(255 days)
Not Found
No
The summary describes a mechanical implant system for spinal fixation and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML.
Yes
Explanation: The device is intended to provide immobilization and stabilization of spinous processes to support fusion for conditions such as degenerative disc disease, trauma, and tumor, which directly addresses a health condition.
No
Explanation: The Benefix™ Interspinous Fixation System is described as a "posterior, non-pedicle supplemental fixation device" intended for "immobilization and stabilization of the spinous processes to support fusion," and not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of physical components (barrels, plates, and set screws) made of titanium alloy, which are implanted into the spine. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Benefix™ System Function: The Benefix™ Interspinous Fixation System is a surgical implant designed to provide structural support and stabilization to the spine during fusion. It is physically implanted into the patient's body.
- Lack of Specimen Analysis: The description clearly states the device's purpose is mechanical fixation to the spinous processes. There is no mention of analyzing any biological specimens.
Therefore, based on the provided information, the Benefix™ Interspinous Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Benefix™ Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. Benefix™ Interspinous Fixation System is intended for use with bone graft material and is not intended for stand-alone use.
Product codes (comma separated list FDA assigned to the subject device)
PEK
Device Description
Benefix™ Interspinous Fixation System is manufactured by U&I Corporation. The System consists of various barrels, plates, and set screws. All implant components are made of titanium alloy in accordance with ASTM F136. Benefix™ Interspinous Fixation System is intended to provide immobilization and stabilization of the spinous processes to support fusion. The components can be assembled in a various configurations so that adaptations can be made to take into pathology and individual patient anatomy. All implants are intended for single use only and should not be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1), spinous processes
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)
Benefix™ Interspinous Fixation System was tested in a non-clinical setting (bench testing), and the test results demonstrated that the Benefix™ Interspinous Fixation System is substantially equivalent to the predicate devices.
The following tests were performed:
- (1) Static compression bending test using a modified version of ASTM F1717
- (2) Static torsion test using a modified version of ASTM F1717.
- (3) Compression bending fatigue test using a modified version of ASTM F1717
- (4) Spike pull-off test
- (5) Locking mechanism strength test
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.
X-Spine Systems AXLETM Interspinous Fusion System (K130438), Medtronic CD Horizon SPIRETM Stabilization System (K043053), Lanx AspenTM Spinous Process System (K090252)
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2015
U & I Corporation Mr. Young-Geun Kim Regulatory Affairs Specialist 20, Sandan-ro 76 beon-gil (Road) Uijeongbu-si, Gyeonggi-do Republic of Korea 480-859
Re: K143631
Trade/Device Name: Benefix™ Interspinous Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: August 17, 2015 Received: August 19, 2015
Dear Mr. Kim:
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
1
Page 2 - Mr. Young-Geun Kim
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143631
Device Name Benefix™ Interspinous Fixation System
Indications for Use (Describe)
Benefix™ Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. Benefix™ Interspinous Fixation System is intended for use with bone graft material and is not intended for stand-alone use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Manufacturer: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
Korea, 480-859 |
|------------------------|-----------------------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
Korea, 480-859 |
| Sponsor Contact: | Young-Geun Kim, Regulatory Affairs Specialist
+82 31 860 6836
ygkim@youic.com |
| Date Prepared: | Aug 17, 2015 |
| Trade Name: | BenefixTM Interspinous Fixation System |
| Device Classification: | Class II |
| Classification Name: | Spinal interlaminal fixation orthosis, per 21 CFR 888.3050 |
| Common Name: | Spinous Process Plate |
| Product Code: | PEK |
| Primary Predicate: | X-Spine Systems AXLETM Interspinous Fusion System
(K130438) |
| Additional Predicates: | Medtronic CD Horizon SPIRETM Stabilization System
(K043053)
Lanx AspenTM Spinous Process System (K090252) |
Description of Device:
Benefix™ Interspinous Fixation System is manufactured by U&I Corporation. The System consists of various barrels, plates, and set screws. All implant components are made of titanium alloy in accordance with ASTM F136. Benefix™ Interspinous Fixation System is intended to provide immobilization and stabilization of the spinous processes to support fusion. The components can be assembled in a various configurations so that adaptations can be made to take into pathology and
Image /page/3/Picture/5 description: The image shows the logo for U&I Corporation. The logo features the letters "U&I" in a bold, sans-serif font, with the "I" having a red square above it. To the right of the letters, the word "CORPORATION" is written in a smaller, sans-serif font.
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individual patient anatomy. All implants are intended for single use only and should not be reused under any circumstances.
Indications for Use:
Benefix™ Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. Benefix™ Interspinous Fixation System is intended for use with bone graft material and is not intended for stand-alone use.
Substantial Equivalence:
Benefix™ Interspinous Fixation System is substantially equivalent to AXLE™ Interspinous Fusion System, CD Horizon SPIRE™ Stabilization System, Aspen™ Spinous Process System in design, material, mechanical performance, function and intended use.
Benefix™ Interspinous Fixation System has an extension design that is similar to AXLE ! Interspinous Fusion System. Benefix™ Interspinous Fixation System is relying on AXLE™ Interspinous Fusion, which has the same intended use as the Benefix™ Interspinous Fixation System, to support substantial equivalence with respect to technological characteristics.
1. Comparison of Technological Characteristics
The predicates and proposed device have the similar intended use and basic fundamental scientific technology and share the following similarities;
- The similar indications for use
- Similar design features
- Incorporate the same or similar materials
- The equivalent mechanical performance
Image /page/4/Picture/12 description: The image shows the logo for U&I Corporation. The logo features the letters "U&I" in a bold, sans-serif font, with the "i" having a red square above it. To the right of the letters, the word "CORPORATION" is written in a smaller, sans-serif font.
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2. Performance Testing
Benefix™ Interspinous Fixation System was tested in a non-clinical setting (bench testing), and the test results demonstrated that the Benefix™ Interspinous Fixation System is substantially equivalent to the predicate devices.
The following tests were performed:
- (1) Static compression bending test using a modified version of ASTM F1717
- (2) Static torsion test using a modified version of ASTM F1717.
- (3) Compression bending fatigue test using a modified version of ASTM F1717
- (4) Spike pull-off test
- (5) Locking mechanism strength test
3. Conclusion
The data and information provided in this submission support the conclusion that the Benefix™ Interspinous Fixation System is substantially equivalent to the predicate devices.
Image /page/5/Picture/10 description: The image shows the logo for U&I Corporation. The logo is black, except for a red square above the letter "i". The words "U&I" are in a stylized font, and the word "Corporation" is in a more standard font.