(80 days)
Not Found
No
The summary describes a mechanical implant (cervical plate and screws) and its intended use for spinal stabilization. There is no mention of software, algorithms, image processing, AI, ML, or performance studies related to such technologies. The change described is related to sterilization.
Yes.
The device is used for stabilization of the cervical spine, which is a therapeutic intervention for various medical conditions listed under "Indications for Use."
No
The device is a surgical implant designed for stabilization of the cervical spine, not for identifying the presence or absence of a disease or condition.
No
The device description explicitly states it consists of cervical plates and screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The SKYLINE® Anterior Cervical Plate System is a surgical implant used to stabilize the cervical spine. It is physically implanted into the body and does not analyze biological specimens.
The information provided clearly describes a surgical implant, not a device used for in vitro testing.
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 pseudoarthorosis 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 myleopathy.
Product codes
KWQ
Device Description
The SKYLINE® System consists of cervical plates and screws which are terminally sterilized via gamma radiation. Previously, these devices were commercialized as clean, but non-sterile, and the end-user would need to sterilize the units prior to use via steam sterilization. Certain screws will be packaged in sterile multi-packs for customer convenience.
Manufactured from ASTM F-136 implant grade titanium alloy.
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
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
Not Found
Key Metrics
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
510(K) SUMMARY
K103491
FEB 14 2011
A. Submitter Information
DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767
| Contact Person: | Frank S. Jurczak
Sr. Regulatory Affairs Associate |
|-----------------|------------------------------------------------------|
| Voice: | (508) 828-3288 |
| Fax: | (508) 828-3797 |
| E-Mail: | FJurczak@its.jnj.com |
- B. Date Prepared 24 November 2010
- C. Device Name
| Trade/Proprietary Name: | SKYLINE® Anterior Cervical Plate System |
|---|---|
| Common/Usual Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| per 21 CFR §888.3060 |
D. Predicate Device Name
Trade name: SKYLINE® Anterior Cervical Plate System, cleared as the Hybrid Anterior Cervical Plate System (K052552)
E. Device Description
The SKYLINE® System consists of cervical plates and screws which are terminally sterilized via gamma radiation. Previously, these devices were commercialized as clean, but non-sterile, and the end-user would need to sterilize the units prior to use via steam sterilization. Certain screws will be packaged in sterile multi-packs for customer convenience.
1
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 pseudoarthorosis 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 myleopathy.
F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The proposed devices are identical to the predicate devices except that the proposed devices will be terminally sterilized by DePuy Spine via gamma radiation. The design, materials, and technology remain identical to the predicate systems.
Materials G.
Manufactured from ASTM F-136 implant grade titanium alloy.
H. Biocompatibility
The sterile SKYLINE® devices do not require biocompatibility testing.
Conclusion l.
The Substantial Equivalence Justification demonstrates that the device is as safe, as effective, and performs as well as the predicate device
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes extending upwards. The bird is positioned above a wavy line, possibly representing water or a horizon. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration i 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Spine, Inc. % Mr. Frank S. Jurczak Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
FEB 14 2011
Re: K103491
Trade/Device Name: SKYLINE® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: K WQ Dated: January 14, 2011 Received: January 18, 2011
Dear Mr. Jurczak:
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 indictions 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 In Included in Intelsidio 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, ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbrandinionny 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 micheding.
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
:
States of the country
:
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Page 2 – Mr. Frank S. Jurczak
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 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/CDRHQffices/ucm11.5809.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.
AK B. R
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: SKYLINE® 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: Instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthorosis 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 myleopathy.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIO3491 510(k) Number_