The Zimmer Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.

Device Description

The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.

AI/ML Overview

The information provided in the document focuses on regulatory clearance for a medical device (Zimmer Periarticular Locking Plate System) and does not describe acceptance criteria, a study proving the device meets those criteria, or details regarding AI/algorithm performance. The document explicitly states that "Clinical data and conclusions were not needed for this device."

Therefore, I cannot extract the requested information as it is not present in the provided text.

Here's why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: No acceptance criteria or specific performance metrics are mentioned in terms of a study outcome. The document only states that "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." This is a general statement, not a detailed report of performance against specific criteria.
Sample sized used for the test set and the data provenance: No test set is described. The document refers to "non-clinical (laboratory) performance testing" but provides no details on samples, sizes, or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth establishment for a test set is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set or expert adjudication is described.
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 document is for a medical implant (bone plate system), not an AI diagnostic or assistance tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a bone fixation plate, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no ground truth for diagnostic or interpretative purposes is mentioned. The "ground truth" for a bone plate would typically be its mechanical integrity or biological response, which is assessed via laboratory and clinical (if required) testing, not expert consensus on images.
The sample size for the training set: Not applicable as this is not an AI/algorithm-based device.
How the ground truth for the training set was established: Not applicable as this is not an AI/algorithm-based device.

Summary

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DEC 1 0 2004

K043227 (pg 1 of 2)

Summary of Safety and Effectiveness

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Noah J. Bartsch, MSSpecialist, Corporate Regulatory AffairsTelephone: (574) 371-8552Fax: (574) 372-4605
Date:	November 18, 2004
Trade Name:	Zimmer® Periarticular Locking Plates
Classification Name	Plate, Fixation, Bone
Classification Reference:	21 CFR § 888.3030
Predicate Device:	Zimmer® Periarticular Locking Platesmanufactured by Zimmer, Inc., K040593, clearedApril 12, 2004.
Device Description:	The Zimmer Periarticular Locking Plate System is aplate and screw system intended for internalfracture fixation. The low-profile periarticularlocking plate is anatomically contoured and hasthreaded holes which accept locking screws tocreate a stable, fixed angle construct.
Intended Use:	The Zimmer Periarticular Locking Plate System isindicated for temporary internal fixation andstabilization of osteotomies and fractures, includingcomminuted fractures, supracondylar fractures,intra-articular and extra-articular condylar fractures,fractures in osteopenic bone, nonunions, andmalunions.
Comparison to Predicate Devices:	The Zimmer Periarticular Locking Plate System hasthe same intended use, operates with the samefundamental scientific technology, is manufacturedfrom the same materials using similar processes,and is similar in design to the predicate device.

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Performance Data:

The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.

Clinical data and conclusions were not needed for this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 that resembles a stylized caduceus or a symbol of health and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2004

Mr. Noah Bartsch, MS Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581

Re: K043227

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: II Product Code: HRS Dated: November 18, 2004 Received: November 22, 2004

Dear Mr. Bartsch:

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 such 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); 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.

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Page 2 - Mr. Noah Bartsch, MS

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Milburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, stylized "Z" enclosed in a circle, followed by the word "zimmer" in lowercase letters. The "Z" is bold and black, contrasting with the white background of the circle, while the word "zimmer" is also in black, creating a clear and recognizable brand identity.

Indications for Use

510(k) Number (if known):

Device Name:

Zimmer® Periarticular Locking Plate System

Indications for Use:

The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

Comminuted fractures .
Supracondylar fractures .
Intra-articular and extra-articular condylar 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)

(Division Sign-Off)
Page 1 of 1
Division of General, Restorative,
and Neurological Devices

510(k) Number K043227

0021

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.