(8 days)
Not Found
KWP, MNI
No
The device description and intended use clearly define the device as a system of mechanical components (rods, plates, screws, etc.) for spinal fixation. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as promoting fusion of the cervical spine and occipitocervical junction, treating conditions such as DDD, spondylolisthesis, spinal stenosis, and fractures/dislocations, which are therapeutic medical interventions.
No
Explanation: The device description clearly states that the Synthes CerviFix System consists of "rods, plate/rods, clamps, screws and nuts" which are used to "promote fusion of the cervical spine and occipitocervical junction" or "provide stabilization to promote fusion following reduction of fracture/dislocation or trauma." These are physical implants used for treatment and stabilization, not for diagnosing medical conditions.
No
The device description explicitly lists physical components made of titanium alloy and commercially pure titanium, indicating it is a hardware device, not software-only.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Synthes CerviFix™ System consists of implants (rods, plates, screws, hooks, clamps, nuts) made of titanium alloys. Its intended use is to provide stabilization and promote fusion in the cervical and upper thoracic spine for various conditions like DDD, spondylolisthesis, fractures, etc.
- No Mention of Samples or Testing: There is no mention of the device being used to analyze samples from the body or perform any kind of diagnostic test.
This device is a surgical implant used to treat structural issues in the spine, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Hooks, Plate/Rods, Rods and Screws
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex, 3.5 mm and 4.0 mm cancellous) components of the Synthes CerviFix™ System are indicating 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
When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods, Clamps, Screws and Nuts
The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).
The use of these screws (3.5 mm and 4.0 mm cancellous, 3.5 mm cortex, 4.0mm and 4.35 expansionhead) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system.
Product codes
KWP, MNI
Device Description
Synthes CerviFix System consists of rods, plate/rods, clamps, screws and nuts. The hooks, clamps, rods and plate/rods are composed of the titanium alloy Ti6Al7Nb (ASTM F1295). The screws are composed of commercially pure grade 4 Titanium (ASTM F67).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and occipitocervical junction (occiput-T3), cervical/upper thoracic (C1-T3) spine, upper thoracic spine (T1-T3)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 12/10/99
Device: Synthes CerviFix System consists of rods, plate/rods, clamps, screws and nuts. The hooks, clamps, rods and plate/rods are composed of the titanium alloy Ti6Al7Nb (ASTM F1295). The screws are composed of commercially pure grade 4 Titanium (ASTM F67).
Hooks, Plate/Rods, Rods and Screws
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex, 3.5 mm and 4.0 mm cancellous) components of the Synthes CerviFix™ System are indicating 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 .
When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods, Clamps, Screws and Nuts
The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).
The use of these screws (3.5 mm and 4.0 mm cancellous, 3.5 mm cortex, 4.0mm and 4.35 expansionhead) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 | 1999
Mr. Jonathan Gilbert Senior Regulatory Affairs Associate SYNTHES SPINE P.O. Box 0548 1690 Russell Road Paoli, Pennsylvania 19301
Re: K994187
Trade Name: Synthes CerviFix System Regulatory Class: II Product Code: KWP and MNI Dated: December 10, 1999 Received: December 13, 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.
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.
2
Page 2 -- Mr. Jonathan Gilbert
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 vours.
Neil R.P. Ogden
James E. Dillard III
for
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): NA K994187
Device Name: Synthes CerviFix System
Indications for Use:
Hooks, Plate/Rods, Rods and Screws
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex, 3.5 mm and 4.0 mm cancellous) components of the Synthes CerviFix™ System are indicating 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
When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods, Clamps, Screws and Nuts
The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).
The use of these screws (3.5 mm and 4.0 mm cancellous, 3.5 mm cortex, 4.0mm and 4.35 expansionhead) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm 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 | X | OR Over-the-Counter Use | (Per 21 CFR 801.109) |
|---|---|---|---|
| RA-01 | |||
| (Division Sign-Off) | NRO for | ||
| Division of General Restorative Devices | |||
| 510(k) Number | K994187 |
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