(49 days)
No
The device description and intended use focus on the mechanical components and surgical application of a spinal rod system, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as the "Rogozinski Spinal Rod System," intended for the treatment of various spinal conditions such as DDD, pseudoarthrosis, stenosis, deformities, fractures, and tumors, indicating its purpose is to provide therapy for these medical conditions.
No
The device is a Rogozinski Spinal Rod System, which is an implantable medical device used for spinal fixation and stabilization as an adjunct to fusion. Its intended use is for treatment of various spinal conditions, not for diagnosing them.
No
The device description explicitly states that the system consists of "stainless steel rods attached to the spinal column through the use of interlaminal hooks and/or screws," which are physical hardware components.
Based on the provided information, 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 Rogozinski Spinal Rod System is described as a system of stainless steel rods, hooks, and screws that are surgically implanted into the spinal column.
- Intended Use: The intended use is for the surgical treatment of various spinal conditions by providing stabilization and immobilization.
- No mention of testing biological samples: The document does not describe any process of analyzing biological samples from the patient. The mention of "radiographic studies" refers to imaging techniques used for diagnosis and planning, not in vitro testing.
Therefore, the Rogozinski Spinal Rod System is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Non-Pedicle Screw Fixation
When used as an anterior spinal system the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use.
When used as a posterior, non-pedicle spinal system (consisting of hooks and sacral/iliac screws), the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use.
Pedicle Screw Fixation
When used as a pedicle screw system, in the spine of skeletally mature patients, the Rogozinski Spinal Rod System is indicated 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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Rogozinski Spinal Rod System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Product codes
MNI, MNH, KWQ, KWP
Device Description
The Rogozinski Spinal Rod System consists of stainless steel rods attached to the spinal column through the use of interlaminal hooks and/or screws. Crossbars may be used to connect rods to rods to provide a more rigid construct, as well as screws to rods and hooks to rods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal column, non-cervical spine, anterior spinal system, posterior spinal system, lumbar and sacral spine (L3 and below), L5-S1 joint, thoracic, lumbar, and sacral spine.
Indicated Patient Age Range
skeletally mature patients
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)
K884263, K896106, K930298, K950865, K954696, K965224
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.
0
| DEC 22 1998 | Rogozinski Spinal System
Summary of Safety and Effectiveness | | K983904
page 1 of 2 |
|-------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | SUBMITTER: | United States Surgical Corporation
150 Glover Avenue
Norwalk, CT 06856 | |
| | CONTACT PERSON: | Sharon L. Murphy | |
| | DATE PREPARED: | September 29, 1998 | |
| | CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis
Spinal Interlaminal Fixation Orthosis
Spondylolisthesis Spinal Fixation Device System | |
| | COMMON NAME: | Spinal Rod System | |
| | PROPRIETARY NAME: | Rogozinski Spinal Rod System | |
| | PREDICATE DEVICES: | USSC's Surgical Dynamics™ Rogozinski Spinal Rod
System - K884263, K896106, K930298, K950865,
K954696, K965224 | |
| | DEVICE DESCRIPTION: | The Rogozinski Spinal Rod System consists of stainless
steel rods attached to the spinal column through the use of
interlaminal hooks and/or screws. Crossbars may be used
to connect rods to rods to provide a more rigid construct,
as well as screws to rods and hooks to rods. | |
| | INTENDED USE: | Non-Pedicle Screw Fixation | |
| | | When used as an anterior spinal system the Rogozinski
Spinal Rod System is intended for the treatement of DDD
(degenerative disc disease defined as back pain of
discogenic origin with degeneration of the disc confirmed
by history or radiographic studies), pseudoarthrosis,
stenosis, deformities (scoliosis, kyphosis, lordosis),
spondylolisthesis, fracture, previous failed fusion, or tumor
resection. The Rogozinski Spinal Rod System is limited to
non-cervical use. | |
| | | When used as a posterior, non-pedicle spinal system
(consisting of hooks and sacral/iliac screws), the
Rogozinski Spinal Rod System is intended for the
treatement of DDD (degenerative disc disease defined as
back pain of discogenic origin with degeneration of the
disc confirmed by history or radiographic studies),
pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis,
lordosis), spondylolisthesis, fracture, previous failed fusion,
or tumor resection. The Rogozinski Spinal Rod System is
limited to non-cervical use. | |
10/11/2
1
Surnmary of Safety and Effectiveness
K983906 Page 2 of 2
Pedicle Screw Fixation INTENDED USE :
When used as a pedicle screw system, in the spine of (continued) skeletally mature patients, the Rogozinski Spinal Rod System is indicated 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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Rogozinski Spinal Rod System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral degenerative spondylolisthesis with objective spine: evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
MATERIALS: The material used is implant grade material that conforms to ASTM F138 standards for stainless steel.
ു.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them, resembling a bird or a symbol of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 1998
Ms. Sharon L. Murphy Regulatory Affairs Program Manager United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
K983899 Re : Thoracolumbar Spinal Rod System (Empower) Trade Name: K983904 Roqozinski Spinal Rod System Trade Name: Requlatory Class: II Product Codes: MNI, MNH, KWQ, and KWP October 30, 1998 Dated: November 3, 1998 Received:
Dear Ms. Murphy:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (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 action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does
3
Page 2 - Ms. Sharon L. Murphy
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.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, 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
Enclosures
4
Rogozinski Spinal System
Indications for Use
510(k) Number (if known): K983904
Rogozinski Spinal Rod System Device Name:
Indications For Use:
Non-Pedicle Screw Fixation
When used as an anterior spinal system the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scollosis, kyphosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use.
When used as a posterior, non-pedicle spinal system (consisting of hooks and sacral/iliac screws), the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use.
Pedicle Screw Fixation
When used as a pedicle screw system, in the spine of skeletally mature patients, the Rogozinski Spinal Rod System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the LS-S1 igint: (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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Rogozinski Spinal Rod System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine. degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
(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) |
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983904
A1