(280 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
This device is intended for alignment correction, stabilization, and augmentation of spinal fusion, addressing conditions like fractures, tumors, degenerative disk disease, and spondylolisthesis, which are therapeutic functions.
No
Explanation: The K-Centrum Anterior Spinal Fixation System is described as a "multi-component system" and "implantable components" intended for "alignment correction and stabilization" and "spinal fusion." It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "multi-component system" utilizing "implantable components" such as "Vertebral Body Anchors", "Linkage rod", "Set screws", and "Locking caps", which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to correct and stabilize the spine. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device components are described as implantable hardware (anchors, rod, screws, caps).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (in glass, or outside the body) to analyze biological samples. This device is used in vivo (in the living body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
The K-Centrum Anterior Spinal Fixation System is intended for alignment correction and stabilization of the thoracolumbar spine. The K-Centrum is also intended to provide stabilization to augment the development of a solid spinal fusion. The K-Centrum is intended for threaded anchor/ fixation attachment to the anterolateral intervertebral bodies from T10 to L2 only and not more than 2 motion segments. The K-Centrum is indicated for vertebral body fractures and tumors.
The K-Centrum Anterior Fixator is intended for correction and stabilization of the spine. The K-Centrum is also intended to provide temporary stabilization and augment the development of a solid spinal fusion. The K-Centrum is intended for screw/bolt/fixation attachment to the anterolateral intervertebral bodies from T10 to L5 only and less than 4 motion segments.
The K-Centrum is indicated for degenerative disk disease, disk herniation, spondylosis, spondylolisthesis, burst fracture, failed surgery, corpectomy or vertebrectomy for tumor resection.
Product codes
KWQ
Device Description
The K-Centrum Anterior Spinal Fixation System is a multi-component system. The construct utilizes all of the following implantable components: Vertebral Body Anchors (Two); Linkage rod (One); Set screws (Two); Locking caps (Two). The K-Centrum System includes unique instrumentation to assist the surgeon in placing the anchors parallel to each other.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine, anterolateral intervertebral bodies from T10 to L2, spine, anterolateral intervertebral bodies from T10 to L5
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)
Results from comparative mechanical testing results shows that the K-Centrum performs comparably to the Z-Plate, and both devices exceed the minimum performance requirements outlined in the FDA guidance document, "Device Considerations for Spinal Fixation Device Systems", FDA, 1993. The testing included: Static Testing per ASTM 1717-96; Fatigue Testing per ASTM F 1717-96; Interconnection Testing: Set screw to linkage rod; Simulated Use Testing of Anchor Guidance System; and Comparative Anchor Pullout Testing. No new types of safety or effectiveness questions were raised as a result of the testing or risk analysis performed for the K-Centrum Anterior Spinal Fixation System.
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
§ 888.3060 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
SPINEOLOGY, INC
11:25 DEC-22-1999 Spineology Group Premarket Notification K-Centrum Anterior Spinal Fixation System
DEC 27 1995
510(k) Summary [As required by 21 CFR 807.92(c)] 4
4.1 Submitter Information
Manufacturer's Name & Address Manufacturer's Contact Person Pamela Snyder Spineology Group, LLC Director of Clinical & Regulatory Affairs 1815 Northwestern Avenue Phone: 651-351-1011 Fax: 651-351-0712 Stillwater, MN 55082
4.2 Device Names
| Proprietary Name: | K-Centrum Anterior Spinal Fixation System |
|---|---|
| Common/Usual Name: | anterior spinal fixation device |
| FDA Classification Name: | 21 CFR 888.3060, Spinal Intervertebral Body Fixation Orthosis |
| FDA Classification: | Class II, product code KWQ |
Predicate device 4.3
| Manufacturer | Device | 510(k) | Approved |
|---|---|---|---|
| Sofamor Danek | Z-Plate Anterior Fixation System | K922543 | 5/19/93 |
Device Description ব
The K-Centrum Anterior Spinal Fixation System is a multi-component system. The construct utilizes all of the following implantable components: Vertebral Body Anchors (Two); Linkage rod (One); Set screws (Two); Locking caps (Two). The K-Centrum System includes unique instrumentation to assist the surgeon in placing the anchors parallel to each other.
