(29 days)
Not Found
No
The device description and performance studies focus on mechanical components and their physical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML. The submission is for minor modifications and size expansions of existing hardware.
Yes
Explanation: The device is an internal fixation device for spinal surgery intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities of the spine, which falls under the definition of a therapeutic device.
No
The device is an internal fixation device for spinal surgery, intended to provide immobilization and act as an adjunct to fusion. It does not state that it diagnoses conditions.
No
The device description explicitly states it consists of physical components like rods, screws, connectors, and manual instruments, all made of various materials. It is a hardware-based 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 states that the device is an internal fixation system for spinal surgery, used to immobilize spinal segments as an adjunct to fusion. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details rods, screws, connectors, and surgical instruments. These are all physical components used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
Therefore, the Ingenix™ Spinal System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Ingenix™ Spinal System is intended to provide immobilization of spinal segments in skeletal y mature patients as an adjunct to fusion in the treatment of the following acute and chromic instabilities of thoracic, lumbar, and sacral spine; degenerative spondylolisthesis, with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra with autogenous bone graft, and failed previous fusion (pseudarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The Ingenix™ Spinal System (originally cleared as "Arisstos Spinal System") is an internal fixation device for spinal surgery consisting of rods, screws, and connectors available in various sizes to accommodate patient anatomy. A series of manual instruments intended to assist in the insertion and placement of the implants, such as taps, drivers, and rod benders, is provided in separate instrument trays.
The subject rods, screws, and connectors are manufactured of Ti-6Al-4V titanium alloy per ASTM F136. Additionally, 5.5mm and 6.0mm cobalt chrome rods are also available, conforming to ASTM F1537. All instruments are manufactured from stainless steel, aluminum, and select polymers.
The subject submission seeks to gain clearance for the following:
- . Minor modifications made to screws
- . Size expansion for the polyaxial deformity screws
- . Sterile packaging of a kit configuration
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine; L5-S1 vertebra
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)
The following bench performance testing has been conducted on the subject screws per ASTM F1798-13: Static axial grip, Flexion-extension moment, and Flexion-extension fatigue. All testing showed that the subject devices performed substantially equivalent to predicate devices. Additionally, cleaning, sterilization, and packaging validations have been performed with the subject devices meeting or exceeding all 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.
0
June 4, 2024
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ingenium Spine % Christine Scifert Partner MRC Global, LLC 9085 East Mineral Circle Suite 110 Centennial, Colorado 80112
Re: K241258
Trade/Device Name: Ingenix Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: May 3, 2024 Received: May 6, 2024
Dear Christine Scifert:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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,
Eileen
Cadel -S
Digitally signed by
Eileen Cadel -S
Date: 2024.06.04
14:29:00 -04'00'
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K241258
Device Name Ingenix Spinal System
Indications for Use (Describe)
The Ingenix™ Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of the following acute and chromic instabilities of thoracic, lumbar, and sacral spine; degenerative spondylolisthesis, with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra with autogenous bone graft, and failed previous fusion (pseudarthrosis).
| 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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3
510(k) Summary
Ingenix Spinal System 3 June 2024
| Company: | Ingenium Spine |
|---|---|
| 1255 W Rio Salado Parkway #107 | |
| Tempe, AZ 85281 | |
| Phone: | (602) 281-7965 |
Primary Contact: Christine Scifert – Partner MRC Global 9085 E. Mineral Cir., Suite 110 Centennial, CO 80112 Phone: (901) 831-8053 Email: christine.scifert@AskMRCGlobal.com
| Company Contact: | David Brumfield
VP R&D
Ingenium Spine
901-277-7381
Dbrumfield911@gmail.com |
| ------------------ | ---------------------------------------------------------------------------------------- |
|---|
| Trade Name: | Ingenix Spinal System |
|---|---|
| Common Name: | Thoracolumbosacral pedicle screw system |
| Classification: | Class II |
| Regulation: | 21 CFR 888.3070 (Thoracolumbosacral pedicle screw system |
| Panel: | Orthopedic |
| Product Code: | NKB |
Device Description:
The Ingenix™ Spinal System (originally cleared as "Arisstos Spinal System") is an internal fixation device for spinal surgery consisting of rods, screws, and connectors available in various sizes to accommodate patient anatomy. A series of manual instruments intended to assist in the insertion and placement of the implants, such as taps, drivers, and rod benders, is provided in separate instrument trays.
The subject rods, screws, and connectors are manufactured of Ti-6Al-4V titanium alloy per ASTM F136. Additionally, 5.5mm and 6.0mm cobalt chrome rods are also available, conforming to ASTM F1537. All instruments are manufactured from stainless steel, aluminum, and select polymers.
4
The subject submission seeks to gain clearance for the following:
- . Minor modifications made to screws
- . Size expansion for the polyaxial deformity screws
- . Sterile packaging of a kit configuration
Indications for Use:
The Ingenix™ Spinal System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis, with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra with autogenous bone graft, and failed previous fusion (pseudarthrosis).
Substantial Equivalence:
The subject Ingenix™ Spinal System is substantially equivalent to the following predicate devices: Primary Predicate:
- . Ingenium Arisstos™ Spinal System – K173126
The subject components are identical in indications, similar in sizing and geometry, technological characteristics, and identical in materials to the predicate. The only substantial difference between the subject device and predicate device is that the subject device is provided sterile via Ethylene Oxide sterilization and the predicate device is provided non-sterile.
Performance Testing:
The following bench performance testing has been conducted on the subject screws per ASTM F1798-13: Static axial grip, Flexion-extension moment, and Flexion-extension fatigue. All testing showed that the subject devices performed substantially equivalent to predicate devices. Additionally, cleaning, sterilization, and packaging validations have been performed with the subject devices meeting or exceeding all acceptance criteria.
Conclusion:
Based on the performance analysis and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.