(246 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the cervical plate system, with no mention of AI or ML capabilities.
Yes
Explanation: The device is intended for the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with various conditions such as degenerative disc disease, trauma, and tumors. This directly addresses medical conditions and aims to alleviate symptoms or restore function, fitting the definition of a therapeutic device.
No
This device is an Anterior Cervical Plate System, which is an implantable surgical device used for stabilization of the spine, not for diagnosing conditions.
No
The device description clearly states it is a "cervical plate" and "bone screws," which are physical hardware components 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.
- Device Description: The provided description clearly states that this is an Anterior Cervical Plate System, which is a surgical implant used for anterior screw fixation to the cervical spine. It is a physical device implanted into the body to provide structural support and aid in fusion.
- Intended Use: The intended use is for temporary stabilization of the anterior spine during the development of cervical spinal fusion. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The information provided describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
· degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
· spondylolisthesis,
- · trauma (i.e. fractures or dislocations),
- · tumors.
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudarthrosis.
- · failed previous fusion,
- · spinal stenosis
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Osteomed Implantes Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (22 mm - 110mm), addressing multiple levels of fixation (one to six). The Osteomed plate incorporates holes or vision ports on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Bone screws are available in two diameters (Ø3.85 mm and Ø4.25 mm) and a variety of lengths (8mm - 20mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2 to T1)
Indicated Patient Age Range
skeletally mature patients
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)
Non-clinical Test Summary: The following analyses were conducted: Static and dynamic compression per ASTM F1717 Static torsion per ASTM F1717 The results of these evaluations indicate that the Anterior Cervical Plate System is equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed
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.
K031276, K030866, K000742, K000536, K945700, K080646, K042544, K082273, K100070
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2016
Osteomed Implantes, LTDA % Mr. J.D. Webb The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K151553
Trade/Device Name: 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: January 5, 2016 Received: January 8, 2016
Dear Mr. Webb:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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/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/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 yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151553
Device Name Anterior Cervical Plate System
Indications for Use (Describe)
The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
· degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
· spondylolisthesis,
- · trauma (i.e. fractures or dislocations),
- · tumors.
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudarthrosis.
- · failed previous fusion,
- · spinal stenosis
| 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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| Date Prepared | June 5, 2015 |
|---|---|
| Submitted By | Osteomed Implantes, LTDA |
| Washington Luiz Road, km 172 | |
| Condomínio Conpark - Rua 6, S/N | |
| CEP 13501-600 | |
| Rio Claro - SP | |
| BRAZIL | |
| (19) 3532-3411 Tele | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| 512-692-3699 Fax | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | Anterior Cervical Plate System |
| Common Name | anterior cervical plate |
| Classification Name | Spinal intervertebral body fixation orthosis |
| Class | II |
| Product Code | KWQ |
| CFR Section | 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Cervical Spine Locking Plate (CSLP) - Synthes (K031276/K030866/K000742/ |
| K000536/K945700) | |
| Additional Predicate | |
| Devices | C-Tek MaxAn Anterior Cervical Plate System - Biomet Spine (K080646) |
| UNIPLATE ANTERIOR CERVICAL PLATE, - DePuy (K042544 / K082273 / | |
| K100070) | |
| Device Description | The Osteomed Implantes Anterior Cervical Plate System is intended for anterior |
| screw fixation of the plate to the cervical spine. The fixation construct consists of | |
| a cervical plate that is attached to the vertebral body of the cervical spine with | |
| self-tapping bone screws using an anterior approach. Plates are available in a | |
| variety of lengths (22 mm - 110mm), addressing multiple levels of fixation (one to | |
| six). The Osteomed plate incorporates holes or vision ports on the longitudinal | |
| center line for intraoperative visualization and for screw fixation of bone graft. | |
| Bone screws are available in two diameters (Ø3.85 mm and Ø4.25 mm) and a | |
| variety of lengths (8mm - 20mm). | |
| Materials | Commercially pure titanium conforming to ASTM F67 |
| Titanium alloy (Ti6Al4V) conforming to ASTM F136 | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The Anterior Cervical Plate System is substantially equivalent to the predicate |
| devices in terms of intended use, design, materials used, mechanical safety, and | |
| performances. | |
| Indications for Use | The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: |
| degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spinal stenosis | |
| Non-clinical Test Summary | The following analyses were conducted: Static and dynamic compression per ASTM F1717 Static torsion per ASTM F1717 The results of these evaluations indicate that the Anterior Cervical Plate System is equivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-clinical and Clinical | Osteomed Implantes considers the Anterior Cervical Plate System to be equivalent to the predicate device listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials, and indications for use |
510(k) Summary: Anterior Cervical Plate System
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