ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, and Contourable Dual Compression Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:

comminuted fractures
supracondylar fractures
extra-articular fractures
fractures in osteopenic bone
nonunions
malunions
Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.
ZPS Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneus. ZPS and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

Device Description

The Zimmer Plates and Screws System (ZPS) is a nonlocking, stainless steel plate and screw system. Plate shapes vary to address varying patient bone sizes and injury fragment sizes. Plates incorporate a spherical sliding slope plate hole design to achieve the compression required to treat bone fractures. The plates are used with a variety of screws for temporary fixation to the bone. The ZPS Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a larger area when used for non-plate, bone fragment, and fracture fixation.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the Zimmer® Plates and Screws System (ZPS) - Non-sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screws and Washers. It describes the device, its intended use, and a comparison to predicate devices. The document explicitly states that clinical data and conclusions were not needed for these devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC, standalone) is explicitly stated as not applicable or not needed in this document.

The document primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices through non-clinical performance data.

However, I can extract the non-clinical performance data that serves in place of clinical studies to demonstrate device performance and substantial equivalence.

Here's a breakdown of what the document does provide in relation to performance:

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

The document does not present a formal "acceptance criteria" table in the way one might expect for a clinical study with specific performance metrics (e.g., sensitivity, specificity). Instead, it relies on two primary non-clinical performance tests to demonstrate substantial equivalence to predicate devices. The acceptance criteria are implicitly that the subject device's performance should be "similar" or "substantially equivalent" to the predicate devices.

Acceptance Criteria (Implicit from Equivalence Claim)	Reported Device Performance (Non-Clinical)
Biocompatibility: Meet ISO 10993-1 and GLP	Biocompatibility testing on the plate, screw, and washer material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
Mechanical Properties (Beam Bending): Similar mechanical properties to predicate devices.	Beam bending cross sectional analysis of the ZPS Plates and the predicate devices, Zimmer Plate and Screw System (K140508) and the TMP Micro-Plating System (K921458), resulted in similar mechanical properties. The subject and predicate devices are substantially equivalent.
Screws and Washers Equivalence: Substantially equivalent to predicate screws/washers and considered line extensions.	The subject screws are substantially equivalent to those cleared in K140508 and are a line extension to screw types already cleared in K140508. The subject washers are substantially equivalent to and are a line extension to the washer cleared in K140508.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in terms of number of devices or units tested for the non-clinical tests. The tests were performed on "the plate, screw, and washer material" and "ZPS Plates" for beam bending. This would typically refer to a statistically sufficient sample for engineering tests, but the exact number isn't provided.
Data Provenance: The tests are non-clinical, likely conducted in a laboratory setting by the manufacturer (Zimmer, Inc.) or a contract research organization. There is no mention of country of origin for this data beyond the manufacturer's location (Warsaw, IN). The data is by nature prospective for the purpose of this submission.
Retrospective or Prospective: Prospective, as it was conducted specifically for the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For non-clinical performance tests such as biocompatibility and mechanical testing, "ground truth" is established by adherence to recognized standards (e.g., ISO 10993-1) and objective measurements using calibrated equipment, not by expert consensus.

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

Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation by multiple readers) or complex clinical outcomes. Non-clinical tests follow standardized protocols.

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 a medical device (bone plates and screws), not an AI/imaging diagnostic device. Clinical studies (including MRMC) were explicitly stated as "not needed."

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 consensus, pathology, outcomes data, etc)

For the non-clinical tests:

Biocompatibility: Established by adherence to ISO 10993-1 standards and the specific pass/fail criteria outlined within those standards and Good Laboratory Practices (GLP).
Mechanical Properties: Established by quantitative measurements of specific mechanical parameters (e.g., stiffness, strength) through standardized engineering test methods (beam bending cross-sectional analysis). "Similar mechanical properties" to the predicate serve as the ground truth for equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary

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

November 28, 2014

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

Re: K143066

Trade/Device Name: Zimmer® Plates and Screws System (ZPS) - Non-sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screws and Washers Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS, HTN, HWC Dated: October 23, 2014 Received: October 31, 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, 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

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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K143066

Device Name

Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS Plate Line Exterile ZPS Screws and Washers

Indications for Use (Describe)

ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, Cobra Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, and Contourable Dual Compression Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:

· comminuted fractures
· supracondylar fractures
· extra-articular fractures
· fractures in osteopenic bone
nonunions

• malunions

Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.

ZPS Calcaneal plates are indicated for temporary internal fixation of osteotomies and fractures of the calcaneus. ZPS and Forte 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 features the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized letter "Z" inside it. Below the circle, the word "zimmer" is written in lowercase letters, also in blue.

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:	October 23, 2014
Trade Name:	Zimmer® Plates and Screws System (ZPS) – Non-SterileZPS Plate Line Extensions, Sterile/Non-Sterile ZPSScrews and Washers
Common Name:	Temporary Internal Fixation Devices
Classification Namesand References:	Single/multiple component metallic bone fixationappliances and accessories (21 CFR 888.3030, HRS andHTN) and Smooth or threaded metallic bone fixationfastener (21 CFR 888.3040, HWC)
Classification Panel:	Orthopedics/87
Predicate Device(s):	Zimmer Plates and Screws System (ZPS) (K140508,cleared August 14, 2014)TMP Micro-plating System (Anspach/Techmedica,K921458, cleared July 17, 1992)
Purpose and Device Description:	The Zimmer Plates and Screws System (ZPS) is anonlocking, stainless steel plate and screw system. Plateshapes vary to address varying patient bone sizes andinjury fragment sizes. Plates incorporate a sphericalsliding slope plate hole design to achieve the compressionrequired to treat bone fractures. The plates are used with avariety of screws for temporary fixation to the bone. TheZPS Washers are intended to prevent a screw head frombreaking through the cortex of the bone by distributing the

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Intended Use:	forces/load over a larger area when used for non-plate, bone fragment, and fracture fixation.
	ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, and Contourable Dual Compression Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:
	comminuted fracturessupracondylar fracturesextra-articular fracturesfractures in osteopenic bonenonunionsmalunions
	Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.
	ZPS Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneus. ZPS and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.
Comparison to Predicate Device:	The ZPS Plates, Screws and Washers are similar in intended use, basic shape, compatible diameters, materials and performance characteristics to the predicate devices.
Performance Data (Nonclinical and/or Clinical):	Non-Clinical Performance and Conclusions:
	Biocompatibility - Biocompatibility testing on the plate, screw, and washer material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.Beam bending cross sectional analysis of the ZPS Plates and the predicate devices, Zimmer Plate and Screw System (K140508) and the TMP Micro-Plating System (K921458), resulted in similar mechanical properties. The subject and predicate devices are substantially equivalent.The subject screws are substantially equivalent to those cleared in K140508 and are a line extension to screw types already cleared in K140508.

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The subject washers are substantially equivalent to and . are a line extension to the washer cleared in K140508.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for . these 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.