(261 days)
Not Found
No
The summary describes a mechanical fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is described as a "Spine Anterior Fixation System" intended for "temporary stabilization of the anterior spine during the development of cervical spinal fusions." This describes a device used directly in the treatment of medical conditions, which aligns with the definition of a therapeutic device.
No
The device is a spine anterior fixation system, which is used for temporary stabilization and fixation of the cervical spine during fusions, not for diagnosing conditions.
No
The device description explicitly states that the system consists of bone plates, screws, and instruments, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes a surgical implant system (bone plates and screws) used for the anterior fixation of the cervical spine during fusion surgery. This is a device that is surgically implanted into the body to provide structural support.
- Lack of Specimen Handling: There is no mention of collecting, preparing, or examining any specimens from the human body.
- Focus on Mechanical Support: The performance studies described are mechanical tests (compression, fatigue, torsional) which are relevant to the structural integrity of an implant, not the diagnostic capabilities of an IVD.
Therefore, based on the provided information, the NeoOrtho NEOPLATE Spine Anterior Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NeoOrtho NEOPLATE Spine Anterior Fixation System is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma, (including fractures), 3) tumors, 4) deformity (defined by kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Note: this device system is intended for anterior cervical intervertebral body fusions only.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The NeoOrtho NEOPLATE Spine Anterior Fixation System consists of a variety of shapes and sizes of bone plates, screws and instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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 was performed according to ASTM F1717. The specific tests performed were:
- Compression Testing .
- Fatique Testing .
- Static Torsional Testing .
The mechanical testing results demonstrate substantial equivalence to other legally marketed devices.
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.
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 logo for "NEOORTHO". The logo consists of a black square with a white curved shape inside, followed by the word "NEOORTHO" in black, bold, sans-serif font. The letters are slightly rounded, giving the logo a modern and professional appearance.
| 510(k) Summary | MAY 1 4 2014 |
|---|---|
| Proprietary Name | NEOPLATE Spine Anterior Fixation System |
| 510(K) Number | K132653 |
| Date Prepared | May 12, 2014 |
| Submitter | NEOORTHO Produtos Ortopedicos S/A |
| Rua Angelo Domingos Durigan 607, | |
| Cascatinha | |
| Curitiba-PR, Brazil 82020-340 | |
| Telephone: +55 41 3535-1033 | |
| Fax: +55 41 3535-1018 | |
| Official Contact | Tara Conrad |
| TechLink International Consulting | |
| 18851 NE 29th Avenue Suite 720 | |
| Aventura, FL 33180 | |
| TEL- (305) 377-0077 | |
| Common Name | |
| Trade Name | |
| Regulatory Class | |
| Product Code | |
| Classification Panel | |
| Regulation Numbers | |
| Predicate Device | Appliance, fixation, spinal Intervertebral body |
| NEOPLATE Spine Anterior Fixation System | |
| Class II | |
| KWQ | |
| Orthopedic | |
| 21 CFR § 888.3060 | |
| K030327 Zephir Anterior Cervical System by | |
| Medtronic Sofamor Danek |
Device Description
The NeoOrtho NEOPLATE Spine Anterior Fixation System consists of a variety of shapes and sizes of bone plates, screws and instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
Indications for Use Statement
The NeoOrtho NEOPLATE Spine Anterior Fixation System is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma, (including fractures), 3) tumors, 4) deformity (defined by kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Note: this device system is intended for anterior cervical intervertebral body fusions only.
1
Image /page/1/Picture/0 description: The image shows the logo for "NEOORTHO". The logo consists of a stylized, abstract symbol on the left, resembling a curved shape within a square. To the right of the symbol is the word "NEOORTHO" in bold, sans-serif font. The overall design is simple and modern.
Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Material
The NEOPLATE is manufactured from titanium alloy as described in ASTM F136.
Performance Data
Mechanical testing was performed according to ASTM F1717. The specific tests performed were:
- Compression Testing .
- Fatique Testing .
- Static Torsional Testing .
The mechanical testing results demonstrate substantial equivalence to other legally marketed devices.
Technological Characteristics
The NEOPLATE System possesses the same technological characteristics as the predicate device. These include:
- Performance (described above) .
- . Basic design (plate and screw system)
- Material (titanium alloy) .
- . Size (dimensions are within the ranges of the predicate)
Therefore the fundamental scientific technology of the NEOPLATE System is the same as the previously cleared device.
Conclusion
The subject device and predicate device share the same indications for use, primary implant design and equivalent material of manufacture. In conclusion, the information provided and performance testing conducted demonstrate that the subject device is substantially equivalent to other legally marketed devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, with three curved lines representing the body and a base that suggests movement or support.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 14, 2014
NEOORTHO Produtos Orthopedicos S/A % TechLink International Consulting Ms. Tara Conrad Regulatory Affairs Manager 18851 Northeast 29th Avenue, Suite 720 Aventura, Florida 33180
Re: K132653
Trade/Device Name: NEOPLATE Spine Anterior Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 4, 2014 Received: April 11, 2014
Dear Ms. Conrad:
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.
1f 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Tara Conrad
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/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 yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132653
Device Name
NEOPLATE Spine Anterior Fixation System
Indications for Use (Describe)
The NeoOrtho NEOPLATE Spine Anterior Fixation System is interior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is incdicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma, (including fractures), 3) tumors, 4)deformity (defined by kyphosis, or scoliosis), 5) nseudarthrosis, and/or 6) failed previous fusions. Note: this device system is intended for anterior cervical intervertebral body fusions only.
Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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