(66 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.
No.
The device is a spinal fixation system designed to stabilize and promote spinal fusion, not to provide therapy or treatment itself. Its purpose is to support the spine while healing occurs, and the implants are removed after fusion.
No
Explanation: The device is a spinal fixation system, which is an implant used to stabilize the spine and promote fusion. Its purpose is therapeutic for severe spondylolisthesis and other spinal instabilities, not to diagnose medical conditions.
No
The device description explicitly states it consists of physical components like pedicle screws, rods, set screws, connectors, and a transverse linking mechanism, all fabricated from titanium alloy. This indicates it is a hardware-based medical device.
Based on the provided information, the Rexious Spinal Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Rexious Spinal Fixation System is a surgical implant used to stabilize the spine. It is a physical device implanted into the body, not a tool for analyzing biological samples.
The description clearly states its intended use is for spinal fixation and fusion, and the device description details its components as pedicle screws, rods, etc., which are all physical implants.
N/A
Intended Use / Indications for Use
The Rexious Spinal Fixation System is a posterior 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 sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Rexious Spinal Fixation System is intended to provide immobilization 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI, KWP
Device Description
The Rexious Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism.
The Rexious Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The DIO Spinal System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, L5-S1 vertebra, L3 to sacrum, thoracic lumbar and sacral spine
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Surgeons
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)
The addition of components to the system did not introduce a new worst case construct, and therefore no additional testing was performed.
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
JUL 2 1 2011
510(k) Summary
Submitter: DIO Medical Co., Ltd. Shin Chan Soo 103~105 Megacenter, SK Technopark 190-1 Sangdaewon-dong, Jungwon-gu Sungnam-si Kyunggi-do, South Korea Phone: 82-31-776-3690 Fax: 82-31-776-3691
Official Correspondent: Kodent Inc. April Lee 325 N. Puente St. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-0116
Device Information
| Trade Name: | Rexious Spinal Fixation System |
|---|---|
| Common Name: | Pedicle Screw Spinal Fixation System |
| Classification Name: | Pedicle Screw Spinal System |
| Product Code: | MNH, MNI, KWP |
| Regulation Number: | 21 CFR 888.3070 |
| The date of submission: | 5/12/2011* |
General Description
The Rexious Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism.
The Rexious Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The DIO Spinal System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available.
Device Modification & Technological Characteristics
The purpose of this 510(k) submission is to add lengths of rods (Type A and B), diameters of rod (Type C), and surgical instruments. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.
1
Indication for Use
The Rexious Spinal Fixation System is a posterior 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 sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Rexious Spinal Fixation System is intended to provide immobilization 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Materials:
All components are made of Ti6Al4V alloy, a titanium based alloy which complies with ASTM F136.
Performance Data
The addition of components to the system did not introduce a new worst case construct, and therefore no additional testing was performed.
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
- Fixpine II System (K100765)
Comparison to Predicate Devices:
The comparisons have established that the subject of Rexious Spinal Fixation System is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate devices of the type currently marketed in the U.S.
Conclusion:
Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate devices and effective when used as intended.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DIO Medical Co., Ltd. % Kodent, Inc. Ms. April Lee 325 N. Puente Street, Unit B Brea, California 92821
JUL 2 1 2011
Re: K11362
Trade/Device Name: Rexious Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: June 22, 2011 Received: July 05, 2011
Dear Ms. Lee:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. April Lee
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reportal":htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
s,
Fce
kerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(K) Number (if known): KIII362
Device Name: Rexious Spinal Fixation System
Indication for Use:
The Rexious Spinal Fixation System is a posterior 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 sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Rexious Spinal Fixation System is intended to provide immobilization 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Prescription Use
AND/OR
Over-The-Counter
(Part 21 CFR 801 Subpart D)
(Per 21 CFR 801 Subpart C)
.. ...
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIII 36 2 510(k) Number