(85 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and design of a physical implant (plate and screws) for spinal fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for anterior fixation to the cervical spine from C2 to C7 for various clinical indications, including degenerative disc disease, fracture, and spinal stenosis, all of which are conditions that benefit from therapeutic intervention.
No
The device, the CETRA Anterior Cervical Plate System, is an implant for anterior fixation to the cervical spine. Its intended use is to treat various spinal conditions, and the description explicitly states it consists of plates and screws for temporary implantation. There is no mention of it being used to diagnose conditions; instead, it is a treatment device.
No
The device description explicitly states it consists of physical components (plates and screws made of titanium alloy) and is intended for surgical implantation.
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 (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The CETRA Anterior Cervical Plate System is described as a system of plates and screws made of titanium alloy. These are physical implants intended for surgical fixation within the body.
- Intended Use: The intended use is for anterior fixation to the cervical spine. This is a surgical procedure performed on the patient's body.
The information provided clearly indicates that this device is a surgical implant used directly on the patient's anatomy, not a diagnostic tool used on samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The CETRA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spondylolisthesis;
c) Fracture;
d) Spinal Stenosis;
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
f) Tumor;
g) Pseudoarthrosis;
h) Revision of previous surgery
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The CETRA Anterior Cervical Plate System consists of an assortment of non- sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) plates and screws that allow a surgeon to build a temporary anterior cervical implant construct. The plate is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine.
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 consisting of Static Axial Compression Test, Dynamic Axial Compression Test and Static Torsion Test were conducted in accordance to ASTM F1717. Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
Additional mechanical testing included a screw push-out test, which served to mechanically evaluate the CETRA Anterior Cervical Plate System locking mechanism's ability to retain screws after being implanted.
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.
K100614, K030595, K013877, K133518
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2016
Orthofix, Inc. Jacki Koch Regulatory Affairs Specialist, II 3451 Plano Parkway Lewisville, Texas 75056
Re: K162638
Trade/Device Name: CETRA 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: December 6, 2016 Received: December 7, 2016
Dear Ms. Koch:
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 devicerelated 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.
1
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" (21 CFR 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,
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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| 510(k) Number (if known) | K162638 |
|---|---|
| Device Name | CETRA Anterior Cervical Plate System |
Indications for Use
Indications for Use (Describe)
The CETRA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spondylolisthesis;
c) Fracture;
d) Spinal Stenosis;
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
f) Tumor;
g) Pseudoarthrosis;
h) Revision of previous surgery
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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FORM FDA 3881 (8/14) Page 1 of 1
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Image /page/3/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue, stylized, abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. The "R" in "ORTHOFIX" is slightly larger than the other letters. There is a trademark symbol after the "X".
K162638 CETRA Anterior Cervical Plate System
510(k) SUMMARY
CETRA Anterior Cervical Plate System
| 510(k) Owner Information
Name:
Address: | Orthofix Inc.
3451 Plano Parkway
Lewisville, TX 75056 |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Fax Number:
Email: | 214.937.2100
214-937-3322
jackikoch@orthofix.com |
| Registration Number: | 2183449 |
| Contact Person: | Jacki Koch, Regulatory Affairs Specialist, II |
| Date Prepared: | September 21, 2016 |
| Name of Device
Trade Name / Proprietary
Name: | CETRA Anterior Cervical Plate System |
| Common Name: | Anterior Cervical Plate System |
| Product Code: | KWQ |
| Regulatory Classification: | Class II - 21 CFR § 888.3060 |
| Review Panel: | Orthopedic Device Panel |
| Primary Predicate: | Hallmark Anterior Cervical Plate System – K100614 - Orthofix |
| Additional Predicates: | Reliant Anterior Cervical Plate System - K030595 - Orthofix
SLIM*LOC Anterior Cervical Plate System - K013877 - Depuy
Codman & Shurtleff, Inc.
MaxAn Anterior Cervical Plate System - K133518 - Biomet |
Reason for 510(k) Submission: Orthofix is submitting this Traditional 510(k) premarket notification for the introduction of a new Anterior Cervical Plate System called CETRA Anterior Cervical Plate System.
Device Description
The CETRA Anterior Cervical Plate System consists of an assortment of non- sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) plates and screws that allow a surgeon to build a temporary anterior cervical implant construct. The plate is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine.
Intended Use / Indications for Use
The CETRA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
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Image /page/4/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. The "®" symbol is present to the right of the word "ORTHOFIX".
K162638 CETRA Anterior Cervical Plate System
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- b) Spondylolisthesis;
- c) Fracture:
- d) Spinal Stenosis:
- e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- f) Tumor:
- q) Pseudoarthrosis:
- h) Revision of previous surgery
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the CETRA Anterior Cervical Plate System are similar to the predicate device and reference device in terms of design, dimensions, intended use, materials, and performance characteristics. There are no significant differences between the CETRA Anterior Cervical Plate System and the predicate Hallmark Anterior Cervical Plate System (K100614) and the additional predicate devices Reliant Anterior Cervical System (K030595), SLIM*LOC Anterior Cervical Plate System (K013877) and MaxAn Anterior Cervical Plate System (K133518), which would adversely affect the use of the product.
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
Mechanical testing consisting of Static Axial Compression Test, Dynamic Axial Compression Test and Static Torsion Test were conducted in accordance to ASTM F1717. Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
Additional mechanical testing included a screw push-out test, which served to mechanically evaluate the CETRA Anterior Cervical Plate System locking mechanism's ability to retain screws after being implanted.
Conclusion
The new CETRA Anterior Cervical Plate System has the same intended use, the same indications for use, the same technological characteristics and design, same materials and the same principles of operation as the predicate Hallmark Anterior Cervical Plate System (K100614) and the additional predicate devices Reliant Anterior Cervical System (K030595), SLIM*LOC Anterior Cervical Plate System (K013877) and MaxAn Anterior Cervical Plate System (K133518).