(42 days)
Not Found
No
The device description and intended use are purely mechanical in nature, describing titanium plates and screws for spinal stabilization. There is no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes
The device is a cervical plate system indicated for stabilization and fixation of the cervical spine, addressing conditions like instability, trauma, and degenerative disc disease, which are therapeutic interventions.
No
The device is an anterior cervical plate system designed for stabilization and fixation of the cervical spine, which are therapeutic functions, not diagnostic.
No
The device description explicitly states that the systems consist of titanium alloy plates and screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the SKYLINE, UNIPLATE, and UNIPLATE 2 Anterior Cervical Plate Systems are implants made of titanium alloy plates and screws. Their intended use is for the stabilization and fixation of the cervical spine during surgical procedures.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. It is a physical implant used directly on the patient's anatomy.
Therefore, this device falls under the category of a surgical implant or medical device used for structural support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SKYLINE Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
The UNIPLATE Anterior Cervical Plate System and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
The UNIPLATE and UNIPLATE 2 Anterior Cervical Plate Systems are also indicated for treatment of spinal stenosis.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The UNIPLATE® and UNIPLATE® 2 Anterior Cervical Plate Systems consist of an assortment of titanium alloy plates and screws. The anterior cervical plates are available in various lengths to accommodate one to three segments of fixation. The screws are available in various sizes and tip geometries.
The SKYLINE® Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to six screw hole pairs in various lengths: The screws are available in various sizes and screw-tip geometries. Both constrained and variable screws are available to create a constrained, variable or hybrid configuration.
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, anterior cervical, 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)
Performance data is not provided in this submission.
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.
K052552, 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.
0
510(K) SUMMARY
- A. Submitter Information Manufacturer:
. Submitter:
Medos International Sárl Chemin-Blanc 38 2400 Le Locle, Switzerland
DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767
Contact Person:
Telephone number: Fax number: Email:
Kirsten Lehmuller 325 Paramount Drive Raynham, MA 02767 508-828-3291 508-828-3797 klehmull@its.jnj.com
B. Date Prepared July 25, 2013
C. Device Name
Trade/Proprietary Name:
SKYLINE® Anterior Cervical Plate System, UNIPLATE® Anterior Cervical Plate System, and UNIPLATE®2 Anterior Cervical Plate System
Common/Usual Name:
Spinal System
Classification Name:
Spinal intervertebral body fixation orthosis per 21 CFR §888.3060
D. Predicate Device Name
Trade name: SKYLINE® Anterior Cervical Plate System (K052552) UNIPLATE® Anterior Cervical Plate System (K042544) UNIPLATE®2 Anterior Cervical Plate System (K082273, K100070)
SEP 06 2013
1
E. Device Description
The UNIPLATE® and UNIPLATE® 2 Anterior Cervical Plate Systems consist of an assortment of titanium alloy plates and screws. The anterior cervical plates are available in various lengths to accommodate one to three segments of fixation. The screws are available in various sizes and tip geometries.
The SKYLINE® Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to six screw hole pairs in various lengths: The screws are available in various sizes and screw-tip geometries. Both constrained and variable screws are available to create a constrained, variable or hybrid configuration.
F. Intended Use
The SKYLINE Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
The UNIPLATE Anterior Cervical Plate System and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
The UNIPLATE and UNIPLATE2 Anterior Cervical Plate Systems are also indicated for treatment of spinal stenosis.
2
F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The proposed modifications to the SKYLINE®, UNIPLATE®, and UNIPLATE® 2 Anterior Cervical Plate Systems are identical to the predicate devices (K042544, K052552, K082273, and K100070) except for the proposed devices will be terminally sterilized via gamma radiation. The design, materials, indications, and technology remain identical to the predicate systems.
G. Materials
Manufactured from ASTM F-136 implant grade titanium alloy.
H. Performance Data
Performance data is not provided in this submission.
l. Conclusion
The Substantial Equivalence Justification demonstrates that the devices are as safe, as effective, and perform as well as the predicate devices.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.
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
September 6, 2013
DePuy Spine, Incorporated % Ms. Kirsten Lehmuller Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K132324
Trade/Device Name: SKYLINE® Anterior Cervical Plate System, UNIPLATE® Anterior Cervical Plate System, and UNIPLATE®2 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: August 6, 2013 Received: August 7, 2013
Dear Ms. Lehmuller:
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
4
Page 2 - Ms. Kirsten Lehmuller
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Ni 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 STATEMENT
510(k) Number (if known): K132324
Device Name: SKYLINE® Anterior Cervical Plate System, UNIPLATE® Anterior Cervical Plate System, and UNIPLATE®2 Anterior Cervical Plate System
Indications For Use:
The SKYLINE Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instabliity caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
The UNIPLATE Anterior Cervical Plate System and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kvphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
The UNIPLATE and UNIPLATE 2 Anterior Cervical Plate Systems are also indicated for treatment of spinal stenosis.
AND/OR
Prescription Use X _
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Caroline & Im - S
(Division Sign-Off) Division of Orthopedic Devices 510{k} Number: K132324