LogoFDA 510(k) Search
K Number
K121658
Device Name
ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
Manufacturer
ORTHOFIX INC.
Date Cleared
2012-07-20

(45 days)

Product Code
KWQ
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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)
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.
More Information

K050892, K100614, K013877, K111528

Not Found

No
The device description and performance studies focus on mechanical properties and surgical instrumentation, with no mention of AI or ML.

No
The device is a temporary implant used for anterior fixation to the cervical spine, designed to provide structural support rather than directly treat or mitigate a disease.

No

Justification: The device is an implant for cervical spine fixation, not a tool for diagnosing medical conditions.

No

The device description explicitly states it is comprised of physical components made of titanium alloy and Nitinol, including screws, plates, and instrumentation. This indicates it is a hardware-based medical device, not software-only.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The intended use clearly describes a temporary implant for anterior fixation to the cervical spine for various spinal conditions. This is a surgical implant, not a diagnostic test performed on samples outside the body.
  • Device Description: The device is described as a system of titanium alloy and Nitinol components (screws, plates, instrumentation) used for surgical implantation. This aligns with a surgical device, not an IVD.
  • Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in these samples
    • Providing information for diagnosis, monitoring, or screening

The device is a surgical implant used to treat spinal conditions, not to diagnose them.

N/A

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)

Product codes (comma separated list FDA assigned to the subject device)

KWQ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cervical spine from C2 to C7

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)

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

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Hallmark Anterior Cervical Plate System (K050892 and K100614), DePuy/Codman & Shurtleff, Inc. SLIM LOC Anterior Cervical Plate System (K013877), Pioneer Aspect Anterior Cervical Plate (K111528)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

Image /page/0/Picture/0 description: The image shows the Orthofix logo and the number K121658. The Orthofix logo is a stylized image of a circle with a curved line running through it. The word "ORTHOFIX" is written in bold letters below the logo. The number K121658 is written in black ink in the upper left corner of the image.

JUL 200 2012

・・・

Orthofix Anterior Cervical Plate System

510(k) SUMMARY

Orthofix Anterior Cervical Plate System

Submitter Information

| Name:
Address: | Orthofix Inc.
3451 Plano Parkway
Lewisville, TX 75056 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Fax Number:
Email: | 214-937-2000
214-937-3322
alisonbaduel@orthofix.com |
| Registration Number: | 3008524126 |
| Contac Person: | Ally Baduel
Regulatory Affairs Specialist |
| Date Prepared: | June 4, 2012 |
| Name of Device | |
| Trade Name/Proprietary
Name: | 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 and
K100614), DePuy/Codman & Shurtleff, Inc. SLIM LOC
Anterior Cervical Plate System (K013877), Pioneer Aspect
Anterior Cervical Plate (K111528) |

Reason for 510(k) Submission: New product offering

  1. lofy

1

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

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.

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)

2

Image /page/2/Picture/0 description: The image shows the text "KI21658" at the top, followed by the Orthofix logo. The Orthofix logo consists of a stylized black bird above the word "ORTHOFIX" in a bold, sans-serif font. The logo is centered in the image.

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

| Characteristic | Subject
Device | Predicates | | | |
|-----------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Device Name | Orthofix
Anterior
Cervical Plate
System | Hallmark Anterior
Cervical Plate
System
(K050892) | Hallmark
Anterior
Cervical Plate
System
(K100614) | DePuy/Codman
& Shurtleff, Inc.
(K013877) | Pioneer Aspect
Anterior
Cervical Plate
(K111528) |
| Method of
Fixation | ACP system
intended for
anterior fixation
to the cervical
spine from C2
to C7. | ACP system
intended for
anterior fixation
to the cervical
spine from C2 to
C7. | ACP system
intended for
anterior fixation
to the cervical
spine from C2 to
C7. | ACP system
intended for
anterior fixation
to the cervical
spine from C2 to
C7. | ACP system
intended for
anterior cervical
fixation. |
| Implantation | Anterior
approach | Anterior approach | Anterior
approach | Anterior approach | Anterior
approach |
| Design | Plates (1-level
through 5-
level) | Plates (1-level
through 4-level) | Plates (5-level
plate only) | Plates (1-level
through 5-level) | Plates (1-level
through 4-level) |
| Material | Ti6Al4V ELI
per ASTM
F136 and
Nitinol per
ASTM F2063. | Ti6Al4V ELI per
ASTM F136. | Ti6Al4V ELI per
ASTM F136. | Titanium | Ti6Al4V ELI
per ASTM
F136 and
Nitinol per
ASTM F2063. |

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

CharacteristicStandard / Test/ FDA Guidance
Static Torsion TestASTM F1717-11
Static Axial Compression Bending TestASTM F1717-11
Dynamic Axial Compression Bending TestASTM 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

3

Image /page/3/Picture/0 description: The image shows the number "K121658" written in black ink in the upper left corner. To the right and below the number is the Orthofix logo. The logo consists of a stylized black circle with a white crescent shape inside, and the word "ORTHOFIX" in bold black letters below the circle.

(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).

4.fy

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract shapes that resemble human figures or waves, stacked on top of each other.

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

5

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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Image /page/6/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a stylized black symbol above the word "ORTHOFIX" in bold, black letters. The symbol is an abstract shape, possibly representing a bone or joint, and the word "ORTHOFIX" is written in a sans-serif font.

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

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K121658 510(k) Number_