(139 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "posterior spinal fixation system" intended to treat various spinal conditions such as degenerative disc disease, spondylolisthesis, and spinal stenosis. These are medical conditions that affect the body's structure and function, and the device is used to alleviate or correct them.
No
This device is a spinal fixation system, surgically implanted to treat various spinal conditions. Its described purpose is therapeutic fixation, not diagnostic assessment of a condition.
No
The device description clearly states it is a "top-loading posterior spinal fixation system which consists of hooks, rods, set screws, connectors and a transverse link system," all of which are physical hardware components.
Based on the provided information, the Rexious Hook System 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 (like blood, urine, tissue) to provide information about a person's health.
- Rexious Hook System Function: The description clearly states that the Rexious Hook System is a "posterior spinal fixation system" consisting of implants (hooks, rods, etc.) made of titanium alloy. Its intended use is for surgical implantation to stabilize the spine in various conditions.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze biological samples or provide diagnostic information. Its function is purely mechanical and structural within the body.
Therefore, the Rexious Hook System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Rexious Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Rexious Hook System can be used in conjunction with the Rexious Spinal Fixation System.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The Rexious Hook System is a top-loading posterior spinal fixation system which consists of hooks, rods, set screws, connectors and a transverse link system. The Rexious Hook System implant components are fabricated from titanium alloy (Ti6A14V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The Rexious Hook System can be used in the posterior plane providing unilateral modes of fixation.
The Rexious Hook System design allows adjustment in both the sagittal and coronal planes permitting hook placement according to the best possible anatomic location and orientation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical, nonpedicle, posterior spine
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)
Performance tests per ASTM F1717 such as static compression bending, static tension, static torsion, and dynamic compression tests were submitted to characterize the subject Rexious Hook System components addressed in this notification.
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
§ 888.3050 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
MAR 2 8 2012
K11 3324
page 1 of 2
510(k) Summary
As specified under 21 CFR 807.92,
Submitter:
DIO Medical Co., Ltd. Sung-Hee Lee 103~105 Megacenter, SK Technopark 190-1 Sangdaewon-dong, Jungwon-guSungnam-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 Santa Fe Springs, CA 90670 Email; kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-0116
Device Information
Trade Name: RexiousHook System Classification Name: Spinal Interlaminal Fixation Orthosis Product Code: KWP Regulation Number: 888.3050 Date Prepared: 3/21/2012
General Description
The Rexious Hook System is a top-loading posterior spinal fixation system which consists of hooks, rods, set screws, connectors and a transverse link system. The Rexious Hook System implant components are fabricated from titanium alloy (Ti6A14V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The Rexious Hook System can be used in the posterior plane providing unilateral modes of fixation.
The Rexious Hook System design allows adjustment in both the sagittal and coronal planes permitting hook placement according to the best possible anatomic location and orientation.
Indication for Use
r
The Rexious Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Rexious Hook System can be used in conjunction with the Rexious Spinal Fixation System.
1
K113324
page 2 of 2
Materials:
The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO Standards.
Performance Data:
Performance tests per ASTM F1717 such as static compression bending, static tension, static torsion, and dynamic compression tests were submitted to characterize the subject Rexious Hook System components addressed in this notification.
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
*U&I America, Spinal Hook System™ (K031595)
Comparison to Predicate Devices:
The Substantial equivalence of this device is based on equivalence in intended use, material, designs, and operational principles to the predicate device, U&I America, Spinal Hook System™ (K031595).
Conclusion
Both the performance testing and comparison to predicate device demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol on the right side. On the left side of the logo, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
DIO Medical Co., Ltd. % Kodent Incorporated Ms. April Lee 325 North Puente Street, Unit B Brea, California 92821
MAR 2 8 2012
Re: K113324
Trade/Device Name: Rexious Hook System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: March 22, 2012 Received: March 26, 2012
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 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
3
Page 2 - Ms. April Lee
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/ReportaProblem/default.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 yours,
For
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(K) Number (if known):
Device Name: Rexious Hook System
Indication for Use:
The Rexious Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Rexious Hook System can be used in conjunction with the Rexious Spinal Fixation System.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter
(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) |
|---|
| Page 1 of 1 |
(Diysion Sign-Ori) Difision of Surgical Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________