(134 days)
No
The device description and performance studies focus solely on the mechanical components and structural integrity of the spinal fixation system. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is described as providing "immobilization and stabilization of spinal segments" and is used to treat various "acute and chronic instabilities or deformities." This directly addresses and mitigates the impact of diseases/injuries on the body.
No
The device is a spinal fixation system intended for immobilization and stabilization of spinal segments, not for diagnosing conditions.
No
The device description explicitly details physical components made of titanium and cobalt-chromium alloys, and the performance studies are mechanical tests on these physical components.
Based on the provided text, the ANAX™ 5.5 SPINAL SYSTEM is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "posterior, non cervical 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 physical components like pedicle screws, rods, and connectors made from medical-grade alloys. These are all components of a surgical implant, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ANAX™ 5.5 SPINAL SYSTEM is a surgical implant used for structural support and stabilization within the body.
N/A
Intended Use / Indications for Use
The ANAX™ 5.5 SPINAL SYSTEM is a posterior, non cervical 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 Innosys Co., Ltd.. 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. The purpose of this submission is to add uniplanar screws and connectors to the ANAX™ 5.5 Spinal System.
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)
The mechanical strength evaluation was conducted to compare data of the proposed device of the ANAX™ 5.5 Spinal System and predicate device (K173524, K162189, K143417, K132101) to verify there are no new safety and effectiveness issues were not raised by the proposed device. The data meet all acceptance criteria and verify that the performance of the ANAX™ 5.5 Spinal System is substantially equivalent to the predicate device.
The following tests were performed:
- (1) Static compression bending test according to ASTM F1717
- (2) Static torsion test according to ASTM F1717
- (3) Compression bending fatigue test according to ASTM F1717
- (4) Axial gripping capacity test according to ASTM F1798
- (5) Axial torque gripping capacity test according to ASTM F1798
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 (K173524, K162189, 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.
OPTIMA™ Spinal System(K024096), Synergy™ Spinal System - Synergy VLS Screw(K011437), Fixpine II System(K100765)
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
October 26, 2023
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Innosys Co., Ltd. Hye-Kyung Lee RA Specialist 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si. Gyeonggi-do 11781 Korea. South
Re: K231737
Trade/Device Name: ANAXTM 5.5 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: September 26, 2023 Received: September 27, 2023
Dear Hye-Kyung 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2023.10.26
12:29:22 -04'00'
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231737
Device Name ANAX™ 5.5 Spinal System
Indications for Use (Describe)
The ANAX™ 5.5 SPINAL SYSTEM is a posterior, non cervical 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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3
510(k) Summary
| Manufacturer: | Innosys Co., Ltd.
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
Korea, 11781 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Innosys Co., Ltd.
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
Korea, 11781 |
| Sponsor Contact: | Hye-Kyung Lee, Regulatory Affairs Specialist
+82 31-860-6839
hklee@inno-sys.net |
| Date Prepared: | June 12, 2023 |
| Device Name: | Trade Name: ANAX™ 5.5 Spinal System |
| Classification Name: | Thoracolumbosacral Pedicle Screw System,
per 21 CFR 888.3070 |
| Common Name: | Thoracolumbosacral Pedicle Screw System |
| Product Code: | NKB |
| Primary Predicate
Device: | ANAX™ 5.5 Spinal System (K173524, K162189, K143417, K132101) |
| Additional Predicates: | OPTIMA™ Spinal System(K024096)
Synergy™ Spinal System - Synergy VLS Screw(K011437)
Fixpine II System(K100765) |
Description of Device:
The ANAX™ 5.5 Spinal System is manufactured by Innosys Co., Ltd.. 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
innosys
4
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. The purpose of this submission is to add uniplanar screws and connectors to the ANAX™ 5.5 Spinal System.
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) .
- 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 (K173524, 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.
Image /page/4/Picture/16 description: The image shows the logo for "innosys". The word "inno" is in blue, and the word "sys" is in orange. The font is sans-serif and bold.
5
1. Comparison Technological Characteristics
The predicate and proposed device have the similar intended use and basic fundamental scientific technology and share the following similarities;
- Same indications for use
- Similar design features
- Incorporate the same materials
- Equivalent mechanical performance
2. Performance Testing
The mechanical strength evaluation was conducted to compare data of the proposed device of the ANAX™ 5.5 Spinal System and predicate device (K173524, K162189, K143417, K132101) to verify there are no new safety and effectiveness issues were not raised by the proposed device. The data meet all acceptance criteria and verify that the performance of the ANAX™ 5.5 Spinal System is substantially equivalent to the predicate device.
The following tests were performed:
- (1) Static compression bending test according to ASTM F1717
- (2) Static torsion test according to ASTM F1717
- (3) Compression bending fatigue test according to ASTM F1717
- (4) Axial gripping capacity test according to ASTM F1798
- (5) Axial torque gripping capacity test according to ASTM F1798
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.