K Number
K012305
Device Name
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
Manufacturer
Date Cleared
2001-08-22

(30 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trinica™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels 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 of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
Device Description
The Trinica Anterior Cervical Plate System is a fixation device consisting of cervical plates, locking caps, fixed bone screws and variable angle bone screws made from titanium alloy in conformance with ASTM F136. The locking cap is preassembled onto the plate and is designed with tabs that prevent bone screws from backing out. The plates and locking caps are treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter. Plates are offered in one-level, two-level, three-level, and four-level fusion configurations (24 mm through 92 mm). Bone screws are available in lengths from 10mm through 18mm in 1mm increments. The screws have either a 4.2 inch 4.6 inch diameter. Fixed angle and variable angle screws are available.
More Information

No
The 510(k) summary describes a mechanical implant (anterior cervical plate system) made of titanium alloy. There is no mention of software, image processing, AI, ML, or any data-driven components. The performance studies focus on mechanical testing and risk analysis related to the physical device.

No.

Explanation: This device is a fixation device intended for temporary stabilization during spinal fusions, not a therapeutic device that directly treats a condition.

No

This device is described as a fixation device (cervical plate system) used for spinal fusion, not for diagnosing medical conditions. Its purpose is to stabilize the spine, not to identify or assess diseases.

No

The device description explicitly states it is a "fixation device consisting of cervical plates, locking caps, fixed bone screws and variable angle bone screws made from titanium alloy," which are physical hardware components.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description and Intended Use: The provided information clearly describes a surgical implant used for stabilizing the cervical spine during fusion procedures. It is a physical device implanted into the body, not a test performed on a sample outside the body.

The description focuses on the materials, design, and surgical application of the device, which are characteristic of a surgical implant, not an IVD.

N/A

Intended Use / Indications for Use

The Trinica™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels 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 of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Product codes

KWQ

Device Description

The Trinica Anterior Cervical Plate System is a fixation device consisting of cervical plates, locking caps, fixed bone screws and variable angle bone screws made from titanium alloy in conformance with ASTM F136. The locking cap is preassembled onto the plate and is designed with tabs that prevent bone screws from backing out. The plates and locking caps are treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter

Plates are offered in one-level, two-level, three-level, and four-level fusion configurations (24 mm through 92 mm). Bone screws are available in lengths from 10mm through 18mm in 1mm increments. The screws have either a 4.2 inch 4.6 inch diameter. Fixed angle and variable angle screws are available.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cervical spine at levels C2-T1

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Based on risk analysis, appropriate testing was conducted to evaluate the impact of the changes to ensure that the modified device meets established criteria and that identified potential risks were mitigated. Results of the testing demonstrated that the modified device meets established criteria.

Testing of the Trinica Anterior Cervical Plate System demonstrates that the device is substantially equivalent to the predicate Michelson Anterior Cervical Plate System (K974435) and that the design modifications do not affect device safety and effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Michelson Anterior Cervical Plate K974435

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

K0/2305

AUG 2 2 2001

510(k) Summary

Submitter's Information

Date:

Name/Address:

Telephone Number: Fax Number:

July 20, 2001

Sulzer Spine-Tech 7375 Bush Lake Road Minneapolis, Minnesota 55439

(952) 830-6205

(952) 832-5620

Janell A. Colley Senior Regulatory Affairs Specialist

Device Information

Trade Name:

Contact:

Trinica™ Anterior Cervical Plate System

Spinal Intervertebral Body Fixation

Common Name: Orthosis

Classification:

Predicate Device:

Class II, KWQ

Michelson Anterior Cervical Plate K974435 concurrence date February 19, 1998

Device Description:

The Trinica Anterior Cervical Plate System is a fixation device consisting of cervical plates, locking caps, fixed bone screws and variable angle bone screws made from titanium alloy in conformance with ASTM F136. The locking cap is preassembled onto the plate and is designed with tabs that prevent bone screws from backing out. The plates and locking caps are treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter

Plates are offered in one-level, two-level, three-level, and four-level fusion configurations (24 mm through 92 mm). Bone screws are available in lengths from 10mm through 18mm in 1mm increments. The screws have either a 4.2 inch 4.6 inch diameter. Fixed angle and variable angle screws are available.

1

Intended Use:

The Trinica Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels 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 of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Comparison of Required Technological Characteristics

The Trinica Anterior Cervical Plate System is substantially equivalent to the predicate Michelson Anterior Cervical Plate System (K974435). The table below provides a comparison of equivalency characteristics.

CharacteristicsEquivalency
Intended UseIdentical
Anatomical SitesIdentical
Target PopulationIdentical
SterilizationIdentical
PackagingIdentical
Operating PrincipleIdentical
MaterialsIdentical
LabelingSubstantially Equivalent
Physical Characteristics (Design)Substantially Equivalent
Performance TestingSubstantially Equivalent
Safety CharacteristicsSubstantially Equivalent

Summary of Non-Clinical Tests

Based on risk analysis, appropriate testing was conducted to evaluate the impact of the changes to ensure that the modified device meets established criteria and that identified potential risks were mitigated. Results of the testing demonstrated that the modified device meets established criteria.

Conclusions Drawn From Testing

Testing of the Trinica Anterior Cervical Plate System demonstrates that the device is substantially equivalent to the predicate Michelson Anterior Cervical Plate System (K974435) and that the design modifications do not affect device safety and effectiveness.

2

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2001

Ms. Janell A. Colley Senior Regulatory Affairs Specialist Sulzer Spine-Tech 7375 Bush Lake Road Minneapolis, MN 55439-2027

Re: 510(K) Number K012305 Trade/Device Name: Trinica™ Anterior Cervical Plate System Regulation Number: 21 CFR § 888.3060 Regulatory Class: II Product Code: KWQ Dated: July 20, 2001 Received: July 23, 2001

Dear Ms. Colley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

3

Page 2 - Ms. Janell A. Colley

This letter will allow you to begin marketing your device as described in your 510(k) This iction will anow you to oogin made of substantial equivalence of your device to a premiarket notification: - The PDF 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 and If you desire specific advice to: your cetic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your at (501) 594-4097. Tractionally, et Compliance at (301) 594-4639. Also, please note the device, prease contact the online by reference to premarket notification" (21CFR 807.97). Itegulation chitica, "Misolanding of responsibilities under the Act may be obtained from the Onlici general information of the statunce at its toll-free number (800) 638-2041 or (301) Division of Sinall Marianaolaaress "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

R. Mark M. Melleuson

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

Enclosure

4

Indications for Use Statement

510(K) Number:

Device Name: Trinica™ Anterior Cervical Plate System

Indications for Use:

The Trinica™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels 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 of the disc 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: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Milkerson

on Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K012305

OR Over-

Prescription Use _____________________________________________________________________________________________________________________________________________________________

the-Counter-Use (Per 21 CFR 801.109)