Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and stabilization of fractures and osteotomies of the distal radius, including associated carpal fusions.

Periarticular Plating System Calcaneal plates are indicated for complex extra-articular fractures and osteotomies of the calcaneus.

Periarticular Plating System screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

Device Description

The Zimmer Periarticular Plating System consists of temporary implants (plates and screws) and instrumentation for the management of periarticular bone fractures through interfragmentary compression and bone plating. Bone screws are provided for use with or without bone plates for fractures. This submission covers non-sterile versions of previously cleared sterile Zimmer Periarticular Plating System screws and various sizes of the following sterile plates: Distal Volar Radial Radius, Distal Volar Ulnar Radius, Lateral Calcaneal.

AI/ML Overview

This document is a 510(k) premarket notification for the Zimmer Periarticular Plating System. It describes the device, its intended use, and its substantial equivalence to predicate devices. The information provided is primarily related to regulatory approval and does not contain details about a study designed to prove the device meets specific acceptance criteria in terms of diagnostic performance or clinical outcomes.

Here's a breakdown of why the requested information cannot be fully provided based on this document:

Type of Device: The Zimmer Periarticular Plating System is a medical implant (plates and screws for bone fixation), not a diagnostic device or an AI-powered system that would typically undergo performance studies with acceptance criteria like sensitivity, specificity, or reader studies.
Regulatory Pathway: This is a 510(k) submission, indicating a claim of substantial equivalence to already legally marketed predicate devices. This pathway primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, rather than requiring extensive de novo clinical trials to prove efficacy against acceptance criteria.

Therefore, many of the requested points are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract the information that is present and explain why other points are not.

1. A table of acceptance criteria and the reported device performance

This document does not specify "acceptance criteria" in the sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or detailed clinical outcome success rates for a study designed to prove the device meets those criteria. Instead, the "performance" described is about non-clinical aspects related to safety and function for substantial equivalence.

Performance Aspect	Reported Device Performance
Shelf Life	10 years (based on accelerated aging testing)
Biocompatibility	All testing passed (per ISO 10993-1 and 21 CFR 58 GLP)
Mechanical Performance	Demonstrated safe and effective, and substantially equivalent to predicate devices (via engineering analysis)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The performance data is based on non-clinical testing (shelf life, biocompatibility, engineering analysis), not human clinical data with a "test set" of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no clinical test set for which ground truth needed to be established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring adjudication.

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 is not an AI-powered or diagnostic device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable to the clinical performance. For the non-clinical performance:

Shelf Life: Determined by laboratory accelerated aging protocols.
Biocompatibility: Determined by laboratory testing against ISO 10993-1 and 21 CFR 58 GLP.
Mechanical Performance: Determined by engineering analysis and comparison to predicate device specifications and performance.

8. The sample size for the training set

Not applicable. This is not a device developed through machine learning.

9. How the ground truth for the training set was established

Not applicable.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized 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

October 22, 2014

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

Re: K142579

Trade/Device Name: Zimmer® Periarticular Plating 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: September 12, 2014 Received: September 15, 2014

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

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Page 2 - Mr. Stephen H. McKelvey

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,

Lori A. Wiggins -S

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)

K142579

Device Name

Zimmer Periarticular Plating System

Indications for Use (Describe)

Periarticular Plating System Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and stabilization of fractures and osteotomies of the distal radius, including associated carpal fusions.

Periarticular Plating System Calcaneal plates are indicated for complex extra-articular fractures and osteotomies of the calcaneus.

Periarticular Plating System screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a stylized blue letter "Z" inside of a blue circle. Below the circle is the word "zimmer" in lowercase blue 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) 372-4605
Date:	September 12, 2014
Trade Name:	Zimmer® Periarticular Plating System
Common Name:	Periarticular Non-locking Plates and Screws
Classification Namesand References:	Single/Multiple Component Metallic Bone FixationAppliances and Accessories, 21 CFR 888.3030 (HRS);Smooth or Threaded Metallic Bone Fixation Fastener 21CFR 888.3040 (HWC)
Classification Panel:	Orthopedics/87
Predicate Device(s):	Zimmer Periarticular Plating System Screws (K111447)Synthes Distal Radius Plate System (K982732)Synthes Calcaneal Plate (K020401)
Purpose and DeviceDescription:	The Zimmer Periarticular Plating System consists oftemporary implants (plates and screws) andinstrumentation for the management of periarticular bonefractures through interfragmentary compression and boneplating. Bone screws are provided for use with or withoutbone plates for fractures. This submission covers non-sterile versions of previously cleared sterile ZimmerPeriarticular Plating System screws and various sizes ofthe following sterile plates: Distal Volar Radial Radius,Distal Volar Ulnar Radius, Lateral Calcaneal.

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Intended Use:	Small Distal Volar Radial Radius and Small Distal VolarUlnar Radius plates are indicated for temporary internalfixation and stabilization of fractures and osteotomies ofthe volar aspect of the distal radius, including associatedcarpal fusions. Calcaneal plates are indicated for complexextra-articular and intra-articular fractures and osteotomiesof the calcaneus. Screws are temporary internal fixationdevices designed to stabilize fractures during the normalhealing process.
Comparison to Predicate Device:	The Zimmer Periarticular Plating System plates andscrews covered by this submission are substantiallyequivalent to the predicate devices, in that they have thesame intended use, function, and fundamental scientifictechnology. The differences between the subject andpredicate devices do not raise new issues of safety oreffectiveness.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:
	• Shelf Life - Accelerated aging testing conductedshows that the sterile devices included in thissubmission have a shelf life of 10 years.
	• Biocompatibility – Biocompatibility testing of thesubject devices was conducted per ISO 10993-1 andGood Laboratory Practices (21 CFR 58). All testingpassed.
	• Performance Testing – Engineering analysisdemonstrates the devices are safe and effective andsubstantially equivalent to the predicate devices.
	Conclusions: The non-clinical performance data presentedin this submission show the subject devices will performin a substantially equivalent manner to the predicatedevices.
	Clinical Performance and Conclusions:
	Clinical data and conclusions were not needed for thesedevices 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.