(146 days)
No
The device description and performance studies focus on the mechanical properties and surgical instruments of a spinal fixation system, with no mention of AI or ML technology.
Yes
The device is described as "intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction" for treating various medical conditions, indicating a therapeutic purpose.
No
The device is described as a system for providing stabilization to promote fusion of the cervical spine, which indicates it is a therapeutic or surgical implant, not a diagnostic tool.
No
The device description explicitly details physical components made of titanium alloy and commercially pure titanium, including plates, rods, hooks, set screws, and bone screws, along with manual surgical instruments. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Synthes Spine Occipital-Cervical Plate/Rod and Hook System is a system of implants (plate/rods, hooks, set screws, and bone screws) made of titanium alloy. These are physical devices intended to be surgically implanted to provide stabilization.
- Intended Use: The intended use is to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction. This is a structural and mechanical function within the body, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant used for treatment, not for diagnosing a condition using a biological sample.
N/A
Intended Use / Indications for Use
The Synthes Spine Occipital-Cervical Plate/Rod and Hook System is intended to provide stabilization to promote fusion of the occipital-cervical junction (occiput-T3) for the following indications:
- Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with ● degeneration of the disc as confirmed by patient history and radiographic studies)
- . Spondvlolisthesis of the cervical vertebrae
- Spinal stenosis of the cervical vertebrae ●
- Atlanto-axial fracture with instability ●
- Occipital-cervical dislocation .
- Revision of cervical spine fusion surgeries .
- Tumors ●
The Synthes Spine Occipital-Cervical Plate/Rod and Hook System is indicated for the same clinical indications as that of the Ransford Cervical Fixation System (K965227).
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The Synthes Spine Occipital-Cervical Plate/Rod and Hook System consists of plate/rod. hooks, set screws The plate/rods, hooks, and set screws are and bone screws for the occipital region of the skull. manufactured from the titanium alloy TiAlNb (ASTM F1295). The bone screws are manufactured from commercially pure titanium Grade 4 (ASTM F67). 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. 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.
Manual surgical instruments that will be marketed with this system include Bending Pliers for 3.5 rods, a 2.5mm Hex screwdriver and holding forceps.
This system is provided non-sterile; moist heat sterilization is recommended.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Occipital-cervical junction (occiput-T3), cervical vertebrae
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 performed in accordance with ASTM standard F1717. This testing documented both static and fatigue performance characteristics. This testing and previous evaluation clearly demonstrated that the performance characteristics satisfy the requirements of posterior cervical and upper thoracic (TI-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
Additional Information C. Safety and Effectiveness Information NOV 25 1998
[510(k) Summary]
SYNTHES (U.S.A.) 1690 Russell Road Paoli. PA 19301
(610) 647-9700 Contact: Jonathan M. Gilbert 9/4/98
Device: Synthes Spine Occipital-Cervical Plate/Rod and Hook System compared to the Ransford Cervical Fixation System (K965221).
The Synthes Spine Occipital-Cervical Plate/Rod and Hook System consists of plate/rod. hooks, set screws The plate/rods, hooks, and set screws are and bone screws for the occipital region of the skull. manufactured from the titanium alloy TiAlNb (ASTM F1295). The bone screws are manufactured from commercially pure titanium Grade 4 (ASTM F67). The Occipital-Cervical Plate/Rod and Hook System is intended to provide stabilization to promote fusion of the occipital-cervical junction (occiput-T3) for the following indications:
- Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with ● degeneration of the disc as confirmed by patient history and radiographic studies)
- . Spondvlolisthesis of the cervical vertebrae
- Spinal stenosis of the cervical vertebrae ●
- Atlanto-axial fracture with instability ●
- Occipital-cervical dislocation .
- Revision of cervical spine fusion surgeries .
- Tumors ●
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. 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.
Manual surgical instruments that will be marketed with this system include Bending Pliers for 3.5 rods, a 2.5mm Hex screwdriver and holding forceps.
Mechanical testing was performed in accordance with ASTM standard F1717. This testing documented both static and fatigue performance characteristics. This testing and previous evaluation clearly demonstrated that the performance characteristics satisfy the requirements of posterior cervical and upper thoracic (TI-T3) fixation.
The Synthes Spine Occipital-Cervical Plate/Rod and Hook System is indicated for the same clinical indications as that of the Ransford Cervical Fixation System (K965227).
Material composition is identical to numerous other Synthes Spinal products that have been cleared via the 510(k) process. The surgical technique and instrumentation to implant this system is the same as that of the Synthes USS Hook/Rod systems.
This system is provided non-sterile; moist heat sterilization is recommended.
Based on the above, the Synthes Spine Occipital-Cervical Plate/Rod and Hook System is substantially equivalent to the Ransford Cervical Fixation System (K965221).
1
Image /page/1/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized image of an eagle with three heads. The eagle's heads are in profile, facing right, and are connected by a single body.
NOV 2 5 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jonathan M. Gilbert Senior Regulatory Affairs Associate Synthes Spine 1690 Russell Road Paoli. Pennsylvania 19301
Re: K982322
Trade Name: Occipital-Cervical Plate/Rod and Hook System Regulatory Class: II Product Code: KWP Dated: September 4, 1998 Received: September 8, 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 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 (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.
2
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 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,
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Intended Use Form
Page 1 of I
510(k) Number (if known): K982322
Device Name: Synthes Spine Occipital-Ccrvical Platc/Rod and Hook System
Indications for Use:
The Synthes Spine Occipital-Cervical Plate/Rod and Hook System is intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction (occiput - T3) for the following indications:
- Degenerative disease of the cervical vertebrae (neck pain of discogenic origin with . degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis of the cervical vertebrac ●
- Spinal stenosis of the cervical vertebrae .
- Atlanto-axial fracture with instability ●
- Occipital-cervical dislocation D
- Revision of cervical spine fusion surgeries .
- Tumors .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K982322
A.