The results of non-clinical performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices."
Clinical Data: "Clinical data and conclusions were not needed for these devices to show substantial equivalence."

In summary, the document outlines a 510(k) clearance process based on substantial equivalence to predicate devices, supported by non-clinical testing. It does not provide the kind of detailed acceptance criteria and study results you would expect for a new diagnostic device or AI algorithm, particularly in a multi-reader multi-case or standalone performance context.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other.

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

August 13, 2014

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

Re: K141734 Trade/Device Name: Zimmer® Periarticular Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: June 26, 2014 Received: June 27, 2014

Dear Mr. Stephen H. 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 H. 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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 vours.

Lori A. Wiggins

for

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K141734

Device Name

Zimmer Periarticular Locking Plate System

Indications for Use (Describe)
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The Zimmer Periarticular Locking Plate System is indicated for temporary internal fixation of osteotomies and fractures, including:

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

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside it. Below the circle, the word "zimmer" is written in blue lowercase letters.

510(k) Summary

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Stephen H. McKelveySenior Project Manager, Trauma Regulatory AffairsTelephone: (574) 372-4944Fax: (574) 371-8760
Date:	June 26, 2014
Trade Name:	Zimmer® Periarticular Locking Plate System
Common Name:	Periarticular Locking Plates and Screws
Classification Namesand References:	Single/Multiple Component Metallic Bone FixationAppliances and Accessories (21 CFR 888.3030); Smoothor Threaded Metallic Bone Fixation Fastener (21 CFR888.3040)
Classification Panel:	Orthopedics/87, Product codes HRS, HWC
Predicate Device(s):	Zimmer Periarticular Locking Plate System(K042598, K082078, K111039)
Purpose and DeviceDescription:	This submission covers minor design modifications andline extensions of the Zimmer Periarticular Locking PlateSystem. The Zimmer Periarticular Locking Plate Systemis a plate and screw system intended for internal fracturefixation. The low-profile locking plates are anatomicallycontoured and have threaded holes that accept lockingscrews to create a stable, fixed angle construct.
Intended Use:	The Zimmer Periarticular Locking Plate System isindicated for temporary internal fixation and stabilizationof osteotomies and fractures, including comminutedfractures, supracondylar fractures, intra-articular andextra-articular condylar fractures, fractures in osteopenicbone, nonunions, and malunions

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Comparison to Predicate Device:	The Zimmer Periarticular Locking Plate System plates andscrews covered by this submission are similar in intendeduse, design, compatible screw diameters, materials, andperformance characteristics to the predicate devices.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:

. Shelf Life - Accelerated aging testing conducted shows that the sterile devices included in this submission have a shelf life of 10 years.
. Biocompatibility - Biocompatibility testing of the subject devices was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
. Performance Testing - Testing performed included engineering analysis, as well as dynamic/fatigue construct testing, evaluation of screw torsional failure strength, driving torque, and axial pull out strength.

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

Conclusions: The non-clinical performance data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject devices will perform in a substantially equivalent manner to the predicate devices.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for these devices to show substantial equivalence.

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.