(149 days)
Not Required
No
The device description focuses on mechanical components and their function for spinal stabilization. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
This device is designed to stabilize the cervical spine and occipitocervical junction to promote fusion, which directly addresses therapeutic outcomes for conditions like DDD, spondylolisthesis, spinal stenosis, and fractures.
No
The device description indicates that the CerviFix System is used for stabilization to promote fusion, rather than for diagnosing conditions. The indications for use mention that certain conditions like DDD are confirmed by patient history and radiographic studies, implying that diagnosis occurs prior to the use of this device.
No
The device description explicitly lists physical components such as rods, plates, hooks, and screws, and describes their material composition and function in providing mechanical stabilization. This indicates it is a hardware device, not software-only.
Based on the provided text, the CerviFix System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The CerviFix System is a surgical implant. Its intended use is to provide stabilization and promote fusion of the cervical spine and occipitocervical junction. It is a physical device implanted into the body, not a tool for analyzing biological samples.
The description clearly outlines the mechanical components of the system (rods, plates, screws, etc.) and how they are used surgically to stabilize the spine. This is consistent with a medical device intended for implantation, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The CerviFix System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient ● history and radiographic studies
- Spondylolisthesis ●
- Spinal stenosis .
- Fracture/dislocation .
- Atlantoaxial fracture with instability ●
- Occipitocervical dislocation ●
- Revision of previous cervical spine surgery .
- Tumors .
The CerviFix Plate/Rods are intended to provide stabilization to promote fusion of the cervical rnic oci in ix i later rous light - T3). The screws are limited to occipital fixation only. In addition, the CerviFix Rods are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The CerviFix System can also be linked to the Synthes 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 CerviFix System consists of rods, plate/rods, hooks, bone screws, parallel connectors, trans-connector clamps, parallel connectors and set screws. These components are manufactured from the titanium alloy TiAINb (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. In addition, trans-connector clamps are available in a left and right version. A 3.5mm/3.5mm parallel rod connector is offered with the system. 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 segments 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.
To add a trans-connector construct, a 3.5 mm rod is cut to fit across two longitudinallyplaced 3.5 mm rods. Once the trans-connector clamps are attached to the longitudinal rods and transverse rod, the set screws are locked down to the rods. To use the parallel rod connector, two rods are inserted into the rod openings of the connector and the set screws are locked down to the rods.
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, occipitocervical junction (occiput - T3), cervical/upper thoracic (C1-T3) spine
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.
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
13991089 Synthes CerviFix System Special 510(k) Premarket Notification - Device Line Extension
Summary of Safety and Effectiveness Information
[510(k) Summary]
AUG 27 1999
SYNTHES (U.S.A.) 1690 Russell Road
Paoli, PA 19301
(610) 647-9700 Contact: Jonathan Gilbert 03/30/99
Device: SYNTHES CerviFix System consists of rods, plate/rods, hooks, bone screws, parallel connectors, trans-connector clamps, parallel connectors and set screws. These components are manufactured from the titanium alloy TiAINb (ASTM F1295). The bone screws are composed of commercially pure grade 4 Titanium (ASTM F67).
The CerviFix System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed . by patient history and radiographic studies
- Spondylolisthesis .
- Spinal stenosis .
- . Fracture/dislocation
- Atlantoaxial fracture with instability .
- Occipitocervical dislocation ●
- Revision of previous cervical spine surgery .
- . Tumors
The CerviFix Plate/Rods are intended to provide stabilization to promote fusion of the cervical spine and occipitocervical junction (occiput - T3). The screws are limited to occipital fixation only. In addition, the CerviFix Rods are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The CerviFix System can also be linked to the Synthes 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. In addition, trans-connector clamps are available in a left and right version. A 3.5mm/3.5mm parallel rod connector is offered with the system. 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 segments 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.
1
To add a trans-connector construct, a 3.5 mm rod is cut to fit across two longitudinallyplaced 3.5 mm rods. Once the trans-connector clamps are attached to the longitudinal rods and transverse rod, the set screws are locked down to the rods. To use the parallel rod connector, two rods are inserted into the rod openings of the connector and the set screws are locked down to the rods.
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.
Material composition is identical to numerous other Synthes Spinal products that have been cleared via the 510(k) process. The methods for use and instrumentation to implant this system is similar to that of the Synthes CerviFix Systems, K984722.
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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three wavy lines above it, possibly representing support or care.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Mr. Jonathan Gilbert Senior Regulatory Affairs Associate Synthes Spine P.O. Box 0548 Paoli. Pennsylvania 19301
Re: K991089 Trade Name: CerviFix System Regulatory Class: II Product Code: KWP Dated: July 1, 1999 Received: July 2, 1999
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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 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 your 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" (21 CFR 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Num C. J. Rogers
ﺮﺓ - 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
Page 1 of 1
510(k) Number (if known): NA
Device Name: Synthes CerviFix System
Indications for Use:
The CerviFix System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient ● history and radiographic studies
- Spondylolisthesis ●
- Spinal stenosis .
- Fracture/dislocation .
- Atlantoaxial fracture with instability ●
- Occipitocervical dislocation ●
- Revision of previous cervical spine surgery .
- Tumors .
The CerviFix Plate/Rods are intended to provide stabilization to promote fusion of the cervical rnic oci in ix i later rous light - T3). The screws are limited to occipital fixation only. In addition, the CerviFix Rods are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The CerviFix System can also be linked to the Synthes 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)
Prescription Use _ OR Over-the-Counter Use _ (Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K991089
RA-01 Pre-market Notification CerviFix