ZPS One-Third Tubular Plates, T-Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloverleaf and Spoon 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 ostectomies 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 ZPS System is a non-locking, 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.

AI/ML Overview

This document is an FDA 510(k) premarket notification for the Zimmer Plates and Screws System (ZPS). It is a regulatory document and does not contain information about a study proving device acceptance criteria in the context of AI/software performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on material, design, and mechanical performance, which is typical for hardware medical devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set specifics, as these concepts are not applicable to this document.

The document primarily states:

Device Name: Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
Indications for Use: Temporary internal fixation and stabilization of various osteotomies and fractures (e.g., comminuted, supracondylar, extra-articular, osteopenic bone, nonunions, malunions). Smaller plates for hands and feet, calcaneal plates for calcaneus.
Comparison to Predicate Device: Similar in intended use, basic shape, compatible diameters, materials, and performance characteristics.
Performance Data:
- Non-Clinical Performance: Biocompatibility testing (per ISO 10993-1 and 21 CFR § 58) and beam bending cross-sectional analyses showing similar mechanical performance to predicate devices.
- Clinical Performance: "Clinical data and conclusions were not needed for these devices." This indicates that for this type of medical device (fixation plates and screws), the FDA often relies on non-clinical performance data and substantial equivalence to already approved predicate devices, rather than new clinical trials demonstrating "acceptance criteria" in the way one might for diagnostic or AI-driven devices.

Summary

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March 4. 2015

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

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

Re: K143331 Trade/Device Name: Zimmer Plates and Screws System (ZPS)-Non-sterile ZPS 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, HTN Dated: February 6, 2015 Received: February 9, 2015

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 (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 yours.

Mark N. Melkerson -S

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

Enclosure

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See PRA Statement below.

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

Indications for Use

510(k) Number (if known)

K143331

Device Name

Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS

Indications for Use (Describe)

ZPS One-Third Tubular Plates, T-Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloyerleaf and Spoon 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 ostectomies 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

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

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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a large, stylized blue letter "Z" enclosed in a blue circle. Below the circle is the word "zimmer" in a lowercase, sans-serif blue font.

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:	November 19, 2014
Trade Name:	Zimmer Plates and Screws System (ZPS) - Non-sterileZPS
Common Name:	Temporary Internal Fixation Devices
Classification Namesand References:	Single/multiple component metallic bone fixationappliances and accessories (21 CFR 888.3030, productcodes HRS and HTN) and Smooth or threaded metallicbone fastener (21 CFR 888.3040, product code HWC)
Classification Panel:	Orthopedics/87
Predicate Device(s):	ZPS 2.7mm L-Plate, 3.5mm One Third Tubular Plate,4.5mm T-Plate and 3.5 T Plate, (K140508, cleared August14, 2014), ZPS 4.5mm T-Plate (K143066, clearedNovember 28, 2014), and ZPS 3.5/4.5mm ContourableDual Compression Plates (K142836, cleared November12,2014)
Purpose and Device Description:	The ZPS System is a non-locking, stainless steel plate andscrew system. Plate shapes vary to address varying patientbone sizes and injury fragment sizes. Plates incorporate aspherical sliding slope plate hole design to achieve thecompression required to treat bone fractures. The platesare used with a variety of screws for temporary fixation tothe bone.

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Indications for Use:	ZPS One-Third Tubular Plates, T-Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloverleaf and Spoon 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 subject ZPS Plates are similar in intended use, basic shape, compatible diameters, materials and performance characteristics to their respective predicate devices. The subject devices are provided non-sterile.
Performance Data (Nonclinical and/or Clinical):
	Non-Clinical Performance and Conclusions: Biocompatibility - Biocompatibility testing on the ZPS Plate material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.Beam bending cross sectional analyses of the ZPS Plates and their respective predicate devices, the ZPS L-Plates, T-Plates, and One-Third Tubular Plates, resulted in similar mechanical performance. The subject and predicate devices are substantially equivalent.
	Clinical Performance and Conclusions: Clinical data and conclusions were not needed for

. 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.