The Orthofix Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and indicated for:

Degenerative disc disease (as defined as back pain of discogenic origin with degenerative a) disc confirmed by patient history and radiographic studies);
Spondylolisthesis; b)
Trauma (i.e., fracture or dislocation); c)
d) Spinal stenosis;
Deformities (i.e., scoliosis, kyphosis, and/or lordosis); e)
Tumor; f)
Pseudoarthrosis; g)
Revision of previous surgery h)

Device Description

The Orthofix Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) and Nitinol (per ASTM 2063) components that allow a surgeon to build a temporary anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices. The instrumentation provided to facilitate implantation are Class I, manual orthopedic standard surgical instruments.

AI/ML Overview

The Orthofix Anterior Cervical Plate System is a medical device that underwent non-clinical testing to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Standard / Test / FDA Guidance)	Reported Device Performance
Static Torsion Test	ASTM F1717-11	Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device, the Hallmark Anterior Cervical Plate System (K050892 and K100614), that have the same intended use, similar indications, technological characteristics, and principles of operation. (The document does not provide specific numerical results, but states that equivalence was met according to the standard.)
Static Axial Compression Bending Test	ASTM F1717-11	Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device, the Hallmark Anterior Cervical Plate System (K050892 and K100614), that have the same intended use, similar indications, technological characteristics, and principles of operation. (The document does not provide specific numerical results, but states that equivalence was met according to the standard.)
Dynamic Axial Compression Bending Test	ASTM F1717-11	Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device, the Hallmark Anterior Cervical Plate System (K050892 and K100614), that have the same intended use, similar indications, technological characteristics, and principles of operation. (The document does not provide specific numerical results, but states that equivalence was met according to the standard.)

2. Sample Size and Data Provenance:

The document describes non-clinical mechanical testing. The sample size for this type of testing is generally governed by the specific ASTM standard. The document does not explicitly state the sample size used for the tests.

Data Provenance: The testing was conducted to fulfill regulatory requirements for a 510(k) submission in the United States, indicating the tests were performed on physical device samples. It is not patient or human subject data, so concepts like "country of origin of the data" or "retrospective/prospective" do not apply in the typical sense for clinical studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable as the described study is a non-clinical mechanical performance study, not a study involving human experts establishing ground truth for a diagnostic or AI device. The "ground truth" here is compliance with the ASTM standard.

4. Adjudication Method for the Test Set:

This information is not applicable for a mechanical performance study. The evaluation is based on whether the physical testing results meet the defined parameters of the ASTM standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI, not for mechanical device performance.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance):

No, a standalone performance study was not done. This device is a physical implant, not a software algorithm that would have standalone performance.

7. Type of Ground Truth Used:

The ground truth used was adherence to the ASTM F1717-11 standard for "Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model." This standard defines the methodologies and expected performance characteristics for such devices.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is a mechanical device performance study, not an AI/machine learning model.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set involved in this mechanical performance study.

Summary

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JUL 200 2012

・・・

Orthofix Anterior Cervical Plate System

510(k) SUMMARY

Orthofix Anterior Cervical Plate System

Submitter Information

Name:Address:	Orthofix Inc.3451 Plano ParkwayLewisville, TX 75056
Telephone Number:Fax Number:Email:	214-937-2000214-937-3322alisonbaduel@orthofix.com
Registration Number:	3008524126
Contac Person:	Ally BaduelRegulatory Affairs Specialist
Date Prepared:	June 4, 2012
Name of Device
Trade Name/ProprietaryName:	Orthofix Anterior Cervical Plate System
Common Name:	anterior cervical plate system
Product Code:	KWQ - Appliance, Fixation, Spinal Intervertebral Body
Regulatory Classification:	Class II - 888.3060 - Spinal intervertebral body fixation orthosis
Review Panel:	Orthopedic Device Panel
Predicate Devices:	Hallmark Anterior Cervical Plate System (K050892 andK100614), DePuy/Codman & Shurtleff, Inc. SLIM LOCAnterior Cervical Plate System (K013877), Pioneer AspectAnterior Cervical Plate (K111528)

Reason for 510(k) Submission: New product offering

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Image /page/1/Picture/0 description: The image shows the logo for ORTHOFIX. The logo consists of a stylized symbol above the word "ORTHOFIX". The symbol is a geometric shape with curved lines, and the text is in a bold, sans-serif font. The logo is black and white.

