(30 days)
Not Found
No
The device description and intended use describe a mechanical pedicle screw system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is described as an adjunct to fusion for various spinal conditions, indicating its role in the treatment and management of these conditions.
No
Explanation: The provided text describes a "Modular Pedicle Screw System" which is an implantable medical device used for immobilization and stabilization of the spine as an adjunct to fusion. Its purpose is therapeutic (fusion and stabilization) rather than diagnostic (identifying or characterizing a medical condition).
No
The device description explicitly lists physical components such as rods, pedicle screws, connectors, and fasteners, indicating it is a hardware-based medical device.
No, 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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a system of implants (rods, screws, connectors) intended for surgical implantation into the spine to provide structural support and stabilization. This is a surgical implant, not a device that analyzes biological samples.
The information provided focuses on the mechanical properties and surgical application of the device, which is consistent with a medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The INERTIA® CONNEXX™ Modular Pedicle Screw System is intended for immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the INERTIA® CONNEXX™ Modular Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis and congenital scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The INERTIA® CONNEXX™ Modular Pedicle Screw System is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB
Device Description
The INERTIA® CONNEXX™ Modular Pedicle Screw System consists of rods, pedicle screws, connectors and fasteners. Rods are available in either straight, or pre-contoured (curved) or revision forms in a variety of lengths. Pedicle screws are available in modular and non-modular polyaxial, and non-modular uniplanar designs having double lead standard or cortical/cancellous thread forms in a variety of diameter-length combinations. Connectors include offset, various wedding band options and transverse rod-to-rod. Set screws are used to fasten the components. The INERTIA® CONNEXX™ Modular Pedicle Screw System implants may be sold sterile or nonsterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior non-cervical spine (T1-S2/Ilium)
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)
Mechanical testing of worst case INERTIA® CONNEXX™ constructs included dynamic compression bending according to ASTM F1717. The results demonstrate that INERTIA® CONNEXX™ Modular Pedicle Screw System performance is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K153453, K223273, K090984, K101278, K132412, K141376, K221905
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.
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July 20, 2023
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Nexxt Spine LLC % Karen Warden President BackRoads Consulting Inc. PO Box 566 Chesterland, Ohio 44026
Re: K231799
Trade/Device Name: INERTIA® CONNEXX™ Modular Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: June 19, 2023 Received: June 20, 2023
Dear Karen Warden:
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
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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 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 (OS) 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 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,
Image /page/1/Picture/6 description: The image contains the name "Colin O'neill -S" on the left side of the image. On the right side of the image is the acronym "FDA" in a light blue color. The acronym is much larger than the name on the left side of the image. The background of the image is white.
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
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
INERTIA® CONNEXX™ Modular Pedicle Screw System
Indications for Use (Describe)
The INERTIA® CONNEXX™ Modular Pedicle Screw System is intended for immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatic patients, the INERTIA® CONNEXX™ Modular Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis and congenital scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The INERTIA® CONNEXX™ Modular Pedicle Screw System is to be used with autograft. Pediatric 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
| Date: | 19 June 2023 |
|---|---|
| Sponsor: | Nexxt Spine, LLC |
| 14425 Bergen Blvd, Suite B | |
| Noblesville, IN 46060 | |
| Office: 317.436.7801 | |
| Fax: 317.245.2518 | |
| Sponsor Contact: | Andy Elsbury, President |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | INERTIA® CONNEXX™ Modular Pedicle Screw System |
| Common Name: | Posterior pedicle screw system |
| Regulatory Class: | Class II |
| Regulation Name: | Thoracolumbosacral pedicle screw system |
| Regulation Number: | 21 CFR 888.3070 |
| Product Code: | NKB |
| Submission Purpose: | The subject 510(k) adds connectors and revision rod options to the |
| INERTIA® Pedicle Screw System. | |
| Device Description: | The INERTIA® CONNEXX™ Modular Pedicle Screw System consists of |
| rods, pedicle screws, connectors and fasteners. Rods are available in either | |
| straight, or pre-contoured (curved) or revision forms in a variety of lengths. | |
| Pedicle screws are available in modular and non-modular polyaxial, and | |
| non-modular uniplanar designs having double lead standard or | |
| cortical/cancellous thread forms in a variety of diameter-length | |
| combinations. Connectors include offset, various wedding band options and | |
| transverse rod-to-rod. Set screws are used to fasten the components. | |
| The INERTIA® CONNEXX™ Modular Pedicle Screw System implants may | |
| be sold sterile or nonsterile. | |
| Indications for Use: | The INERTIA® CONNEXX™ Modular Pedicle Screw System is intended for |
| immobilization and stabilization of the posterior non-cervical spine (T1- | |
| S2/Ilium) in skeletally mature patients as an adjunct to fusion for the | |
| following indications: degenerative disc disease (defined as back pain of | |
| discogenic origin with degeneration of the disc confirmed by history and | |
| radiographic studies), spondylolisthesis, trauma (i.e., fracture or | |
| dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or | |
| lordosis), tumor, pseudarthrosis, and/or failed previous fusion. | |
| When used for posterior non-cervical pedicle screw fixation in pediatric | |
| patients, the INERTIA® CONNEXX™ Modular Pedicle Screw System | |
| implants are indicated as an adjunct to fusion to treat progressive spinal | |
| deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic | |
| scoliosis, neuromuscular scoliosis and congenital scoliosis. Additionally, the | |
| system is intended to treat pediatric patients diagnosed with the following | |
| conditions: spondylolisthesis / spondylolysis, fracture caused by tumor | |
| and/or trauma, pseudarthrosis, and/or failed previous fusion. The INERTIA® | |
| CONNEXX™ Modular Pedicle Screw System is to be used with autograft | |
| and/or allograft. Pediatric pedicle screw fixation is limited to a posterior | |
| approach. | |
| Materials: | INERTIA® CONNEXX™ implants are manufactured from Ti6Al4V ELI |
| titanium alloy (ASTM F136) or cobalt chrome per ASTM F1537 (rods only). | |
| Primary Predicate: | INERTIA® Pedicle Screw and Deformity Correxxion™ System (Nexxt Spine |
| LLC - K153453) | |
| Additional Predicates: | Astra Spinal System (SpineCraft, LLC - K223273), INERTIA® Pedicle |
| Screw System (Nexxt Spine, LLC - K090984, K101278, K132412, | |
| K141376, K221905)] | |
| Performance Data: | Mechanical testing of worst case INERTIA® CONNEXX™ constructs |
| included dynamic compression bending according to ASTM F1717. The | |
| results demonstrate that INERTIA® CONNEXX™ Modular Pedicle Screw | |
| System performance is substantially equivalent to the predicate. | |
| Technological | |
| Characteristics: | The INERTIA® CONNEXX™ devices possess the same technological |
| characteristics as one or more of the predicate devices. These include: | |
| ● performance (as described above), | |
| ● basic design (rod and screw configuration), | |
| ● material (titanium alloy) and | |
| ● size (dimensions are comparable to those offered by the cleared devices). | |
| Therefore the fundamental scientific technology of the INERTIA® | |
| CONNEXX™ Modular Pedicle Screw System devices is the same as | |
| previously cleared devices. | |
| Conclusion: | The INERTIA® CONNEXX™ devices possesses the same intended use and |
| technological characteristics as the predicate devices. Therefore the | |
| INERTIA® CONNEXX™ Modular Pedicle Screw System is substantially | |
| equivalent for its intended use. |
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