(175 days)
There are no K/DEN numbers listed in the provided text for Predicate Devices.
Not Found
No
The summary describes a mechanical spinal fixation system made of titanium components, with no mention of software, algorithms, or any features related to AI or ML.
Yes
The device is described as a "Titanium Spinal Rod System" used for "spinal fixation" with indications for various spinal conditions like degenerative disc disease, spondylolisthesis, fracture, and deformities, which clearly points to its therapeutic purpose.
No
This device is a Titanium Spinal Rod System indicated for spinal fixation, used in surgeries to stabilize the spine. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of physical components like rods, screws, hooks, crosslinks, and connectors made of titanium alloy, which are implanted for spinal fixation. This is a hardware medical device, not software-only.
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 and Intended Use: The description clearly states that this is a "Titanium Spinal Rod System" used for "spinal fixation." It involves surgically implanting rods, screws, hooks, and connectors into the spine, sacrum, and ilium. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) test.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, laboratory testing, or diagnostic purposes related to analyzing bodily fluids or tissues.
Therefore, this device falls under the category of a surgical implant or medical device used for structural support and fixation within the body, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The components of the Titanium Spinal Rod System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine and the anterior vertebral bodies of the cervical spine. Intended uses for this device include anterolateral screw fixation to the noncervical spine, lumbar spine, T6-L5 spine and to the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scollosis, kyphosis, lordosis), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery.
When used as a nonpedicle posterior system consisting of hooks, crosslinks, and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery.
When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint, the levels of pedicle screw fixation may be L3-SI.
Product codes
MNH, KWP and KWQ
Device Description
The material used is implant grade material that conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (Ti-6Al-4V). The devices are for single use. Cement fixation is not applicable to this device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar, thoracic and cervical spine; sacrum and ilium
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)
The testing results were acceptable and the components should perform well in clinical usage.
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
§ 888.3060 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
KA7 0635
Exhibit 10
Summary of Safety and Effectiveness
Smith & Nephew Orthopaedics
AUG 1 4 1997
Titanium Spinal Rod System
The components of the Titanium Spinal Rod System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine and the anterior vertebral bodies of the cervical spine. Intended uses for this device include anterolateral screw fixation to the noncervical spine, lumbar spine, T6-L5 spine and to the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scollosis, kyphosis, lordosis), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery.
When used as a nonpedicle posterior system consisting of hooks, crosslinks, and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery.
When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint, the levels of pedicle screw fixation may be L3-SI.
The devices are for single use. Cement fixation is not applicable to this device. These devices have not been submitted to the FDA for different or similar intended uses.
The material used is implant grade material that conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (Ti-6Al-4V).
The testing results were acceptable and the components should perform well in clinical usage.
Image /page/0/Picture/13 description: The image displays the word "CONFIDENTIAL" in large, outlined, sans-serif font. The word is presented in all capital letters and spans the width of the image. The outline style gives the text a somewhat faded or stencil-like appearance, with the interior of each letter appearing white against a darker background.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 depiction of an eagle or bird-like figure, composed of three curved lines that suggest the head and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carole Coles Requlatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
AUG 1 4 1997
K970635 Re : Titanium Spinal Rod System Regulatory Class: II Product Codes: MNH, KWP and KWQ Dated: May 23, 1997 Received: May 27, 1997
Dear Ms. Coles:
We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act (Act). This decision is based on your device system being found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against
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misbranding and adulteration. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f)(1) of the Act. "
This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III device under Section 513(f.) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
- All labeling for this device, including the package label, 1. must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass .
- You may not label or in anyway promote this device system 2. for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:
WARNINGS :
- When used as a pedicle screw system, this device � system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebrai joint.
- The screws of this device system are not intended ● for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
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- Benefit of spinal fusions utilizing any pedicle ● screw fixation system has not been adequately established in patients with stable spines.
- Potential risks identified with the use of this ● device system, which may require additional surgery, include :
device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.
- Any pedicular screw fixation/attachment for intended uses 3 . other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investiqation.
- Any previous warning statements identified as part of !
マイ previous 510(k) clearances or required by 00/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.
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
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Page 4 - Ms. Carole Coles
Federal Requlations, 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 requlation (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 Requlations.
FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 requlation 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
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Page 5 - Ms. Carole Coles
at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/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
6
Exhibit 1
STATEMENT OF INDICATIONS
The components of the Titanium Spinal Rod System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine and the anterior vertebral bodies of the cervical spine. Intended uses for this device include anterolateral screw fixation to the noncervical spine, lumbar spine, T6-L5 spine and to the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery.
When used as a nonpedicle posterior system consisting of hooks, crosslinks, and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine, and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery.
When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint, the levels of pedicle screw fixation may be L3-SI.
The devices are for single use. Cementless or cement fixation is not applicable to this device. These devices have not been submitted to the FDA for different intended uses.
tocoella
(Division Sign-Off) Division of General Restorative Devices K970635 510(k) Number _
Prescription Use (Per 21 CFR 801.109)