Device Description

Intended Use / Indications for Use

The Orthofix Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and indicated for:

Degenerative disc disease (as defined as back pain of discogenic origin with degenerative a) disc confirmed by patient history and radiographic studies);
Spondylolisthesis; b)
Trauma (i.e., fracture or dislocation); c)
d) Spinal stenosis;
Deformities (i.e., scoliosis, kyphosis, and/or lordosis); e)
Tumor; f)
Pseudoarthrosis; g)
Revision of previous surgery h)

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Summary of Technological Characteristics of the Device Compared to the Selected Predicate Devices

Characteristic	SubjectDevice	Predicates
Device Name	OrthofixAnteriorCervical PlateSystem	Hallmark AnteriorCervical PlateSystem(K050892)	HallmarkAnteriorCervical PlateSystem(K100614)	DePuy/Codman& Shurtleff, Inc.(K013877)	Pioneer AspectAnteriorCervical Plate(K111528)
Method ofFixation	ACP systemintended foranterior fixationto the cervicalspine from C2to C7.	ACP systemintended foranterior fixationto the cervicalspine from C2 toC7.	ACP systemintended foranterior fixationto the cervicalspine from C2 toC7.	ACP systemintended foranterior fixationto the cervicalspine from C2 toC7.	ACP systemintended foranterior cervicalfixation.
Implantation	Anteriorapproach	Anterior approach	Anteriorapproach	Anterior approach	Anteriorapproach
Design	Plates (1-levelthrough 5-level)	Plates (1-levelthrough 4-level)	Plates (5-levelplate only)	Plates (1-levelthrough 5-level)	Plates (1-levelthrough 4-level)
Material	Ti6Al4V ELIper ASTMF136 andNitinol perASTM F2063.	Ti6Al4V ELI perASTM F136.	Ti6Al4V ELI perASTM F136.	Titanium	Ti6Al4V ELIper ASTMF136 andNitinol perASTM F2063.

PERFORMANCE DATA-Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

Characteristic	Standard / Test/ FDA Guidance
Static Torsion Test	ASTM F1717-11
Static Axial Compression Bending Test	ASTM F1717-11
Dynamic Axial Compression Bending Test	ASTM F1717-11

Performance Data Summary

Mechanical testing for the subject Orthofix Anterior Cervical Plate System was conducted in accordance to ASTM F1717-11- Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model. Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device the Hallmark Anterior Cervical Plate System

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(K050892 and K100614) that have the same intended use, similar indications, technological characteristics, and principles of operation.

Basis of Substantial Equivalence

The subject Orthofix Anterior Cervical Plate System is substantially equivalent in design, configuration, function, indications for use to the Hallmark Anterior Cervical Plate System (K050892 & K100614), the DePuy/Codman & Shurtleff, Inc. Anterior Cervical Plate System (K013877), and the Pioneer Aspect Anterior Cervical Plate (K111528).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

Orthofix, Incorporated % Ms. Ally Baduel Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

JUL 20 2012

Re: K121658

Trade/Device Name: Orthofix Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 4, 2012 Received: June 5, 2012

Dear Ms. Baduel:

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

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Page 2-Ms. Ally Baduel

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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,

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

Enclosure

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Indications for Use

510(k) Number (if known):

K12-1658

Device Name: Orthofix Anterior Cervical Plate System

Indications for Use:

The Orthofix Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for:

a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
Spondylolisthesis; b)
c) Trauma (i.e., fracture or dislocation);
d) Spinal stenosis;
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
Tumor; f)
g) Pseudoarthrosis;
h) Revision of previous surgery

Prescription Use: X (Part 21 CFR 801 Subpart D) And/Or

Over-The-Counter (Part 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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

K121658 510(k) Number_

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.