(118 days)
Not Found
No
The document describes a mechanical spinal fixation system made of titanium alloy. There is no mention of software, image processing, AI, ML, or any data-driven components. The performance studies are bench tests, not clinical studies involving data analysis.
Yes.
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for treating various conditions, which are therapeutic actions.
No
The device is described as a "posterior spinal fixation device" and a "multiple component spinal fixation system" intended to provide "immobilization and stabilization of spinal segments" as an adjunct to fusion. Its purpose is mechanical support and stabilization, not to diagnose medical conditions.
No
The device description explicitly states it is comprised of "multiple component spinal fixation system comprised of variety of single-use, non-sterile devices" manufactured from titanium alloy, including "pedicle screws, set screws, rods, c.en that ochlorne to no se se (cross) linking mechanism." This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for spinal fixation and stabilization. It is a physical device implanted in the body to treat structural issues.
- Device Description: The description details the components of a spinal fixation system (screws, rods, etc.) made of titanium alloy. This aligns with a surgical implant, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Focus on Mechanical Support: The primary function described is providing immobilization and stabilization of spinal segments.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) as a therapeutic and supportive measure.
N/A
Intended Use / Indications for Use
The GLOBAL SPINAL FIXATION 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 GLOBAL SPINAL FIXATION 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
MNH, MNI
Device Description
The GLOBAL SPINAL FIXATION SYSTEM™ Spinal System is a multiple component spinal fixation system comprised of variety of single-use, non-sterile devices that allow Spirial industry of the mant construct in order to provide stabilization and promote spinal fusion. The implants are manufactured from titanium alloy, Ti-6Al-4V ELI that conforms to ASTM 136 98 and include pedicle screws, set screws, rods, c.en that ochlorne to no se se (cross) linking mechanism. Various sizes of these implants are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L5-S1 vertebra (lumbar and sacral spine, 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)
Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed 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.
0
FEB 1 7 2005
[10]
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
Submission Information:
| Contact: | Betty Lim
Regulatory Affairs | | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Sponsor: | U&i Corporation
YongHyun-Dong 529-1, Uijungbu
Kyonggi-Do, Korea 480-050
Phone: 82-31-852-0102(ext. 612)
Fax: 82-31-852-0108 | | |
| Date Prepared: | January 3, 2005 | | |
| Device Identification: | | | |
| Trade Name: | GLOBAL SPINAL FIXATION SYSTEM™ | | |
| Common Name: | Pedical Screw Spinal Fixation System | | |
| Classification Name: | Spinal Pedical Screw (MNI) per 21 CFR § 888.3070
Spondylolisthesis Spinal Fixation Device System (MNH) per 21 CFR § 888.3070 | | |
Substantially Equivalent Predicate Legally Marketed Devices:
The subject GLOBAL SPINAL FIXATION SYSTEM™ is substantially equivalent in function, design, composition, labeling, and intended use to:
GLOBAL SPINAL FIXATION SYSTEM™, Spinal System MNH, MNI - (K001668). TRIPLE-FIX Spinal Fixation System - KWP, MNH, MNI -- (K992147) 1SOLA Spinal System -- MNH, MNI, KWQ -- (K980485)
The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operational principles to the above listed predicate devices.
Page-51
Page 1 of 2
1
Device Description:
The GLOBAL SPINAL FIXATION SYSTEM™ Spinal System is a multiple component spinal fixation system comprised of variety of single-use, non-sterile devices that allow Spirial industry of the mant construct in order to provide stabilization and promote spinal fusion. The implants are manufactured from titanium alloy, Ti-6Al-4V ELI that conforms to ASTM 136 98 and include pedicle screws, set screws, rods, c.en that ochlorne to no se se (cross) linking mechanism. Various sizes of these implants are available.
Indications for Use:
The GLOBAL SPINAL FIXATION 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 GLOBAL SPINAL FIXATION 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).
Statement of Technological Comparison:
The subject spinal implant system is substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles.
Performance Data:
Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices.
Page-52
Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
FEB 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Betty Lim Regulatory Affairs U&I Corporation YongHyun-Dong 529-1, Uijungbu Kyonggi-Do, Korea 480-050
Re: K042928
Trade/Device Name: Global Spinal Fixation System™ Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI Dated: January 10, 2005 Received: January 18, 2005
Dear Ms. Lim:
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.
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): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Lim
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate 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 contact the 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, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
[5] INDICATIONS for USE STATEMENT
510(k) Number (if known): K042928
Device Name: GLOBAL SPINAL FIXATION SYSTEM™
Indications for Use: The GLOBAL SPINAL FIXATION SYSTEM™ posterior spinal fixation device 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 GLOBAL SPINAL FIXATION 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).
メ (Per 21 CFR OR Over-the-Counter Use Prescription Use 801.109) (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
|--|--|
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K042978 |
|---|---|
| --------------- | --------- |
Page 1 ofU&I Corporation Global Spinal Fixation System116 Supplementary information
Page-31