(90 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device, a spinal rodding system, is used to treat various medical conditions such as degenerative disc disease, spondylolisthesis, fracture, and deformities, by providing immobilization and stabilization to spinal segments, thus directly treating and alleviating symptoms of several diseases.
No
The provided text describes a "Rodding System" consisting of screws, hooks, and rods intended for spinal fusion. This device is an implantable surgical system used to treat various spinal conditions, not to diagnose them.
No
The device description explicitly states it consists of screws, hooks, rods, crossbars, offset screws, clips, and rod-to-rod connectors, all made of Ti-6Al-4V. These are physical hardware components, not software.
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 this device is a surgical implant system consisting of screws, hooks, rods, and other components designed to be implanted into the spine.
- Intended Use/Indications for Use: The intended use and indications describe the surgical application of the device for treating various spinal conditions like degenerative disc disease, fractures, deformities, etc. This involves direct intervention within the body, not testing samples outside the body.
Therefore, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When used as an anterolateral/anterior system, the levels of attachment are the lumbar, thoracic, and cervical spine. The points of attachment are screw fixation into the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5) and 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, or failed previous fusion.
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. 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, or failed previous fusion.
When used as a pedicle screw system in the non-cervical spine of skeletally mature patient, the system is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at 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 solid fusion mass.
In addition, when used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the system is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Surgical Dynamics Spiral Radius 90-D Rodding System is to be used in conjunction with the SDRS Spinal Rods, SDRS Spinal Rod with Sacral Eye and the SDRS Locking Screw.
Product codes (comma separated list FDA assigned to the subject device)
KWP, KWQ, MNI, MNH
Device Description
The Spiral Radius 90-D Rodding System consists mainly of 1) screws and hooks that are implanted in vertebral bodies and 2) rods that fit into and are locked upon the screw heads using a locking cap. The system also includes crossbars that connect 2 parallel-running rods, offset screws and clips that allow a rod to be placed in certain situations where a direct connection to the vertebrae would cause excessive bending of the rod, and rod-to-rod connectors that allow a construct to be extended. All components of the system are composed of Ti-6Al-4V which conforms to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar, thoracic, cervical spine, sacrum, ilium, vertebral bodies
Indicated Patient Age Range
Skeletally mature patient
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, including static and dynamic compression testing and static torsion testing.
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.
Surgical Dynamics Rodding 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.
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
510(k) SUMMARY
020134
Surgical Dynamics™, 150 Glover Avenue, Norwalk, CT 06856 USA
| CONTACT PERSON: | Jenny Schuck |
|---|---|
| PRODUCT NAME: | Spiral Radius 90-D Rodding System |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis |
| Spinal Interlaminal Fixation Orthosis | |
| Spondylolisthesis Spinal Fixation Device System | |
| PREDICATE DEVICE: | Surgical Dynamics Rodding System |
DEVICE DESCRIPTION
The Spiral Radius 90-D Rodding System consists mainly of 1) screws and hooks that are implanted in vertebral bodies and 2) rods that fit into and are locked upon the screw heads using a locking cap. The system also includes crossbars that connect 2 parallel-running rods, offset screws and clips that allow a rod to be placed in certain situations where a direct connection to the vertebrae would cause excessive bending of the rod, and rod-to-rod connectors that allow a construct to be extended. All components of the system are composed of Ti-6Al-4V which conforms to ASTM F136.
INDICATIONS FOR USE
When used as an anterolateral/anterior system, the levels of attachment are the lumbar, thoracic, and cervical spine. The points of attachment are screw fixation into the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5) and 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, or failed previous fusion.
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. 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, or failed previous fusion.
When used as a pedicle screw system in the non-cervical spine of skeletally mature patient, the system is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at 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 solid fusion mass.
In addition, when used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the system is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Surgical Dynamics Spiral Radius 90-D Rodding System is to be used in conjunction with the SDRS Spinal Rods, SDRS Spinal Rod with Sacral Eye and the SDRS Locking Screw.
1
TESTING
Mechanical testing was performed, including static and dynamic compression testing and static torsion testing.
