(26 days)
No
The device description focuses on mechanical components and surgical techniques, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
Explanation: The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for treating various acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, which clearly indicates a therapeutic purpose.
No
The device is a spinal fixation system designed to provide immobilization and stabilization of spinal segments, not to diagnose medical conditions.
No
The device description clearly outlines physical components such as pedicle screws, rods, set screws, connectors, and a transverse linking mechanism, all fabricated from medical-grade materials. It also mentions specialized instruments for application and removal. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the ANAX™ 5.5 Spinal System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is a "posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft." This describes a surgical implant used in vivo (within the body) to treat structural issues of the spine.
- Device Description: The description details components like pedicle screws, rods, set screws, and connectors, all of which are physical implants designed to be surgically placed within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The ANAX™ 5.5 Spinal System does not perform any such analysis of bodily specimens.
Therefore, the ANAX™ 5.5 Spinal System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The ANAX™ 5.5 Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
Spondylolithesis (Grade 3 and 4) Degenerative spondylolisthesis with objective evidence of neurological impairment Trauma (i.e., fracture or dislocation) Spinal stenosis Defomities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) Tumor Pseudoarthrosis Failed previous fusion
Product codes
MNH, MNI
Device Description
The ANAX™ 5.5 Spinal System is manufactured by U&I corporation. The ANAX™ 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of pedicle screws, rods, set screws, connectors and a transverse (cross) linking mechanism. The ANAX™ 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The ANAX™ 5.5 Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). All pedicle screws have self-tapping function in ANAX™ 5.5 spinal System. The double lead thread is applied to the all pedicle screws to shorten the operation time. ANAX™ 5.5 Spinal System with CoCr rods may be used to provide immobilization and stabilization of spinal segment when the rigid system is need. (Recommendation: trauma or deformities) The product life time of ANAX™ 5.5 SPINAL SYSTEM is 2 years based on mechanical test result.
MIS Extended Screw, Set Screw for MIS, and Straight and Curved MIS Rod have newly added in the system and they are intended for use in minimally invasive surgery (MIS).
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of ANAX™ 5.5 Spinal System implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine
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
The mechanical performance of ANAX™ 5.5 Spinal System met the acceptance criteria which have been established from the predicate devices.
Additional mechanical testing (bench testing) was not conducted on the ANAX™ 5.5 Spinal System. However, the justification report was conducted to compare data of modified device to the ANAX™ 5.5 Spinal System (K132101, K143417) and determined no new worst case was introduced.
The data met all acceptance criteria and verifies that performance of the ANAX™ 5.5 Spinal System is substantially equivalent to the predicate devices.
The data and information provided in this submission support the conclusion that the ANAX™ 5.5 Spinal System is substantially equivalent to its predicate device with respect to indications for use and technological characteristics.
Key Metrics
Not Found
Predicate Device(s)
ANAXTM 5.5 Spinal System (K132101), ANAXTM 5.5 Spinal System (K143417)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 30, 2016
U&I Corporation Ms. Ji Yea Lee Regulatory Affairs Specialist 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, Gyeonggi-do KOREA 11781
Re: K162189
Trade/Device Name: ANAX™ 5.5 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: August 2, 2016 Received: August 4, 2016
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 CFRParts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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,
Mark N. Melkerson -S
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) K162189
Device Name ANAX™ 5.5 Spinal System
Indications for Use (Describe)
The ANAX™ 5.5 Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
Spondylolithesis (Grade 3 and 4) Degenerative spondylolisthesis with objective evidence of neurological impairment Trauma (i.e., fracture or dislocation) Spinal stenosis Defomities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) Tumor Pseudoarthrosis Failed previous fusion
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Manufacturer: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do
Korea, 11781 | |
|-----------------------|----------------------------------------------------------------------------------------------|--|
| Sponsor: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do
Korea, 11781 | |
| Sponsor Contact: | Ji Yea Lee, Regulatory Affairs Specialist
+82-31-860-6837
jylee@youic.com | |
| Date Prepared: | Aug 23, 2016 | |
| Device Name: | ANAXTM 5.5 Spinal System | |
| Classification Name: | Pedicle screw spinal system, per 21 CFR 888.3070 | |
| Common Name: | Pedicle screw spinal fixation system | |
| Product Code: | MNH, MNI (Class II) | |
| Primary Predicate: | ANAXTM 5.5 Spinal System (K132101) | |
| Additional Predicate: | ANAXTM 5.5 Spinal System (K143417) | |
Description of Device:
The ANAX™ 5.5 Spinal System is manufactured by U&I corporation. The ANAX™ 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of pedicle screws, rods, set screws, connectors and a transverse (cross) linking mechanism. The ANAX™ 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The ANAX™ 5.5 Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). All pedicle screws have self-tapping function in ANAX™ 5.5 spinal System. The double lead thread is applied to the all pedicle screws to shorten the operation time. ANAX™
4
5.5 Spinal System with CoCr rods may be used to provide immobilization and stabilization of spinal segment when the rigid system is need. (Recommendation: trauma or deformities) The product life time of ANAX™ 5.5 SPINAL SYSTEM is 2 years based on mechanical test result.
MIS Extended Screw, Set Screw for MIS, and Straight and Curved MIS Rod have newly added in the system and they are intended for use in minimally invasive surgery (MIS).
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of ANAX™ 5.5 Spinal System implants.
Indications for Use:
The ANAX™ 5.5 Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
Spondylolisthesis (Grade 3 and 4) Degenerative spondylolisthesis with objective evidence of neurological impairment Trauma (i.e., fracture or dislocation) Spinal stenosis Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) Tumor Pseudoarthrosis Failed previous fusion
Substantial Equivalence:
ANAX™ 5.5 Spinal System is substantially equivalent to the ANAX™ 5.5 Spinal System (K132101, K143417) in design, material, mechanical performance, function and intended use.
5
The mechanical performance of ANAX™ 5.5 Spinal System met the acceptance criteria which have been established from the predicate devices.
1. Comparison Technological Characteristics
The predicate and proposed devices 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
2. Performance Justification
Additional mechanical testing (bench testing) was not conducted on the ANAX™ 5.5 Spinal System. However, the justification report was conducted to compare data of modified device to the ANAX™ 5.5 Spinal System (K132101, K143417) and determined no new worst case was introduced.
The data met all acceptance criteria and verifies that performance of the ANAX™ 5.5 Spinal System is substantially equivalent to the predicate devices.
3. Conclusion
The data and information provided in this submission support the conclusion that the ANAX™ 5.5 Spinal System is substantially equivalent to its predicate device with respect to indications for use and technological characteristics.