(114 days)
Not Found
No
The description focuses on the mechanical and structural aspects of a spinal implant and does not mention any AI/ML components or functionalities.
Yes
The device is intended for anterior plate and screw fixation of the cervical spine to provide stabilization as an adjunct to cervical fusion, addressing conditions like degenerative disc disease, trauma, and spinal stenosis, which are typically treated to alleviate symptoms or restore function.
No
Explanation: This device is an implantable plate and screw system intended for stabilizing the cervical spine as an adjunct to fusion, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical plate and screw system intended for surgical implantation, not a software-only device.
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 Zero-P Natural Plate is a physical implant designed for surgical fixation of the cervical spine. It is a structural device used within the body, not for testing samples outside the body.
- Intended Use: The intended use clearly states it's for "anterior plate and screw fixation of the cervical spine" and "to provide stabilization as an adjunct to cervical fusion." This is a surgical intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic information.
Therefore, based on the provided information, the Zero-P Natural Plate is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The plate and four screw system has been designed for use with structural allograft to provide stabilization as an adjunct to cervical fusion. Indications for use of this plate system include degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis or scoliosis), tumor, pseudarthosis or failed previous fusion. The plate is intended for one level in the cervical spine, from C2 to T1.
Product codes
KWQ
Device Description
The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The Zero-P Natural Plate and four screw system has been designed to provide stabilization as an adjunct to cervical fusion. The Zero-P Natural Plate is secured to the spine through unicortical fixation with bone screws. The plate is positioned flush with the adjacent vertebral bodies. Four bone screws attach to the plate for fixation through the adjacent vertebral bodies; two screws are directed into the superior and inferior vertebrae through the endplates.
The Zero-P Natural Plate has been designed for use with a Musculoskeletal Transplant Foundation (MTF) allograft spacer. Size pairings of the Zero-P Natural Plate and the allograft spacer are identified in the labeling to ensure a proper fit and height relationship of the allograft spacer to the Zero-P Natural Plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, from C2 to T1
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)
In order to characterize the Zero-P Natural Plate and establish its substantial equivalence, mechanical, as well as biomechanical testing was conducted in a comparative manner. The mechanical properties of the Zero-P Natural Plate were evaluated through the following tests in accordance with ASTM F1717-14 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model:
- static compression bending,
- static torsion and .
- dynamic compression bending.
The biomechanical properties of the Zero-P Natural Plate were evaluated through a cyclic cadaveric range of motion study in which the Zero-P Natural Plate and predicate plate were tested.
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
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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 2, 2015
Synthes USA, LLC % Ms. Laura Bleyendaal Regulatory Affairs Associate DePuy Synthes 325 Paramount Drive Raynham, Massachusetts 02767
Re: K152239
Trade/Device Name: Zero-P Natural Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 6, 2015 Received: November 9, 2015
Dear Ms. Bleyendaal:
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
1
Page 2 - Ms. Laura Bleyendaal
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,
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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Indications for Use
510(k) Number (if known) к152239
Device Name Zero-P Natural Plate System
Indications for Use (Describe)
The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The plate and four screw system has been designed for use with structural allograft to provide stabilization as an adjunct to cervical fusion. Indications for use of this plate system include degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis or scoliosis), tumor, pseudarthosis or failed previous fusion. The plate is intended for one level in the cervical spine, from C2 to T1.
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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3
510(k) Summary
B.
C.
A. Submitter Information
| 510(k) Sponsor: | Synthes USA, LLC
1101 Synthes Avenue
Monument, CO 80132 |
|--------------------------------------------|-------------------------------------------------------------------------------|
| Contact Person: | Laura Bleyendaal
DePuy Synthes
325 Paramount Drive
Raynham, MA 02767 |
| Telephone number:
Fax number:
Email: | (508) 828-3267
(508) 828-3797
LBleyend@its.jnj.com |
| Date Prepared | November 6, 2015 |
| Device Name | |
| Trade/Proprietary Name: | Zero-P Natural Plate System |
| Common/Usual Name: | Spinal intervertebral body fixation orthosis |
| Device Classification
and Regulation: | Class II per 21 CFR § 888.3060 |
| Classification Product and Panel | |
D. Predicate Device Name
Code:
Primary Predicate Device: Optio-CTM Anterior Cervical Plate System (K141500) Additional Predicate Device: VECTRA-ONE™ Cervical Plate (K071667)
KWQ; Orthopedic
E. Device Description
The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The Zero-P Natural Plate and four screw system has been designed to provide stabilization as an adjunct to cervical fusion. The Zero-P Natural Plate is secured to the
4
spine through unicortical fixation with bone screws. The plate is positioned flush with the adjacent vertebral bodies. Four bone screws attach to the plate for fixation through the adjacent vertebral bodies; two screws are directed into the superior and inferior vertebrae through the endplates.
The Zero-P Natural Plate has been designed for use with a Musculoskeletal Transplant Foundation (MTF) allograft spacer. Size pairings of the Zero-P Natural Plate and the allograft spacer are identified in the labeling to ensure a proper fit and height relationship of the allograft spacer to the Zero-P Natural Plate.
F. Indications for Use
The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The plate and four screw system has been designed for use with structural allograft to provide stabilization as an adjunct to cervical fusion. Indications for use of this plate system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion. The plate is intended for one level in the cervical spine, from C2 to T1.
G. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The technological characteristics including material, design and performance of the Zero-P Natural Plate are consistent with those of the predicate devices.
H. Materials
The Zero-P Natural Plate and screws are manufactured from titanium alloy conforming to ASTM F1295 which is anodized.
I. Performance Data
In order to characterize the Zero-P Natural Plate and establish its substantial equivalence, mechanical, as well as biomechanical testing was conducted in a comparative manner. The mechanical properties of the Zero-P Natural Plate were evaluated through the following tests in accordance with ASTM F1717-14 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model:
- static compression bending,
- static torsion and .
- o dynamic compression bending.
The biomechanical properties of the Zero-P Natural Plate were evaluated through a cyclic cadaveric range of motion study in which the Zero-P Natural Plate and predicate plate were tested.
5
J. Conclusion
The indications for use and intended use of the Zero-P Natural Plate are consistent with that of the predicate devices. The technological characteristics of the Zero-P Natural Plate in terms of design, materials and performance are consistent with those of the predicate devices. The Zero-P Natural Plate is substantially equivalent to the aforementioned predicate devices.