(147 days)
No
The device description focuses solely on the mechanical components and materials of a cervical plate system. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes.
The device is indicated for conditions such as degenerative disc disease, spondylolisthesis, trauma, and spinal stenosis, which signifies its role in treating medical conditions.
No
This device is an anterior cervical plate system, an implantable medical device used for spinal fusion, not for diagnosing medical conditions.
No
The device description clearly states it is a system made of medical grade titanium alloy consisting of plates and screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for stabilizing the cervical spine in patients with various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (plate and screws) made of titanium alloy, designed for surgical implantation. This is consistent with a medical device used in surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status based on in vitro analysis.
- Performance Studies: The performance studies described are mechanical tests (static and dynamic) of the implant's strength and durability, which are relevant for a surgical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Sintea Plustek Anterior Cervical Plate systems in indicated for use in the cervical spine (C3-C7) for the following conditions:
- Degenerative Disc Disease (defined as neck pain of discogenic origin with . Degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- Trauma (fracture or dislocation) .
- Spinal stenosis t
- Deformities or curvatures (scoliosis, kyphosis, lordosis) .
- Tumor .
- Pseudarthrosis
- Failed previous fusion
Product codes
KWQ
Device Description
The Sintea Plustek Anterior Cervical Plate system is made of medical grade titanium alloy Ti-6Al-4V according to ASTM-F136 and consists of plate and screws of various lengths to accommodate single or multilevel fusion and various patients' anatomy. All of the plates have 2.5mm thickness. One level plates are available from 18-38mm, two level plates from 34-56mm, three level plates from 68-112mm and 4 level plates from 103-128mm. The screws are available in three configurations: 4mm diameter self tapping screws in lengths of 10, 12, 14, 16 and 18mm. 4.5 diameter self tapping screws in lengths of 10, 12, 14, 16, and 18mm, 4mm diameter self drilling screws in lengths of 10, 12, 14, 16 and 18mm. The plates have an anti-backout feature based on an elastic ring (made titanium alloy Ti-6AI-4V as well). The elastic ring is inserted into a circumferential slot in the holes present on the plates. The ring can be deformed by the screw during the insertion in order to allow the screw to fit the hole of the plate. Once the screw it is completely inserted the ring return elastically to its original shape in order to prevent screw backout.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C3-C7)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The testing completed for the device under review was performed according to ASTM F1717-09 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." (Orthopaedics) including static compression bend, static tension, static tension, and dynamic compression bend. The test results were compared to the predicate device Sintea Biotech's Anterior Cervical Plate System (K041989) and showed equal or better performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Sintea Plustek, LLC, 407 Lincoln Rd. Suite 10L Miami Beach, FL 33139 P. 305-673-6226 F. 305-673-3312
I.
FEB 2 4 2012
Image /page/0/Picture/3 description: The image contains the text "sinteaPLUSTEK" in a simple, sans-serif font. The text is slightly curved, following the shape of a partial oval that surrounds it. The oval is thicker on the left side and thins out as it curves around the text.
Anterior Cervical Plate System 510(k) Summary November 2011
Sintea Plustek, LLC. Company: 407 Lincoln Rd. Suite 10L Miami Beach, FL 33139 (305) 673-6226
| II. | Proprietary Trade Name: | Anterior Cervical Plate System |
|---|---|---|
| Regulation Number: | 888.3060 | |
| Regulation Name: | Spinal Intervertebral Body Fixation Orthosis | |
| Product Code: | KWQ |
III. Product Description
The Sintea Plustek Anterior Cervical Plate system is made of medical grade titanium alloy Ti-6Al-4V according to ASTM-F136 and consists of plate and screws of various lengths to accommodate single or multilevel fusion and various patients' anatomy. All of the plates have 2.5mm thickness. One level plates are available from 18-38mm, two level plates from 34-56mm, three level plates from 68-112mm and 4 level plates from The screws are available in three configurations: 4mm diameter self 103-128mm. tapping screws in lengths of 10, 12, 14, 16 and 18mm. 4.5 diameter self tapping screws in lengths of 10, 12, 14, 16, and 18mm, 4mm diameter self drilling screws in lengths of 10, 12, 14, 16 and 18mm. The plates have an anti-backout feature based on an elastic ring The elastic ring is inserted into a (made titanium alloy Ti-6AI-4V as well). circumferential slot in the holes present on the plates. The ring can be deformed by the screw during the insertion in order to allow the screw to fit the hole of the plate. Once the screw it is completely inserted the ring return elastically to its original shape in order to prevent screw backout.
IV. Indications for Use
The Sintea Plustek Anterior Cervical Plate systems in indicated for use in the cervical spine (C3-C7) for the following conditions:
- Degenerative Disc Disease (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
- . Spondylolisthesis
- . Trauma (fracture or dislocation)
- . Spinal stenosis
- Deformities or curvatures (scoliosis, kyphosis, lordosis) ●
- . Tumor
- . Pseudarthrosis
- . Failed previous fusion
,
.
1
Sintea Plustek, LLC. 407 Lincoln Rd, Suite 10L Miami Beach, FL 33139 P. 305-673-6226 F. 305-673-3312
Image /page/1/Picture/1 description: The image shows the logo for "sinteaplustek". The logo is in a simple, sans-serif font, with the two words joined together. The logo is enclosed in a thin, oval border. The text is in black and the background is white.
V. Predicate Devices
The Sintea Plustek Atnerior Cervical Plate is substantially equivalent to the Sintea Biotech Anterior Cervical Plate (K041989), the Synthes CSLP Variable Angle Plate (K000536) and the DePuy Skyline ACP (K103491).
Performance Data - Overview VI.
The testing completed for the device under review was performed according to ASTM F1717-09 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." (Orthopaedics) including static compression bend, static tension, static tension, and dynamic compression bend. The test results were compared to the predicate device Sintea Biotech's Anterior Cervical Plate System (K041989) and showed equal or better performance.
VII. Substantial Equivalence Conclusion
Sintea Plustek, LLC believes that the additions to the Anterior Cervical Plate System are substantially equivalent to the Sintea Biotech's Anterior Cervical Plate Spinal System (K041989) with respect to functional design, indications for use, principles of operation, performance, and materials.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS). The seal features the HHS logo, which is a stylized caduceus, a symbol of medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the logo.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 2 4 2012
Sintea Plustek, LLC % Ms. Danielle Wernikowski 407 Lincoln Road, Suite 10L Miami Beach, Florida 33139
Re: K112861
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: KWO Dated: January 23, 2012 Received: January 27, 2012
Dear Ms. Wernikowski:
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
3
Page 2 - Ms. Danielle Wernikowski
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A Milheim
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Sintea Plustek, LLC. 407 Lincoln Rd, Suite 10L Miami Beach, FL 33139 P. 305-673-6226 F. 305-673-3312
Image /page/4/Picture/2 description: The image shows the logo for Sintea Plustek. The logo is in black and white and features the company name in a stylized font. The text is surrounded by a partial oval shape on the left side of the text.
Indications for Use
510(k) Number (if known): ___K112861
Device Name: Anterior Cervical Plate System
Indications for Use:
The Sintea Plustek Anterior Cervical Plate systems in indicated for use in the cervical spine (C3-C7) for the following conditions:
- Degenerative Disc Disease (defined as neck pain of discogenic origin with . Degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- Trauma (fracture or dislocation) .
- Spinal stenosis t
- Deformities or curvatures (scoliosis, kyphosis, lordosis) .
- Tumor .
- Pseudarthrosis
- Failed previous fusion
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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) |
|---|
| -------------------------------------------------------- |
Signature
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
K112861 510(k) Number