(49 days)
Not Found
Not Found
No
The device description focuses on mechanical components and their function in spinal stabilization, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction for various medical conditions, which aligns with the definition of a therapeutic device.
No
The CerviFix System is an implantable device designed to provide stabilization and promote fusion of the cervical spine, indicated for various spinal conditions. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists and describes physical components such as rods, plates, hooks, and screws, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the CerviFix System is for providing stabilization to promote fusion of the cervical spine and occipital-cervical junction. This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as consisting of rods, plates, hooks, and screws made of titanium alloys. These are physical components designed for surgical implantation.
- Function: The description of how the device functions involves surgical procedures like inserting rods into hooks, positioning constructs under laminae, and fixing plates to the occiput with screws.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. The CerviFix System is an in vivo (inside the body) surgical implant.
N/A
Intended Use / Indications for Use
The CerviFix System is intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction (occiput – T3) for the following indications:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by . patient history and radiographic studies)
- spondylolisthesis ●
- spinal stenosis .
- fracture/dislocation .
- atlanto-axial fracture with instability .
- occipital-cervical dislocation .
- revision of previous cervical spine surgery .
- . tumors
The screws are limited to occipital fixation only.
The CerviFix System can also be linked to the Synthes Posterior Universal Spine System using the 3.5/6.0mm parallel connectors from that system.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
SYNTHES Spine CerviFix System consisting of rods, plate/rods, hooks, bone screws, parallel connectors and set screws. These components are manufactured from the titanium alloy TiAlNb (ASTM F1295). The bone screws are composed of commercially pure grade 4 Titanium (ASTM F67).
The rods are 3.5mm in diameter and are offered in four lengths, 80, 120, 240 and 300mm. The plate/rod is a 3.5 mm or 6.0 mm diameter rod that transitions into a 3.5mm reconstruction plate at the opposite end. Hooks are available in both a left and right configuration to allow bilateral placement of the hook/rod or plate/rod/hook construct. The occipital bone screws are provided in the following configurations: a 3.2mm cortex screw, a 3.5mm cancellous screw, or a 4.0mm cancellous screw.
The device functions as follows: For non occipitocervical fusion, the end of the rod, cut to an appropriate length, is inserted into the rod opening of the hooks and loosely tightened into position with the set screws included in the hooks. The construct is then positioned under the laminae of the spinal seaments to be instrumented. Once the construct is compressed together, the set screws are locked down to the rod. For occipitocervical fusion, the plate/rod is bent and cut to an appropriate length. The plate portion of the implant is fixed to the occiput with screws and the rod portion is attached to the cervical spine with hooks. Hooks are available in both right and left opening configurations to allow bilateral placement of the hook/rod construct.
The construct can also be linked to the 6.0mm diameter rods of the Universal Spine System (USS) using 3.5mm/6.0mm parallel connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and occipital-cervical junction (occiput – T3)
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)
Mechanical testing was previously performed in accordance with ASTM standard F1717. This testing documented both static and fatigue performance characteristics and demonstrated that the performance characteristics satisfy the requirements of posterior occipitocervical and upper thoracic (Occiput-T3) fixation.
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.
Not Found
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
510(k) Premarket Notification K984377 - Synthes CerviFix System - Additional Information
Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (U.S.A.) 1690 Russell Road Paoli. PA 19301
(610) 647-9700 Contact: Jonathan Gilbert 01/08/99
Device: SYNTHES Spine CerviFix System consisting of rods, plate/rods, hooks, bone screws, parallel connectors and set screws. These components are manufactured from the titanium alloy TiAlNb (ASTM F1295). The bone screws are composed of commercially pure grade 4 Titanium (ASTM F67).
The CerviFix System is intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction (occiput - T3) for the following indications:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by . patient history and radiographic studies)
- spondvlolisthesis .
- spinal stenosis ●
- fracture/dislocation .
- . atlanto-axial fracture with instability
- . occipital-cervical dislocation
- revision of previous cervical spine surgery .
- . tumors
The screws are limited to occipital fixation only.
The CerviFix System can also be linked to the Synthes Posterior Universal Spine System using the 3.5/6.0mm parallel connectors from that system.
The rods are 3.5mm in diameter and are offered in four lengths, 80, 120, 240 and 300mm. The plate/rod is a 3.5 mm or 6.0 mm diameter rod that transitions into a 3.5mm reconstruction plate at the opposite end. Hooks are available in both a left and right configuration to allow bilateral placement of the hook/rod or plate/rod/hook construct. The occipital bone screws are provided in the following configurations: a 3.2mm cortex screw, a 3.5mm cancellous screw, or a 4.0mm cancellous screw.
The device functions as follows: For non occipitocervical fusion, the end of the rod, cut to an appropriate length, is inserted into the rod opening of the hooks and loosely tightened into position with the set screws included in the hooks. The construct is then positioned under the laminae of the spinal seaments to be instrumented. Once the construct is compressed together, the set screws are locked down to the rod. For occipitocervical fusion, the plate/rod is bent and cut to an appropriate length. The plate portion of the implant is fixed to the occiput with screws and the rod portion is attached to the cervical spine with hooks. Hooks are available in both right and left opening configurations to allow bilateral placement of the hook/rod construct.
The construct can also be linked to the 6.0mm diameter rods of the Universal Spine System (USS) using 3.5mm/6.0mm parallel connectors.
Mechanical testing was previously performed in accordance with ASTM standard F1717. This testing documented both static and fatigue performance characteristics and demonstrated that the performance characteristics satisfy the requirements of posterior occipitocervical and upper thoracic (Occiput-T3) fixation.
1
Material composition is identical to numerous other Synthes Spinal products that have been meand via the 510(k) process. The methods for use and instrumentation to implant this system is similar to that of the Synthes CerviFix and the Occipital-Cervical Plate/Rod and Hook systems.
Based on the above, the Synthes Spine CerviFix System is substantially equivalent to components cleared in previously cleared Synthes premarket submissions.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with its head tilted back, and its arms outstretched. The figure is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 1999
Mr. Jonathan M. Gilbert Senior Regulatory Affairs Associate Synthes Spine Post Office Box 0548 1690 Russell Road Paoli, Pennsylvania 19301
Re: K984377
Synthes CerviFix System - additional components Regulatory Class: II Product Code: KWP Dated: December 2, 1998 Received: December 3, 1998
Dear Mr. Gilbert:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Jonathan M. Gilbert
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification K984377 - Synthes CerviFix System - Additional Information
Page 1 of 1
510(k) Number (if known): NA K984377
Device Name: Synthes CerviFix System
Indications for Use:
The CerviFix System is intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction (occiput – T3) for the following indications:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by . patient history and radiographic studies)
- spondylolisthesis ●
- spinal stenosis .
- fracture/dislocation .
- atlanto-axial fracture with instability .
- occipital-cervical dislocation .
- revision of previous cervical spine surgery .
- . tumors
The screws are limited to occipital fixation only.
The CerviFix System can also be linked to the Synthes Posterior Universal Spine System using the 3.5/6.0mm parallel connectors from that system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-the-Counter Use ____________(Per 21 CFR 801.109) OR Prescription Use
Piccolo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. 198437