The Trinica and Trinica® Select Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at level C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.

WARNING: These devices are not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The Trinica® and Trinica® Select Anterior Cervical Plate Systems both consist of cervical plates, locking caps, bone screws, and the instruments necessary to implant the specific system. All implant components are made from a titanium alloy (Ti-6Al-4V). Both, the Trinica® Select Anterior Cervical Plate Systems, are intended to provide stabilization of the cervical vertebra for various indications (see below). The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and/or self-drilling bone screws using an anterior surgical approach. Bone screws are available for fixed angle or variable angle implantation. The Trinica® and Trinica® Select Anterior Cervical Plate Systems are provided non-sterile, are for single use only and are intended to be removed after solid fusion has occurred.

The only difference between the two systems is the Trinica® Select system has smaller width cervical plates to accommodate smaller anatomical structures. The locking cap for the Trinica® Select system required a reduction to diameter and height to accommodate reduced lateral profile cervical plate.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Zimmer Spine Trinica® and Trinica® Select Anterior Cervical Plate Systems:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format typical for AI/software devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various tests. The performance is reported in terms of meeting the intended use and being comparable to the predicates.

Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance
Mechanical Performance: Demonstrate equivalent mechanical properties to predicate devices for intended stabilization.	- Bench testing (static compression bending, dynamic compression bending, static torsion per ASTM F1717) was performed. - Conclusion: "confirmed the product performance of current Trinica and Trinica Select is suitable for its intended use: the same intended use as the predicate devices."
Functional Performance: Demonstrate that the system can be implanted and functions as intended.	- Cadaver lab testing of the implants and instruments was performed. - Conclusion: "demonstrates that the system meets the defined intended use(s) and functions as intended."
Biocompatibility: Ensure materials are biocompatible after manufacturing and minor design changes.	- Biocompatibility testing was performed. - Conclusion: "ensured the current Trinica and Trinica Select instrument materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices."
Sterilization, Dry Time & Cleaning: Ensure steam sterilization, cleaning, and dry time instructions are substantially equivalent.	- Sterilization, Dry Time and Cleaning testing was performed. - Conclusion: "ensured the current Trinica and Trinica Select systems steam sterilization, cleaning and dry time instructions are substantially equivalent to the predicate devices."
Intended Use: Maintain the same indicated uses as the predicate devices.	- Stated: "The current Trinical and Trinical Select Anterior Cervical Plate Systems performance, intended use and fundamental scientific technology remain unchanged from their predicate devices."
Fundamental Scientific Technology: Maintain identical underlying technology for spinal intervertebral body fixation.	- Stated: "The current Trinical and Trinical Select Anterior Cervical Plate Systems performance, intended use and fundamental scientific technology remain unchanged from their predicate devices."
Device Design: Maintain equivalent design for anterior cervical plate stabilization.	- Stated: "The modifications do not change the stabilization fixation of the cervical vertebra when compared to the predicate devices." (Referring to the minor modification of Trinica Select's width and locking cap).
Materials: Use identical materials (Titanium Alloy Ti-6Al-4V) for implants and similar treatments for plates/locking caps.	- Confirmed: Identical "Titanium Alloy (Ti-6Al-4V)" for implants and "Treated: Titanium Anodization per AMS 2488 Type II" for plates and locking caps.
Packaging: Provided non-sterile for system, sterile for drill bits/fixation pins.	- Confirmed: Identical "Provided Non-Sterile" for implants and instruments, and "Provided Sterile" for drill bits and fixation pins.
Sterilization Parameters (for user): Establish appropriate steam sterilization cycle. (Note: A difference in cycle time was deemed acceptable for substantial equivalence).	- New Device: "Steam Sterilization Cycle Time: 4 Minutes Temp: 270°F (132°C)" - Predicate Device: "Steam Sterilization Cycle Time: 15 Minutes Temp: 270°F (132°C)" - Comparison: "Similar" (implies the new cycle was validated and found acceptable).

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

Sample Size: Not explicitly stated for specific test sets (e.g., how many plates were bent, how many cadavers were used). The document refers to "components" and "implants and instruments" being tested.
Data Provenance: Not specified. This is a premarket notification for a medical device (spinal fixation system), not an AI/software device, so the concept of "country of origin of data" or "retrospective/prospective" in the context of clinical trials doesn't directly apply here. The testing is bench and cadaver-based, not patient data.

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

This information is not applicable to the type of device and testing described. The "ground truth" for mechanical and functional performance is established through established engineering standards (ASTM F1717) and cadaveric testing, not through expert consensus on medical images or clinical outcomes.

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

This information is not applicable. The tests performed are objective engineering and biological assessments, not subjective interpretations 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:

This is not applicable. This document describes a spinal fixation system (physical implant), not an AI-powered diagnostic or assistive tool.

