(141 days)
No
The device description and intended use clearly define a mechanical spinal fixation system with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as a "Global Spinal Fixation System" intended to provide immobilization and stabilization of spinal segments for the treatment of various spinal conditions, which aligns with the definition of a therapeutic device.
No
The device is a pedicle screw system intended for spinal fixation and fusion, which is a treatment and stabilization device, not a diagnostic one.
No
The device description explicitly states it is a "multiple component system comprised of a variety of single-use, non-sterile devices" manufactured from titanium alloy and stainless steel, including physical implants like pedicle screws, hooks, and rods. 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:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The Global Spinal Fixation System is a system of implants (pedicle screws, hooks, rods, etc.) made of titanium alloy. These are surgically implanted inside the body to stabilize the spine.
- Intended Use: The intended use describes the surgical treatment of spinal conditions by providing stabilization and promoting fusion. This is a surgical procedure, not a diagnostic test performed on a specimen.
The device is a surgical implant used for treatment, not a diagnostic tool used for testing biological samples.
N/A
Intended Use / Indications for Use
The Global Spinal Fixation System is a pedicle screw 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.
The GSFS 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 impairement, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Product codes
MNH, MNI, KWP
Device Description
The Global Spinal Fixation System (GSFS) is a multiple component system comprised of a variety of single-use, non-sterile devices that allow the surgeon to build a spinal implant construct in order to provide stabilization and promote spinal fusion. The implants are manufactured from titanium allov. Ti6A14V that conforms to ASTM 136 98 and include pedicle screws, hooks, rods, cross link, and connector. Various sizes of these implants are available. Specialized instrument made from surgical instrument grade stainless steel is available for the application and removal of the GSFS implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and sacral spine (L3 to sacrum), L5-S1 vertebra, 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)
Not Found
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
OCT 1 9 2000
Image /page/0/Picture/1 description: The image shows the logo for Dong Kwang Medical Co., Ltd. The logo consists of the letters "DKM" arranged in a cross shape on the left side. To the right of the letters is the company name in Korean characters, followed by the English translation "Dong Kwang Medical Co., Ltd."
SUNGBUK-KU DONGSUN-DONG 1GA 122 E-EUN BUILDING 602 OUL, SOUTH KOREA EL: 82.2.921.6427 / FAX: 82.2.921.6428
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
GLOBAL SPINAL FIXATION SYSTEM
510(k) No.:
Date:
COMPANY:
D.K.M. Co., Ltd Sung Buk-Ku Dong Sun-Dong 1GA 122 Dae-Eun Building, 602 Seoul, South Korea
CONTACT:
TRADE NAME:
COMMON NAME:
CLASSIFICATION NAME (CODE):
CLASSIFICATION:
REVIEW PANEL:
PERFORMANCE STANDARD:
Kyung-Tae Kim Regulatory Affairs / Project Manager Tel: 82.2.921.6427 Fax: 82.2.921.6428 uaukim@unitel.co.kr
Global Spinal Fixation System (GSFS)
Pedicle Screw Spinal Fixation System
Spinal Pedicle Screw (MNI) Spondylolisthesis Spinal Fixation Device System (MNH)
888.3070
Orthopedic Devices Branch Division of General and Restorative Devices
D.K.M. Co., Ltd. is not aware of any Special Controls or Performance Standards established for pedicle screw spinal systems under Sections 513 and 514, respectively, of the FD&C Act.
1
Image /page/1/Picture/0 description: The image shows a logo for Dong Kwang Medical Co., Ltd. The logo consists of a cross shape made of small squares on the left, followed by the text "DKM" in a stylized font. To the right of "DKM", there is Korean text that reads "CI·케미·엠 [주]". Below the Korean text is the English translation "Dong Kwang Medical Co., Ltd."
TEL: 82.2.921.6427 / FAX: 82.2.921.6428
SUBSTANTIAL EQUIVALENCE
The Global Spinal Fixation System is substantially equivalent to Advanced Spine Technology's Triple-Fix Spinal Fixation System (K992147).
DEVICE DESCRIPTION
The Global Spinal Fixation System (GSFS) is a multiple component system comprised of a variety of single-use, non-sterile devices that allow the surgeon to build a spinal implant construct in order to provide stabilization and promote spinal fusion. The implants are manufactured from titanium allov. Ti6A14V that conforms to ASTM 136 98 and include pedicle screws, hooks, rods, cross link, and connector. Various sizes of these implants are available. Specialized instrument made from surgical instrument grade stainless steel is available for the application and removal of the GSFS implants.
INDICATIONS FOR USE
The Global Spinal Fixation System is a pedicle screw 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.
The GSFS 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 impairement, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its head facing left and three stripes representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
OCT 1 9 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
D.K.M. Company, Limited c/o Mr. Andrew Paeng AP Consulting Post Office Box 3415 St. Louis. Missouri 63143
Re: K001668
Trade Name: Global Spinal Fixation System Regulatory Class: II Product Code: MNH, MNI, KWP Dated: July 31, 2000 Received: August 1, 2000
Dear Mr. Paeng:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
3
Page 2 - D.K.M. Company, Limited
If you desire specific advice for your device on our labeling regulation (21 CFF) Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at additionally 809.10 for in vito diagliostic as nothy promotion and advertising of your device, (301) 594-4039. Adultionally, for questions on as p-4639. Also, please note the regulation prease contact the Office or Comphanee as (301) of the Sony of CFR 807.97). Other general entitled, "Misbranding by relective to penial Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained (2012-442-6507 information on your responsionnes ander the no nover (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark n Melhus
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
INDICATIONS FOR USE STATEMENT
PMN 510(k) Number: K 001668
Device Name
Global Spinal Fixation System
Indications for Use
The Global Spinal Fixation System is a pedicle screw 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 GSFS 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 impairement, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Melkerson
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use _
(Optional Format 3-10-98)