(82 days)
Not Found
No
The device description and intended use are purely mechanical in nature, describing a system of rods, screws, hooks, and connectors for spinal fixation. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes.
The device is indicated for conditions such as degenerative disc disease, fractures, spinal stenosis, deformities, and tumors, suggesting it is used to treat or alleviate these medical conditions.
No.
The device is a Titanium Spinal Rod System used for spinal fixation, which is a treatment or implantation device, not a diagnostic one.
No
The device description clearly 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 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 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: The text clearly describes the Titanium Spinal Rod System as a system of components (rods, screws, hooks, crosslinks, etc.) intended for spinal fixation. This is a surgical implant used to stabilize the spine.
- Intended Use: The intended use is for treating various spinal conditions by providing structural support and fixation. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The description focuses on the physical components, their materials, and how they are used to mechanically stabilize the spine during surgery. There is no mention of analyzing biological samples or providing diagnostic information.
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(T6-L5) and the anterior vertebral bodies of 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), tumors, 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 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-S1.
Product codes (comma separated list FDA assigned to the subject device)
MNH, KWP, and KWQ
Device Description
The components of the Titanium Spinal Rod System are not designed to be used with any other system except the bolts of the UlTium Spinal Plating System.
The material used is implant grade material that conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (TI-6Al-4V).
These device components are for single use. Cementless or cement fixation is not applicable to these components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, lumbar, thoracic, cervical, sacrum, 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)
Not Found
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.
K970635, Rogozinski Spinal Rod System, Richard's Universal Connector, Paragon Bolt Connector, Isola System, Richard's UlTium Plating System
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
MAR 1 0 1998 _
Aurora Titanium Spinal Rod System
FAX NO. 203 845 4503
| IX. | Summary of Safety and Effectiveness | |
|---|---|---|
| SUBMITTER: | United States Surgical Corporation | |
| 150 Glover Avenue | ||
| Norwalk, CT 06856 | ||
| CONTACT PERSON: | Sharon L. Murphy | |
| DATE PREPARED: | December 17, 1997 | |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis | |
| Spinal Interlaminal Fixation Orthosis | ||
| Spondylolisthesis Spinal Fixation Device System | ||
| COMMON NAME: | Titanium Spinal Rod System | |
| PROPRIETARY NAME: | Aurora Titanium Spinal Rod System | |
| PREDICATE DEVICES: | ||
| ♦ USSC's (formerly Smith & Nephew's) Aurora Titanium | ||
| Spinal Rod System (K970635) | ||
| ♦ USSC's (formerly Smith & Nephew's) Rogozinski Spinal | ||
| Rod System | ||
| ♦ Smith & Nephew's Richard's Universal Connector | ||
| ♦ Danek's Paragon Bolt Connector | ||
| ♦ AcroMed® Isola System | ||
| ♦ Smith and Nephew's Richard's UlTium Plating System | ||
| INTENDED 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(T6-L5) and the anterior vertebral | ||
| bodies of 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 illium. 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
1
Page 2012
Aurora Titanium Spinal Rod System
discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scollosis, kyphosis, lordosis), tumors, pseudoarthrosis, multi-operated back or revision of previous surgery.
When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/illac screws, pedicle screws and connectors the levels of attachment are lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is (a) having severe spondylolisthesis intended for patients: (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-S1.
These device components are for single use. Cementless or cement fixation is not applicable to these components.
The components of the Titanium Spinal Rod System are not designed to be used with any other system except the bolts of the UlTium Spinal Plating System.
The material used is implant grade material that conforms to MATERIALS: ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (TI-6Al-4V).
K974734/S1 United States Surgical Corporation
firmed by
cture, spina
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 1998
Ms. Sharon L. Murphy Requlatory Affairs Program Manager United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
Re : K974734 Aurora Titanium Spinal Rod System ------Regulatory Class: II Product Codes: MNH, KWP, and KWQ Dated: December 17, 1997 Received: December 18, 1997
Dear Ms. Murphy:
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 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.
3
Page 2 - Ms. Sharon L. Murphy
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, 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 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) vertebral 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.
- ◆ 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.
4
Page 3 - Ms. Sharon L. Murphy
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 4 . previous 510(k) clearances or required by OC/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 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 General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.
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
5
Page 4 - Ms. Sharon L. Murphy
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 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 (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
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Aurora Titanium Spinal Rod System
IV. Indications for Use
510(k) Number (if known):
Aurora Titanium Spinal Rod System Components Device Name:
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(T6-L5) and the anterior vertebral bodies of 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), tumors, pseudoarthrosis, multi-operated back or revision of previous surgery.
When used as a posterior pedicle system consisting of hooks, crosslinks, sacralifiliac screws, pedicle screws and connectors the levels of attachment are 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-S1.
(Please do not write below this line - continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation (QDE) |
|---|
| -------------------------------------------------------- |
| Prescription Use: | X |
|---|---|
| Use: |
OR Over-The-Counter
| (Per 21 CFR 801.109) | |
|---|---|
| -- | ---------------------- |
| Division Sign-Off | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K974734 |