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

This is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is based on:
- Engineering Standards: ASTM F1717 for mechanical testing.
- Functional Assessment: Successful implantation and function in cadaveric models.
- Biological Compatibility Standards: Biocompatibility testing to established norms.
- Sterilization Validation Standards: Testing to confirm effective sterilization, cleaning, and dry times.

8. The sample size for the training set:

This is not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."

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

This is not applicable as there is no training set for this type of device.

In summary:

This 510(k) summary is for a physical medical device (anterior cervical plate system), not an AI/software device. Therefore, many of the requested points, especially those related to AI model evaluation (sample sizes for test/training sets, experts, adjudication, MRMC studies, standalone performance, types of ground truth for AI), are not relevant to this document. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to previously cleared predicate devices through direct comparison of specifications and various non-clinical (bench and cadaver) performance tests.

Summary

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zimmer spine	510(k) SUMMARYZimmer SpineTrinica ® and Trinica ® SelectAnterior Cervical Plate Systems
----------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------

Date of Summary Preparation:	August 27, 2013
Submitter:	Zimmer Spine, Inc.7375 Bush Lake RoadMinneapolis, MN 55439USA
Establishment Registration Number:	2184052 (Minneapolis)
Company Contact:	Jonathan GilbertRegulatory Affairs DirectorEmail: Jonathan.Gilbert@Zimmer.comOffice: 952.830.6385Fax: 952.837.6985
Trade Name(s):	Trinica ® Anterior Cervical Plate SystemTrinica ® Select Anterior Cervical Plate System
Device Name (Common Name):	Spinal Fixation System
Device Classification:	Class II
Product Code(s):	KWQ
Regulation Number:	21 CFR § 888.3060
Regulation Description:	Spinal Intervertebral Body Fixation Orthosis

Predicate Devices:

For clarification purposes, this is the initial submission for this device modification and has not been previously submitted/withdrawn via a 510(k), PMA or de novo pathway. The current Trinica® Select Anterior Cervical Plate System is claimed to be substantially equivalent to the following legally marketed predicate devices:

Trinica®Predicate Device Name	Submission IDNumber	Clearance Date
Trinica®Anterior Cervical Plate System	K012305	August 22, 2001
Trinica® SelectPredicate Device Name	Submission IDNumber	Clearance Date
Trinica® SelectAnterior Cervical Plate System	K022344	September 24, 2002
Trinica®Anterior Cervical Plate System	K012305	August 22, 2001

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General Device Description:

Indications for Use:

The Trinical and Trinical Select Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at level C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (defined as kyphosis, lordosis or scollosis), pseudoarthrosis and/or failed previous fusions.

WARNING: These devices are not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Summary of Technological Characteristics:

The current Trinical and Trinical Select Anterior Cervical Plate Systems share technological characteristics to their cleared predicate devices as described in K012305 and K022344, Trinica and Trinical Select Anterior Cervical Plate Systems. The characteristics include the same general design, same materials, same range of sizes, substantially equivalent performance characteristics and the same intended use.

The current and predicate Trinica Select Anterior Cervical Plate Systems both consist of cervical plates, locking caps, bone screws, and the instruments necessary to implant the specific system. All implant components are made from a titanium alloy (Ti-6AI-4V).

The current and predicate Trinica® Select Anterior Cervical Plate Systems are intended to provide stabilization of the cervical vertebra for various indications for use, as stated in the section above. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and/or self-drilling bone screw using an anterior surgical approach. Bone screws are available for fixed angle or variable angle implantation. The current and predicate Trinica® and Trinica® Select Anterior Cervical Plate Systems are provided non-sterile, are for single use only and are intended to be removed after solid fusion has occurred.

Summary of Performance Testing:

The non-clinical testing included components of the current Trinica® Select Anterior Cervical Plate Systems, which were reviewed and tested appropriately for design design validation, biocompatibility and sterilization. The test results conclude the current Trinica® Select Anterior Cervical Plate Systems to be substantially equivalent to their predicate devices, Trinica® and Trinica® Select Anterior Cervical Plate Systems.

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Bench testing (static compression bending, dynamic compression bending, and static . torsion testing per ASTM F1717) was performed for the subject device and confirmed the product performance of current Trinica and Trinica Select is suitable for its intended use: the same intended use as the predicate devices.
Cadaver lab testing of the current Trinica and Trinica Select implants and instruments . demonstrates that the system meets the defined intended use(s) and functions as intended.
. Biocompatibility testing ensured the current Trinica and Trinica Select instrument materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices.
. Sterilization, Dry Time and Cleaning testing ensured the current Trinica and Trinica Select systems steam sterilization, cleaning and dry time instructions are substantially equivalent to the predicate devices.

The current Trinica® and Trinica® Select Anterior Cervical Plate Systems performance, intended use and fundamental scientific technology remain unchanged from their predicate devices. The modifications do not change the stabilization fixation of the cervical vertebra when compared to the predicate devices. Trinica and Trinica Select as described in K012305 and K022344. The fixation element consists of a cervical plate that is attached to the vertebral body of the cervical spine using an anterior approach. The plate implant, with seff-tapping and/or self-drilling bone screw, is intended to be removed after solid fusion has occurred.

