(105 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are non-clinical mechanical tests.
Yes
The device aids in the immobilization of spinal segments as an adjunct to fusion, treating various spinal conditions like degenerative disc disease, fractures, and deformities, which are therapeutic applications.
No
This device is a spinal fixation system intended to provide immobilization of spinal segments as an adjunct to fusion. It is a surgical implant designed for treatment, not for diagnosing medical conditions.
No
The device description explicitly states it is a "multiple component, posterior system" consisting of "top loading polyaxial pedicle screw, which, when used with rods and crosslinks." This describes physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a spinal fixation system used to provide immobilization of spinal segments as an adjunct to fusion. This is a surgical implant used in vivo (within the body) to treat structural issues of the spine.
- Device Description: The description details a system of screws, rods, and crosslinks, which are physical components implanted into the spine.
- 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 treatment. IVDs typically involve tests performed in vitro (outside the body).
The device is a surgical implant used for orthopedic purposes, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Coligne GII Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The GII Spinal Fixation System is intended for use in the non-cervical posterior spine, in skeletally-mature patients, as an adjunct to fusion using autograft and/or allograft, the GII Spinal Fixation System is intended for use or more of the following; (1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal stenosis, (6) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis).
When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Coligne GII Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/or trauma.
This system is intended to be used with autograft. Pediatic pedicle screw fixation is limited to a posterior approach.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The GII Spinal Fixation System is a top loading polyaxial pedicle screw, which, when used with rods and crosslinks, results in a multiple component, posterior system. All the components are available in a variety of sizes to match the patient's anatomy more closely.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical posterior spine, thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients, pediatric 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 following tests were performed in support of this Special 510(k):
-
- Dynamic flexion-extension per ASTM F1798
- Torsional strength of screw/screwdriver interface 2.
The testing showed that the flexStaas pedicle screws of the GII Spinal Fixation System met or exceeded acceptance criteria.
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.
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.
Not Found
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.
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May 19, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Coligne AG % J.D. Webb President The OrthoMedix Group, Inc. 4313 W. 3800, S. West Haven, Utah 84401
Re: K210306
Trade/Device Name: GII Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: April 14, 2021 Received: April 21, 2021
Dear J.D. Webb:
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. 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 located 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.
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
1
801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210306
Device Name GII Spinal Fixation System
Indications for Use (Describe)
The Coligne GII Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The GII Spinal Fixation System is intended for use in the non-cervical posterior spine, in skeletally-mature patients, as an adjunct to fusion using autograft and/or allograft, the GII Spinal Fixation System is intended for use or more of the following; (1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal stenosis, (6) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis).
When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Coligne GII Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/or trauma.
This system is intended to be used with autograft. Pediatic pedicle screw fixation is limited to a posterior approach.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Coligne AG is hereby submitting this 510(k) Summary.
1. Date Prepared
May 18, 2021
2. Submitter [510(k) owner]
Coligne AG Utoquai 43 8008 Zurich, SWITZERLAND Phone: 41-43-3438000
3. Primary Contact
J.D. Webb 4313 W. 3800 S West Haven, UT 84401 512-590-5810 Tele e-mail: jdwebb@orthomedix.net
4. Submitted Device Information
Trade Name: GII Spinal Fixation System Common Name: pedicle screw
5. Classification Information
Classification: Class II Classification Regulation: 21 CFR 888.3070; Thoracolumbosacral pedicle screw system Classification Product Code: NKB Device Panel: Orthopedic
6. Reason for Submission
The reason for the current 510(k) is to add the flexStaas pedicle screws to the GI Spinal Fixation System.
7. Legally Marketed Predicate Devices
The flexStaas pedicle screws of the GII Spinal Fixation System manufactured by Coligne AG are substantially equivalent to the following devices currently in commercial use:
Primary Predicate Device
Device: GII-Ti-Poly-Axial Screw Company: Coligne AG 510(k) number: K083567
Additional Predicate Devices
Device: GII Spinal Fixation System Company: Coligne AG 510(k) number: K032604 Device: CD Horizon Spinal System Company: Medtronic 510(k) number: K202771
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8. Submitted Device Description
The GII Spinal Fixation System is a top loading polyaxial pedicle screw, which, when used with rods and crosslinks, results in a multiple component, posterior system. All the components are available in a variety of sizes to match the patient's anatomy more closely.
9. Materials
Ti-6AI-4V ELI (ISO 5832-3)
10.Indications for Use
The Coligne GII Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The GI Spinal Fixation System is intended for use in the noncervical posterior spine, in skeletally-mature patients, as an adjunct to fusion using autograft, the GII Spinal Fixation System is intended for use or more of the following: (1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal stenosis, (6) deformities or curvatures (i.e. scoliosis, and/or lordosis), (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis).
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Coligne GII Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/or trauma.
This system is intended to be used with autograft. Pediatic pedicle screw fixation is limited to a posterior approach.
11.Substantial Equivalence
The flexStaas pedicle screws of the GII Spinal Fixation System are substantially equivalent to the predicate devices in terms of intended use, design, manufacturing materials, principles of operation, and technical characteristics, and raises no new issues of safety or effectiveness.
12. Summary of the Technological Characteristics Compared to Predicate
Intended Use
The flexStaas pedicle screws of the GII Spinal Fixation System and the predicates are intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Materials
The flexStaas pedicle screws of the GI Spinal Fixation System use the same material as the predicates.
Design
The flexStaas pedicle screws of the GII Spinal Fixation System and the predicates are equivalent in terms of shape and function.
Dimensions
The flexStaas pedicle screws of the GI Spinal Fixation System and the predicates are equivalent in their dimensions.
Strength
The flexStaas pedicle screws of the GII Spinal Fixation System have greater or equivalent strength values compared to the predicates.
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13.Non-clinical Test Summary
The following tests were performed in support of this Special 510(k):
-
- Dynamic flexion-extension per ASTM F1798
- Torsional strength of screw/screwdriver interface 2.
The testing showed that the flexStaas pedicle screws of the GII Spinal Fixation System met or exceeded acceptance criteria.
14. Clinical Test Summary
No clinical studies were performed.
15. Conclusions: Non-clinical and Clinical
Coligne AG considers the flexStaas pedicle screws of the GII Spinal Fixation System to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials, and indications for use.