(64 days)
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not related to AI/ML performance.
Yes
The device is intended to immobilize and stabilize spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities, which aligns with the definition of a therapeutic device.
No
Explanation: The Cadence™ Spinal Fixation System is described as a "temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion." It is a treatment device, not one used for diagnosis.
No
The device description explicitly states that the system consists of temporary implants made from titanium alloy, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to stabilize the spine and facilitate fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical implants (screws, rods, hooks) made of titanium alloy, which are surgically implanted into the body. This is consistent with a medical device used for treatment.
- No mention of in vitro testing: The text does not mention any testing of samples (blood, tissue, etc.) outside of the body, which is the hallmark of an in vitro diagnostic device.
- Mechanical Testing: The performance studies focus on mechanical testing of the implants, not on diagnostic accuracy or performance related to analyzing biological samples.
Therefore, the Cadence™ Spinal Fixation System is a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system in skeletally mature patients, the Cadence™ Spinal Fixation 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 or deformities 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).
In addition, when used as a pedicle screw fixation system, the Cadence Spinal Fixation System is indicated for use in patients:
- a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
- b) who are receiving fusions with autogenous graft only
- c) who are having the device fixed or attached to the lumbar or sacral spine; and
d) who are having the device removed after the development of a solid fusion mass When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.
When used as a hook and sacral screw system, the Cadence Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Cadence Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.
Product codes
MNI, MNH, KWP
Device Description
The Cadence™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varving diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. The implants in this system are manufactured from titanium allov (Ti-6Al-4V) that conforms to ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Mechanical testing was carried out according to ASTM F 1717-96 and ASTM F 1798-97 to validate the Cadence™ Spinal Fixation System. The testing demonstrated substantially equivalent mechanical properties to the previously cleared Silhouette™ Spinal Fixation System components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
SEP 2 4 2002
510(k) Summary
| Submitter: | Centerpulse Spine-Tech
7375 Bush Lake Road
Minneapolis, Minnesota 55439 |
|------------------------------------------|-------------------------------------------------------------------------------|
| Date Prepared: | August 19, 2002 |
| Contact: | Kristyn M. Benson
Regulatory Affairs Specialist |
| Proprietary Name: | Cadence™ Spinal Fixation System |
| Common Name: | Rod, hook, and screw spinal instrumentation |
| Device Product Code
& Classification: | Class II; MNI, MNH, and KWP |
| Predicate Device: | Silhouette™ Spinal Fixation System
(K980288 & K992276) |
Device Description:
The Cadence™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varving diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. The implants in this system are manufactured from titanium allov (Ti-6Al-4V) that conforms to ASTM F-136.
Intended Use:
When used as a pedicle screw fixation system in skeletally mature patients, the Cadence Spinal Fixation 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 or deformities 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).
In addition, when used as a pedicle screw fixation system, the Cadence Spinal Fixation System is indicated for use in patients:
- a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
- b) who are receiving fusions with autogenous graft only
Cadence™ Spinal Fixation System Special 510(k) Notification
1
- c) who are having the device fixed or attached to the lumbar or sacral spine; and
- d) who are having the device removed after the development of a solid fusion mass
When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.
When used as a hook and sacral screw system, the Cadence Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Cadence Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.
Statement of Technological Comparison:
Mechanical testing was carried out according to ASTM F 1717-96 and ASTM F 1798-97 to validate the Cadence™ Spinal Fixation System. The testing demonstrated substantially equivalent mechanical properties to the previously cleared Silhouette™ Spinal Fixation System components.
Cadence™ Spinal Fixation System Special 510(k) Notification
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2002
Ms. Kristyn M. Benson Regulatory Affairs Specialist Centerpulseº - Spine-Tech Division 7375 Bush Lake Road Minneapolis, Minnesota 55439-2027
K022374 Re:
| K022374 | |
|---|---|
| Trade Name: | Cadence™ Spinal Fixation System |
| Regulation Number: | 21 CFR 888.3070, 21 CFR 888.3050 |
| Regulation Name: | Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis |
| Regulatory Class: | Class II |
| Product Code: | MNI, MNH, KWP |
| Dated: | August 29, 2002 |
| Received: | August 30, 2002 |
Dear Ms. Benson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Ms. Kristyn M. Benson
This letter will allow you to begin marketing your device as described in your Section 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 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 your device, please contact the Office 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/dsmamain.html.
Sincerely yours.
Mach A. Melleman
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
4
INDICATIONS FOR USE STATEMENT
K022374 510(k) Number:
Cadence™ Spinal Fixation System Device Name:
Indications for Use:
When used as a pedicle screw fixation system in skeletally mature patients, the Cadence™ Spinal Fixation 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 or deformities 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).
In addition, when used as a pedicle screw fixation system, the Cadence Spinal Fixation System is indicated for use in patients:
- a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
- b) who are receiving fusions with autogenous graft only
- c) who are having the device fixed or attached to the lumbar or sacral spine; and
d) who are having the device removed after the development of a solid fusion mass When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.
When used as a hook and sacral screw system, the Cadence Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Cadence Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.
PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K022374
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter-Use_
Cadence™ Spinal Fixation System Special 510(k) Notification