(285 days)
Not Found
No
The 510(k) summary describes a spinal fixation system, which is a mechanical implant. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical equivalence to existing components.
Yes
The device is used to treat specific medical conditions, such as fractures, scoliosis, kyphosis, and spinal tumors, as an adjunct to fusion. This indicates a therapeutic intent.
No
The device is a spinal fixation system, which is an implantable medical device used to stabilize the spine, not to perform diagnosis. It is used as an "adjunct to fusion" for various spinal conditions.
No
The device description explicitly refers to "components, nuts, washers, cross-links and instrumentation" and a "new GII-Ti-Poly-Axial Screw," which are physical hardware components of a spinal fixation system.
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 system used for spinal fixation in the non-cervical posterior spine. This is a device used in vivo (within the body) to provide structural support and aid in fusion.
- Device Description: The device is described as a spinal fixation system with screws, nuts, washers, and cross-links. These are physical components implanted during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The GII spinal fixation system when used as a pedicle screw system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:
(1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S1) joint with objective evidence of neurologic impairment,
(2) Fracture,
(3) Dislocation,
(4) Scoliosis,
(5) Kyphosis,
(6) Spinal tumor, and/or
(7) Failed previous fusion (pseudoarthrosis).
The GII spinal fixation system when used as a hook and sacral/iliac screw fixation system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:
(1) Degenerative spondylolisthesis with objective evidence of neurologic impairment,
(2) Fracture,
(3) Dislocation,
(4) Scoliosis,
(5) Kyphosis,
(7) Spinal tumor, and/or
(8) Failed previous fusion (pseudoarthrosis).
Product codes
MNI, MNH, KWP
Device Description
The new GII-Ti-Poly-Axial Screw is intended to be used with the existing components, nuts, washers, cross-links and instrumentation as currently provided with the cleared GII Spinal Fixation System. The previously cleared indications for use of the GII Spinal Fixation System are unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical posterior spine, fifth lumbar/first sacral (L5-S1) joint
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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
Testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the new GII-Ti-Poly-Axial Screw performs in a manner equivalent to the existing screw components of the cleared GII Spinal Fixation System.
Key Metrics
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
Section 5: 510(k) Summary
| 510(k) Summary of Safety Information | COLIGNE AG. |
|---|---|
| Premarket Notification, Section 510(k) | JULY 23, 2009 |
Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:
-
- Device Name:
Trade Name: GII-Ti-Poly-Axial Screw Common Pedicle screw spinal system Name(s):
- Device Name:
Classification Pedicle screw spinal system Name(s):
- Establishment Name & Registration Number: 2. Name: coLigne AG. 9614472 Number:
3. Classification(s):
Sec. § 888.3070 Pedicle screw spinal system
| Device Class: | Class II for all requested indications |
|---|---|
| Classification Panel: | Orthopaedic and Rehabilitation Devices Panel |
| Product Code(s): | MNI, MNH, KWP |
4. Equivalent Predicate Device:
COLIGNE AG. believes that the GII Spinal Fixation System modified by the inclusion of the GII-Ti-Poly-Axial Screw is substantially equivalent to the screws currently offered in the GII Spinal Fixation System identified below:
K980852 - K032604 and K051089 - GII Spinal Fixation System
Equivalence can be seen in the comparable design, material composition, surgical technique, intended use and testing characteristics of the GII system and other currently marketed spinal systems.
5. Device Description:
The new GII-Ti-Poly-Axial Screw is intended to be used with the existing components, nuts, washers, cross-links and instrumentation as currently provided with the cleared GII Spinal Fixation System. The previously cleared indications for use of the GII Spinal Fixation System are unchanged.
1
Testing Summary. Testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the new GII-Ti-Poly-Axial Screw performs in a manner equivalent to the existing screw components of the cleared GII Spinal Fixation System.
Indications For Use
The GII spinal fixation system when used as a pedicle screw system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:
(1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S1) joint with objective evidence of neurologic impairment,
(2) Fracture,
(3) Dislocation,
(4) Scoliosis,
(5) Kyphosis,
(6) Spinal tumor, and/or
(7) Failed previous fusion (pseudoarthrosis).
The GII spinal fixation system when used as a hook and sacral/iliac screw fixation system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:
(1) Degenerative spondylolisthesis with objective evidence of neurologic impairment,
(2) Fracture,
(3) Dislocation,
(4) Scoliosis,
(5) Kyphosis,
(7) Spinal tumor, and/or
(8) Failed previous fusion (pseudoarthrosis).
Applicant Name & Address: 6.
coLigne AG Utoquai 43 Zurich, Switzerland 8008 41-433-438000 41-433-438009 - fax Registration Number: 9614472
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 stylized eagle with three wavy lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver-Spring, MD 20993-0002
SEP 1 4 2009
Co-Ligne AG % Buckman Company, Inc. Mr. David W. Schlerf 2800 Pleasant Hill Road Suite 175 Pleasant Hill California 94523
Re: K083567
Trade/Device Name: GH Spinal Fixation System - Ti-Poly-Axial Screw Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: July 25, 2009 Received: September 10, 2009
Dear Mr. Schlerf:
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. David W. Schlerf
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jarbare Buehr
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health ·
Enclosure
4
Page _ 1 of of l
510(k) Number : K083567
Device Name(s): GII Spinal Fixation System - Ti-Poly-Axial Screw
The GII spinal fixation system when used as a pedicle screw system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:
(1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (LS-S1) joint with objective evidence of neurologic impairment,
(2) Fracture,
(3) Dislocation,
(4) Scoliosis,
(5) Kyphosis,
(6) Spinal tumor, and/or
(7) Failed previous fusion (pseudoarthrosis).
The GII spinal fixation system when used as a hook and sacral/iliac screw fixation system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:
(1) Degenerative spondylolisthesis with objective evidence of neurologic impairment,
(2) Fracture,
(3) Dislocation,
(4) Scoliosis.
(5) Kyphosis.
(7) Spinal tumor, and/or
(8) Failed previous fusion (pseudoarthrosis).
Prescription Use X OR Over-The-Counter Use PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Kareem S. Burney for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Levices
(Optional format 1-2-96)
510(k) Number K083567
(Per 21 CFR 801.109)