ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, L-Buttress Plates, Cobra 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 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. The purpose of this submission is a line extension adding the sterile version of the 2.7mm cortical screws cleared under K143066.

AI/ML Overview

This document describes the 510(k) premarket notification for the Zimmer Plates and Screws System (ZPS) - Sterile 2.7mm Cortical Screws. The submission is a line extension to add a sterile version of screws that were previously cleared as non-sterile. Therefore, the focus is on demonstrating that the sterile version is substantially equivalent to the predicate devices, primarily through non-clinical performance data related to sterility and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Biocompatibility	Full biocompatibility testing on the screw material performed per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
Sterility & Shelf Life (for sterile components)	Shelf life validation performed based on FDA recognized consensus standards ISO 11607-1:2006 and 11607-2:2006. The implants supplied sterile have a 10-year shelf life.
Mechanical Performance	No additional mechanical testing was performed. The rationale is that the sterile 2.7mm ZPS screws are identical in design and materials (except for sterility) to the non-sterile screws cleared under K143066 and the sterile version cleared under K063303.
Substantial Equivalence (Overall)	The subject ZPS screws are identical in intended use, basic shape, compatible diameters, materials, and performance characteristics to their respective predicate devices, with the exception that the subject screws will be provided sterile.

2. Sample size used for the test set and the data provenance
The document does not explicitly state a "test set" in the context of a clinical performance study with a specific sample size. The evaluation is primarily based on non-clinical testing and comparison to predicate devices, where the "test set" would refer to samples used in biocompatibility and shelf-life testing. The data provenance is from Zimmer, Inc.'s internal testing and regulatory submission processes (e.g., test reports for biocompatibility and shelf-life).

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)
This information is not applicable. The device is a bone fixation fastener, not an AI/imaging device requiring expert interpretation for ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is a non-clinical evaluation of a physical surgical device, not a diagnostic or prognostic system requiring expert 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 or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is established through recognized standards and testing methods for medical device performance and safety:

Biocompatibility: Adherence to ISO 10993-1 and Good Laboratory Practices (21 CFR 58), with "passed" results indicating acceptable biological response.
Sterility and Shelf Life: Adherence to ISO 11607-1:2006 and 11607-2:2006, with "10-year shelf life" indicating validated performance.
Mechanical Equivalence: Demonstrated identity in design and material to mechanically tested and cleared predicate devices.

8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI models with a "training set."

9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.

Summary

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

November 24, 2015

Zimmer, Incorporated Ms. Dorothy Snyder Associate Director, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K152841

Trade/Device Name: Zimmer Plates and Screws System (ZPS) - Sterile 2.7mm Cortical Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 28, 2015 Received: September 29, 2015

Dear Ms. Snyder:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/ResourcesforYou/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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

Indications for Use

510(k) Number (if known)

Device Name

Zimmer Plates and Screws System (ZPS) - Sterile 2.7mm Cortical Screws

Indications for Use (Describe)

ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloverleaf and Spoon Plates are indicated for temporary internal fixation 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)

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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, the word "zimmer" is written in lowercase, using the same blue color as the "Z" and circle.

510(k) Summary

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Dorothy SnyderAssociate Director, Trauma Regulatory AffairsTelephone: (574) 372-4092Fax: (574) 372-4605
Date:	November 16, 2015
Trade Name:	Zimmer® Plates and Screws (ZPS) Sterile 2.7mm CorticalScrew
Common Name:	Temporary Internal Fixation Devices
Classification Namesand References:	Smooth or threaded metallic bone fixation fastener (21CFR 888.3040, HWC)
Classification Panel:	Orthopedics/87
Predicate Device(s):	Zimmer® Plates and Screws, Non-sterile 2.7mm corticalscrews cleared under K143066 on November 28, 2014.Zimmer Plates and Screws System (ZPS) – Non-sterileZPS cleared under K143331 on March 04, 2015Reference Predicate Only:Universal Locking System, Sterile 2.7mm cortical screwscleared under K063303 on November 22, 2006.
Purpose and Device Description	The purpose of this submission is a line extension addingthe sterile version of the 2.7mm cortical screws clearedunder K143066.
	System DescriptionThe Zimmer Plates and Screws System (ZPS) is anonlocking, stainless steel plate and screw system. Plate
	shapes 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 theforces/load over a larger area when used for non-plate,bone fragment, and fracture fixation
Intended Use:	ZPS One-Third Tubular Plates, One-Quarter TubularPlates, T-Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, ReconstructionPlates, Contourable Dual Compression Plates, Cloverleafand Spoon Plates are indicated for temporary internalfixation 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 andsmall fragments of the hands and feet.
	ZPS Calcaneal plates are indicated for temporary internalfixation and stabilization of osteotomies and fractures ofthe calcaneus.
	ZPS and Forte Screws are temporary internal fixationdevices designed to stabilize fractures during the normalhealing process.
Comparison to Predicate Device:	The subject ZPS screws are identical in intended use, basicshape, compatible diameters, materials and performancecharacteristics to their respective predicate devices, withexception that the subject screws will be provided sterile.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:
	• Shelf Life - The implants that are supplied sterile havea 10 year shelf life. Zimmer performs shelf life testingbased on FDA recognized consensus standards ISO11607-1:2006 and 11607-2:2006.

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. Biocompatibility – Biocompatibility testing on the screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
Performance Evaluation Because the sterile 2.7mm • ZPS screws are identical to the sterile version cleared under K063303 and identical (with exception to sterility) to those non-sterile screws cleared K143066, no additional mechanical testing was performed.

Clinical Performance and Conclusions:

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

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.