SUBSTANTIAL EQUIVALENCE*
The components added to the Spiral Radius 90-D Rodding System were claimed to be substantially The components added to the Sphar Rashas 70 D iterstang System (K970635). The Spiral Radius 90equivalent " to components of the Bargeor was claimed to be substantially equivalent* to the Spinal D Koduling System Rod to Rod Connector and the Spiral Radius 90-D Rodding System Multi-Angle Concepts Daci is Life-to End Combeter ining to these devices was provided in the submission.
- Any claim of substantial equivalence is made exclusively in regard to the U.S. Food, Drug and Cosmetic Act and should not be viewed in any other light.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines, and the overall design is simple and modern. The logo is likely used to represent the department on official documents and communications.
APR 1 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jenny Schuck Regulatory Affairs Senior Associate United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856
K020134 Re: Spiral Radius 90-D Rodding System Regulation Numbers: 888.3050; 888.3060; and 888.3070 Regulation Names: Spinal Interlaminal Fixation Orthosis; Spinal Intervertebral Body Fixation Orthosis; Spondylolisthesis Spinal Fixation Device System; and Pedicle Screw Spinal System
Regulatory Class: II Product Codes: KWP, KWQ, MNI, MNH Dated: January 14, 2002 Received: January 15, 2002
Dear Ms. Schuck:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conimered prior to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, de necs that have been recuire approval of a premarket approval application (PMA). and Cosmotion Free (110) that the device, subject to the general controls provisions of the Act. I ou may, therefore, maner and to 150, at include requirements for annual registration, listing of The general controls provision, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is blusbined toor as cotrols. Existing major regulations affecting your device can may be subject to sublications, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i tease of acreation that i broundevice complies with other requirements of the Act that I Dr Hear Intactions and regulations administered by other Federal agencies. You must or unf 1 catal bather bequirements, including, but not limited to: registration and listing (21 compry with an all the 110 01 CFR Part 801); good manufacturing practice requirements as set OFF Part 8017; and ity systems (21 CFR Part 820); and if applicable, the electronic roluct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Jenny Schuck
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter with and your e FDA finding of substantial equivalence of your device to a legally premainer noninate 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 21 CFR Part 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 compliance at (301) 594-4639 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
Mark N. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS ENCLOSURE
510(k) Number (if known): K020134
Spiral Radius 90-D Rodding System Device Name:
Indications For Use:
March 28, 2002
When used as an anterolateral/anterior system, the levels of attachment are the lumbar, thoracic, and cervical spine. The points of attachment are screw fixation into the anterolateral vertebral bodies of the cervical spine. The points of the minent and on vertebral bodies of the cervical spine. The indications are lumbal and inoracie spine (11 L29) and all pain of discogenic origin with degeneration of the disc degenerative dise unsease (connect as bath pes), spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.
When used as a nonpedicle, posterior system consisting of hooks, crosslinks, and sacral/iliae screws, the When used as a nonpodiers, person thoracic, and cervical spine and the sacrum and ilium. The indications are degenerative disc disease (defined as back pain of discogenic origin with degeneration of Indications are degenciative and radiographic studies), spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, tordosis), tumor, pseudoarthrosis, or failed previous fusion.
When used as a pedicle screw system in the non-cervical spine of skeletally mature patient, the system is when used as a pentents: (a) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (b) who are indivated for patients. (a) having severe posit only, (c) who are having the device fixed or attached to the receiving rasions using adlegements occa: and (d) who are having the device removed after the development of solid fusion mass.
In addition, when used as a pedicle screw system in the non-cervical spine of skeletally mature patients, In adultion, when used as a pocure convilization and stabilization of spinal segments as an adjunct to the system is intended to provide anims acute and chronic instabilities or deformities of the thoracic, lusion in the treatinent of the long with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Surgical Dynamics Spiral Radius 90-D Rodding System is to be used in conjunction with the SDRS The Surglear Dymannonial Rod with Sacral Eye and the SDRS Locking Screw.
(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) |
for Mark N Mellesun
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K020134 |
|---|---|
| --------------- | --------- |
United States Surgical, Surgical Dynamics
510(k) K020134
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