(29 days)
Not Found
No
The device description and intended use focus on the mechanical components and function of a spinal fixation system. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is a pedicle fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, treating acute and chronic instabilities or deformities of the spine. This active intervention to stabilize and promote fusion in the body for medical conditions classifies it as a therapeutic device.
No
Explanation: The ANAX™ 5.5 Spinal System is described as a "posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments" and is a "multiple component, posterior spinal fixation system." Its function is to "stabilize and promote spinal fusion," which indicates it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description explicitly states it 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," and that these components are "fabricated from medical grade titanium alloy" and "cobalt-chromium-molybdenum alloy." This clearly indicates a physical hardware device, not software only.
Based on the provided text, the ANAX™ 5.5 Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The ANAX™ 5.5 Spinal System is a surgical implant intended to provide mechanical support and stabilization to the spine. It is implanted directly into the patient's body.
The description clearly states its purpose is to provide "immobilization and stabilization of spinal segments" and is a "posterior spinal fixation system." This is a description of a surgical implant, not a device used for in vitro testing of biological samples.
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:
- 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
Product codes (comma separated list FDA assigned to the subject device)
NKB
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No mechanical testing was conducted on the subject device because no new worst case is being introduced. However, the mechanical strength was evaluated theoretically by comparing data of the subject device to the ANAX™ 5.5 Spinal System (K162189, K143417, K132101) to verify there are no new safety and effectiveness issues were not raised by the subject device.
The data met all acceptance criteria and verifies that performance of the ANAX™ 5.5 Spinal System is substantially equivalent to the predicate device.
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.
ANAX™ 5.5 Spinal System (K162189), ANAX™ 5.5 Spinal System (K143417, K132101)
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
December 13, 2017
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
U&I Corporation Jee Ae Bang RA Assistant Manager 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, 11781 Korea
Re: K173524
Trade/Device Name: ANAX 5.5TM Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw Systems Regulatory Class: Class II Product Code: NKB Dated: November 13, 2017 Received: November 14, 2017
Dear Jee Ae Bang:
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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -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) K173524
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:
-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
| 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: | Jee Ae Bang, RA Assistant Manager
+82-31-860-6846
bbangzhi@youic.com |
| Date Prepared: | November 13, 2017 |
| Device Name: | Trade Name: ANAX™ 5.5 Spinal System |
| Classification Name: | Thoracolumbosacral Pedicle Screw System,
Class II per 21 CFR 888.3070 |
| Common Name: | Thoracolumbosacral Pedicle Screw System |
| Product Code: | NKB |
| Predicate Device: | ANAX™ 5.5 Spinal System (K162189) [Primary]
ANAX™ 5.5 Spinal System (K143417, K132101) |
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.
Indications for Use:
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) o
- o Spinal stenosis
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) o
- Tumor o
- Pseudoarthrosis ●
- Failed previous fusion o
Substantial Equivalence:
ANAX™ 5.5 Spinal System is substantially equivalent to the ANAX™ 5.5 Spinal System (K162189, K143417, K132101) in design, material, mechanical performance, function and intended use.
The mechanical performance of ANAX™ 5.5 Spinal System met the acceptance criteria which have been established from the predicate device.
1. Comparison Technological Characteristics
The predicate and proposed device has the similar intended use and basic fundamental scientific technology and shares the following similarities;
5
- Same indications for use o
- Similar design features
- Same materials
- Equivalent mechanical performance
2. Performance Justification
No mechanical testing was conducted on the subject device because no new worst case is being introduced. However, the mechanical strength was evaluated theoretically by comparing data of the subject device to the ANAX™ 5.5 Spinal System (K162189, K143417, K132101) to verify there are no new safety and effectiveness issues were not raised by the subject device.
The data met all acceptance criteria and verifies that performance of the ANAX™ 5.5 Spinal System is substantially equivalent to the predicate device.
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.