(168 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
No.
The device is a pedicle screw system intended for immobilization and stabilization of spinal segments as an adjunct to fusion, which falls more under surgical/fixation devices rather than therapeutic ones.
No
The device is a pedicle screw system intended for immobilization and stabilization of spinal segments as an adjunct to fusion, which is a treatment modality, not a diagnostic one.
No
The device description explicitly states it consists of "a variety of hooks, screws, rods, connectors, and associated instruments," which are physical hardware components.
No, 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, such as blood, urine, or tissue, to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
- Device Description: The Conklusion Pedicle Screw System is described as a spinal system consisting of hooks, screws, rods, connectors, and instruments used for immobilization and stabilization of spinal segments. These are implantable medical devices used directly on the patient's anatomy.
- Intended Use: The intended use is to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly indicates this is a surgical implant system, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Conklusion Pedicle Screw System, including hook, is 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 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).
In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH
Device Description
The ConKlusion Pedicle Screw System is a spinal system that consists of a variety of hooks, screws, rods, connectors, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using posterior approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine, L5-S1 vertebra, L3 to S1
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)
Functional and Mechanical testing of the subject device consisted of three static mechanical tests and one dynamic test to evaluate the spinal implant assemblies. The three static mechanical tests are compression bending, tensile bending, and torsion. The dynamic test is compression bending fatigue. All testing was conducted in accordance with ASTM F1717. The result of the testing was successful. The device performed as designed and met, or exceeded, all product specifications.
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.
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
OCT 2 2 2003
SECTION 2. SUMMARY AND CERTIFICATION
510(k) Summary A.
| Submitter: | SIGNUS Medical, LLC. |
|---|---|
| Contact Person: | Mr. Thomas Hoghaug, Managing Director |
| SIGNUS Medical LLC | |
| 6713 Lakeway Drive | |
| Chanhassen, MN 55317 | |
| Telephone: (952) 974-9456 | |
| Fax: (952) 975-0465 | |
| Date Prepared: | May 5, 2003 |
| Trade Name: | The ConKlusion Pedicle Screw System |
| Classification, Name | |
| and Number: | Class II |
| Pedicle Screw System | |
| 21 CFR 888.3070 | |
| Product Code: | MNI and MNH |
| Predicate Device(s): | The subject device is substantially equivalent to the following |
| devices: | |
| ● Plus Pivot Link Universal System (K022271), manufactured by | |
| SpineVision, Inc. | |
| ● Global Spinal Fixation System (K001668), manufactured by | |
| D.K.M Co., LTD. | |
| ● Triple-Fix Spinal Fixation System (K992147), manufactured | |
| by Advanced Spine Technology, Inc. | |
| Device Description: | The ConKlusion Pedicle Screw System is a spinal system that |
| consists of a variety of hooks, screws, rods, connectors, and | |
| associated instruments. Fixation is provided by bone (pedicular) | |
| screws inserted into the vertebral body of the spine using posterior | |
| approach. | |
| Intended Use: | The Conklusion Pedicle Screw System, including hook, is 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 instabilities or deformities of the thoracic, | |
| lumbar, and sacral spine: degenerative spondylolisthesis with | |
| objective evidence of neurological | |
| impairment, fracture. |
1
dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.
Functional and Mechanical testing of the subject device consisted of three static Safety Testing: mechanical tests and one dynamic test to evaluate the spinal implant assemblies. The three static mechanical tests are compression bending, tensile bending, and torsion. The dynamic test is compression bending fatigue. All testing was conducted in accordance with ASTM F1717. The result of the testing was successful. The device performed as designed and met, or exceeded, all product specifications.
SIGNUS Medical LLC considers the ConKlusion Pedicle Screw Conclusion: System to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in functional design, materials、 and a indications for use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person's profile.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2003
SIGNUS Medical, LLC C/o Ms. Tracy L. Gray, R.N., B.S., RAC Senior Consultant Alquest, Inc. 4050 Olson Memorial Hwy., Suite 350 Minneapolis, Minnesota 55422
Re: K031455
Trade Name: Conklusion® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: September 8, 2003 Received: September 9, 2003
Dear Ms. Gray:
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, 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 (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.
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Page 2 - Ms. Tracy L. Gray, R.N., B.S., RAC
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Mark N. Millers
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
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Indications for Use Page .
Device Name: The Conklusion® Pedicle Screw System
The Conklusion Pedicle Screw System, including hooks, is 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 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).
In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1.3 to S l ) with removal of the implants after the attainment of a solid fusion.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A Wilkerson
vision Sion. ision of General, Restorative ad Neurologic
10(k) Number