Substantial Equivalence:

Zimmer Spine considers the current Trinica® and Trinica® Select Anterior Cervical Plate Systems product performance to be substantially equivalent to their predicate device, Trinica and Trinica Select as described in K012305 and K022344 because there are no changes to the product performance specifications; device intended use, or device functional scientific technology. The table below provides a substantial equivalence summary:

ProductCharacteristics	Current DevicesTrinica andTrinica Select	Predicate DevicesTrinica andTrinica Select	Compare
Device Name(s)	Trinica®Anterior Cervical PlateSystemTrinica® SelectAnterior Cervical PlateSystem	Trinica®Anterior Cervical PlateSystemTrinica® SelectAnterior Cervical PlateSystem	Identical
	Product Code	KWQ	KWQ
ProductClassification	Spinal Intervertebral BodyFixation Orthosis	Spinal Intervertebral BodyFixation Orthosis	Identical
Class	Class IIFDA 21 CFR§ 888.3060	Class IIFDA 21 CFR§ 888.3060	Identical
IndicationsFor Use	The Trinica® and Trinica®Select Anterior Cervical PlateSystem is intended foranterior interbody screwfixation of the cervical spine atlevel C2-T1. The system isindicated for use in thetemporary stabilization of theanterior spine during thedevelopment of cervical spinalfusions in patients with	The Trinica® and Trinica®Select Anterior Cervical PlateSystem is intended foranterior interbody screwfixation of the cervical spine atlevel C2-T1. The system isindicated for use in thetemporary stabilization of theanterior spine during thedevelopment of cervical spinalfusions in patients with	Identical
ProductCharacteristics	Current DevicesTrinica andTrinica Select	Predicate DevicesTrinica andTrinica Select	Compare
	degenerative disc disease (asdefined by neck pain ofdiscogenic origin confirmed bypatient history andradiographic studies), trauma(including fractures), tumors,deformity (defined askyphosis, lordosis orscoliosis), pseudoarthrosisand/or failed previous fusions.WARNING: These devicesare not approved for screwattachment to the posteriorelements (pedicles) of thecervical, thoracic, or lumbarspine.	degenerative disc disease (asdefined by neck pain ofdiscogenic origin confirmed bypatient history andradiographic studies), trauma(including fractures), tumors,deformity (defined askyphosis, lordosis orscoliosis), pseudoarthrosisand/or failed previous fusions.WARNING: These devicesare not approved for screwattachment to the posteriorelements (pedicles) of thecervical, thoracic, or lumbarspine.
Device design	Anterior Cervical PlateSystem intended to providestabilization of the cervicalvertebra for variousindications (see above).	Anterior Cervical PlateSystem intended to providestabilization of the cervicalvertebra for variousindications (see above).	Identical
FundamentalTechnology	Spinal intervertebral bodyfixation orthosis	Spinal intervertebral bodyfixation orthosis	Identical
Surgical Procedure	Anterior surgical approach	Anterior surgical approach	Identical
Instrumentation	Available(Instruments Added)	Available	Similar
Materials -Implants	Titanium Alloy(Ti-6Al-4V)	Titanium Alloy(Ti-6Al-4V)	Identical
Materials -Plates and LockingCaps	Treated: Titanium Anodizationper AMS (Aerospace MaterialSpecification) 2488 Type II.	Treated: Titanium Anodizationper AMS (Aerospace MaterialSpecification) 2488 Type II.	Identical
SystemPackaging -Implants andInstruments	Provided Non-Sterile	Provided Non-Sterile	Identical
Drill Bits andFixation Pins	Provided Sterile	Provided Sterile	Identical
Sterilization	Steam SterilizationCycle Time: 4 MinutesTemp: 270°F (132°C)	Steam SterilizationCycle Time: 15 MinutesTemp: 270°F (132°C)	Similar

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three wing-like shapes stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.

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

August 29, 2013

Zimmer Spine, Incorporated Mr. Jonathan Gilbert Regulatory Affairs Director 7375 Bush Lake Road Minneapolis, Minnesota 55439

Re: K132012

Trade/Device Name: Trinica Anterior Cervical Plate Systems Trinica® Select Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 28, 2013 Received: July 1, 2013

Dear Mr. Gilbert:

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 r 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 or my 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

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Page 2 - Mr. Jonathan Gilbert

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Erin I. Keith

For

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

Enclosure

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Zimmer Spine - 510(k) - Trinica and Trinica Select - Section 4. Indications for Use

4. INDICATIONS FOR USE STATEMENT

K132012 510(k) Number (if known)

Trinica® Anterior Cervical Plate Systems
Trinica® Select Anterior Cervical Plate System Device Name(s):

Indications for Use

WARNING: These devices are not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.