(132 days)
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 for "treatment of severe Spondylolisthesis" and "provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities." This indicates a therapeutic intended use.
No
The device is a pedicle screw system intended for immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosis.
No
The device description explicitly states it consists of physical components like pedicle screws, rods, bolts, and a transverse linking mechanism, fabricated from titanium alloy. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The 4STM SPINAL SYSTEM is a surgical implant system consisting of screws, rods, and other components. Its intended use is to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions. It is a physical device implanted in the body, not used to examine specimens outside the body.
The description clearly indicates a surgical implant system used in vivo (within the living body) for structural support and stabilization, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The 4STM SPINAL SYSTEM is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the 4STM SPINAL SYSTEM is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Product codes
MNI, MNH, KWQ
Device Description
The 4STM SPINAL SYSTEM is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, bolt, and a transverse (cross) linking mechanism.
The 4STM SPINAL SYSTEM will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The 4STM SPINAL SYSTEM implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4STM SPINAL SYSTEM.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L5-S1 vertebra (L3 to sacrum), 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)
Mechanical testing as listed in APPENDIX 10 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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K063708
Page 1 of 2
APR 2 4 2007
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
Submission Information
| US Agent: | Herman Oosterwijk
2001 East Oakshores Drive Aubrey, TX 76227 USA | | | | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Official Correspondent: | Gil-Woon Choi
204, Namdong Industrial-Complex, 45B-6L, #435-6,
Nonhyun-dong, Namdong-gu, Incheon, 405-848,
Republic of Korea | | | | |
| Sponsor: | TAE YEON MEDICAL CO.,LTD.
204, Namdong Industrial-Complex, 45B-6L, #435-6,
Nonhyun-dong, Namdong-gu, Incheon, 405-848,
Republic of Korea | | | | |
| Manufacturing Site | TAE YEON MEDICAL CO.,LTD.
204, Namdong Industrial-Complex, 45B-6L, #435-6,
Nonhyun-dong, Namdong-gu, Incheon, 405-848,
Republic of Korea | | | | |
Device Identification
| Trade Name: | 4S TM SPINAL SYSTEM |
|---|---|
| Common Name: | Pedicle Screw Spinal Fixation System |
| Classification Name: | Spondylolisthesis Spinal Fixation Device System(MNH) |
| per 21 CFR § 888.3070, | |
| Spinal Pedicle Screw(MNI) per 21 CFR § 888.3070 |
Substantially Equivalent Predicate Legally Marketed Devices
The subject device, 4STM SPINAL SYSTEM, is substantially equivalent in function, design, composition, material and intended used to: Global Spinal Fixation System(K001668) and OPTIMA™, Spinal System(K031585)
Device Description
The 4STM SPINAL SYSTEM is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, bolt, and a transverse (cross) linking mechanism.
TAE YEON MEDICAL CO.,LTD.
1
The 4STM SPINAL SYSTEM will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The 4STM SPINAL SYSTEM implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4STM SPINAL SYSTEM.
Indications for Use
The 4STM SPINAL SYSTEM is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bon graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the 4STM SPINAL SYSTEM is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Performance Data
Mechanical testing as listed in APPENDIX 10 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard APR 2 4 2007 Rockville MD 20850
Tae Yeon Medical Company, Limited Company c/o Mr. Gil-Woon Choi President 204, Namdong Industrial Complex, 45B-6L, #435-6 Nonhyundong, Namdong-gu, Incheon, 405-848 Republic of Korea
K063708 Trade/Device Name: 4S Spinal System Regulation Number: 21 CFR §888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNI, MNH, KWQ Dated: March 16, 2007 Received: March 26, 2007
Dear Mr. Choi:
Re:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Gil-Woon Choi
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FIEASE be advised that 1 27 is issually of 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 I caran suitates and regulding, but not limited to: registration and listing (21 CFR Part 807); labeling Act 3 requirements, merading bactice requirements as set forth in the quality systems (QS) (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with are n yourse FDA finding of substantial equivalence of your device to a legally promatics nedicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you attent office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, Echolar information on your Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2063708
Page 1 of 1
Indications for Use
5 l 0(k) Number (if known):
Device Name:
4S™ SPINAL SYSTEM
Indications for Use:
The 4STM SPINAL SYSTEM is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the 4STM SPINAL SYSTEM is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olabare Buelunp for Mon
(Bill) S. 28
and Neurological Devic
510(k) Number K063708
TAE YEON MEDICAL CO.,LTD.
4S™ SPINAL SYSTEM