4.5 Intended Use
The K-Centrum Anterior Spinal Fixation System is intended for alignment correction and stabilization of the thoracolumbar spine. The K-Centrum is also intended to provide stabilization to augment the development of a solid spinal fusion. The K-Centrum is intended for threaded anchor/ fixation attachment to the anterolateral intervertebral bodies from T10 to L2 only and not more than 2 motion segments. The K-Centrum is indicated for vertebral body fractures and tumors.
Technological Characteristic Comparisons 4.6
In addition to having comparable intended use and indications for use, the K-Centrum Anterior Spinal Fixation System and the Sofamor Danek Z-Plate ATL Anterior Fixation System are substantially similar in design features. Both devices are manufactured from the same titanium alloy (Ti-6A1-4V, ELI), in accordance with the same standard material specification (ASTM F 136 - 96). Both system configurations include anchors, longitudinal elements for linkage, and
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March 18, 1999
1
Spineology Group Premarket Notification K-Centrum Anterior Spinal Fixation System
locking mechanisms. For safety reasons, the K-Centrum has been designed to be a low-profile implant, to minimize the opportunity for device impingement on soft tissues and vascular structures. Anchors for both systems are secured to the vertebral body by threaded attachment. The details of anchor geometry differ, in part because the Z-Plate utilizes two small diameter anchors in each vertebral body, while the K-Centrum employs a single larger diameter anchor. Both anchor systems provide comparable surface area for direct bone contact. The longitudinal linkage elements are of different configurations. The K-Centrum utilizes a round-cornered rectangular rod, nearly symmetrical in the transverse plane, for linkage; the Z-Plate has a contoured, relatively wide plate, asymmetrical in the transverse plane. Both linkage elements are designed to resist tension, compression, bending, and torsion. In both the K-Centrum and Z-Plate systems, the linkage component is secured to the anchors via a threaded clamping locking component: a locking nut for the Z-Plate, a set screw and locking cap for the K-Centrum.
Summarv of Testing 4.7
Results from comparative mechanical testing results shows that the K-Centrum performs comparably to the Z-Plate, and both devices exceed the minimum performance requirements outlined in the FDA guidance document, "Device Considerations for Spinal Fixation Device Systems", FDA, 1993. The testing included: Static Testing per ASTM 1717-96; Fatigue Testing per ASTM F 1717-96; Interconnection Testing: Set screw to linkage rod; Simulated Use Testing of Anchor Guidance System; and Comparative Anchor Pullout Testing. No new types of safety or effectiveness questions were raised as a result of the testing or risk analysis performed for the K-Centrum Anterior Spinal Fixation System.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized bird in flight, with three curved lines representing the wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 27 1999
Ms. Pamela Snyder Director of Clinical and Regulatory Affairs The Spineology Group, LLC 1815 Northwestern Avenue Stillwater, Minnesota 55082
Re: K990959
Trade Name: K-Centrum Anterior Spinal Fixation System Regulatory Class: II Product Code: KWQ Dated: September 28, 1999 Received: September 30, 1999
Dear Ms. Snyder:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 device, 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 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 Regulations, 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 regulation (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 regulations.
This letter will allow you to begin marketing your device as described in your 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.
3
Page 2 - Ms. Pamela Snyder
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil R.P. Ogden
James E. Dillard III
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INTENDED USE STATEMENT
Kgquggyyy
510(k) Number (if known):
Device Name: K-Centrum Anterior Spinal Fixation System
Indications for Use:
DLU CLE LE - LE
The K-Centrum Anterior Fixator is intended for correction and stabilization of the spine. The K-Centrum is also intended to provide temporary stabilization and augment the development of a solid spinal fusion. The K-Centrum is intended for screw/bolt/fixation attachment to the anterolateral intervertebral bodies from T10 to L5 only and less than 4 motion segments.
The K-Centrum is indicated for degenerative disk disease, disk herniation, spondylosis, spondylolisthesis, burst fracture, failed surgery, corpectomy or vertebrectomy for tumor resection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ARE for JZD | |
| Division of General Restorative Devices | ||
| 510(k) Number | K990959 | |
Prescription Use YES
(Per 21 CFR 801.109)
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