(60 days)
No
The summary describes a mechanical spinal fixation system made of metal 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.
Yes
The device is described as a spinal fixation system intended to provide "immobilization of spinal segments... as an adjunct to fusion" in the treatment of various spinal instabilities and conditions, indicating a therapeutic purpose.
No
The device, the Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M™ Spinal Fixation System, is described as a "spinal fixation system" intended to provide "immobilization of spinal segments as an adjunct to fusion." Its description details components like "pedicle screws, rods, set screws," and its purpose is to "stabilize and promote spinal fusion." It is a physical implant designed for treatment, not for diagnosing conditions.
No
The device description clearly states it consists of physical components like pedicle screws, rods, set screws, etc., which are hardware implants.
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 to provide immobilization and aid in spinal fusion for various spinal conditions. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as a system of physical components (screws, rods, etc.) made of specific materials, designed to be implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Rexious Spinal Fixation System, Spinal Fixation System, and Statera-M™ Spinal Fixation System are 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 of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used for posterior non-cervical screw fixation in pediatric patients, the Rexious System, Statera™ Spinal Fixation System, and Statera-MTM System are indicated as an adjunct to fusion to treat: adolescent idiopathic scoliosis, progressive spinal deformities (i.e., scolosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, spondylolisthesis, spondylolysis, pseudarthrosis, failed prior fusion, and fracture caused by tumor and/or trauma in pediatric patients. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
When used as an anterolateral thoracolumbar system, the Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M™ Spinal Fixation System are intended for anterolateral screw (with staples) fixation for the following indications: degenerative discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
Product codes
NKB, KWP, KWQ
Device Description
The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, set screws, connectors, hooks, washers, staples, and transverse (cross) linking mechanisms.
The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The implant components are supplied non-sterile, single use and fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537. Various sizes of these implants are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine; non-cervical; thoracolumbar spine (T8-L5)
Indicated Patient Age Range
skeletally mature patients; pediatric patients (including infantile and juvenile)
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)
Non-clinical testing was performed to demonstrate that the subject Statera™ Spinal System, and Statera-M™ Spinal System are substantially equivalent to the predicate device. The following testing was performed in accordance with the ASTM F1717:
- Static compression bending
- Dynamic compression bending
- Static Torsion
The nonclinical tests demonstrate that the Statera™ Spinal System, and Statera-M™ Spinal System are substantially equivalent to the legally marketed predicate devices.
For the remaining subject devices, submission is only transferring name of a system that has already been cleared under K222415. As those subject devices are identical to the predicate devices, no performance testing is required.
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
October 24, 2023
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.
K&J Consulting Corp. Jeena Mathai 4027 Runnymeade Drive Collegeville, Pennsylvania 19426
Re: K232586
Trade/Device Name: Rexious Spinal Fixation System, Statera™ Spinal Fixation System, Statera-M™ Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: August 23, 2023 Received: August 25, 2023
Dear Jeena Mathai:
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 OS 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
Digitally signed
by Eileen Cadel -S
Date: 2023.10.24
Cadel -S 14:34:37 -04'00'
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
for
Enclosure
2
Indications for Use
510(k) Number (if known) K232586
Device Name
Rexious Spinal Fixation System, Statera™ Spinal Fixation System, Statera-M™ Spinal Fixation System
Indications for Use (Describe)
The Rexious Spinal Fixation System, Spinal Fixation System, and Statera-M™ Spinal Fixation System are 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 of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion
(pseudarthrosis).
When used for posterior non-cervical screw fixation in pediatric patients, the Rexious System, Statera™ Spinal Fixation System, and Statera-MTM System are indicated as an adjunct to fusion to treat: adolescent idiopathic scoliosis, progressive spinal deformities (i.e., scolosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, spondylolisthesis, spondylolysis, pseudarthrosis, failed prior fusion, and fracture caused by tumor and/or trauma in pediatric patients. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
When used as an anterolateral thoracolumbar system, the Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M™ Spinal Fixation System are intended for anterolateral screw (with staples) fixation for the following indications: degenerative discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
| 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
K&J Consulting
Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System
| Submitter: | K&J Consulting Corp.
2260 Glenview Dr, Lansdale PA 19446
Phone: (716) 465-5551
Email: kj.eng.consulting.services@gmail.com |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Jeena Mathai
Eerkie Corporation
4027 Runnymeade Dr, Collegeville, PA 19426
Phone: (760) 521-5870
Email: mgsharemg@gmail.com |
| Date Prepared: | August 23, 2023 |
| Device Name: | Rexious Spinal Fixation System
Statera™ Spinal Fixation System
Statera-M™ Spinal Fixation System |
| Common Name: | Pedicle Screw Spinal Fixation System |
| Classification
Name: | Thoracolumbosacral Pedicle Screw System
Spinal Intervertebral Body Fixation Orthosis
Spinal Interlaminal Fixation Orthosis |
| Classification
Number: | 21 CFR 888.3070
21 CFR 888.3060
21 CFR 888.3050 |
| Product Code/
Classification: | NKB, KWP, KWQ, class II |
| Device
Description: | The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-
M™ Spinal System are top-loading multiple component, posterior spinal
fixation systems which consist of pedicle screws, rods, set screws,
connectors, hooks, washers, staples, and transverse (cross) linking
mechanisms. |
| | The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-
M™ Spinal System will allow surgeons to build a spinal implant construct
to stabilize and promote spinal fusion. The implant components are
supplied non-sterile, single use and fabricated from titanium or titanium
alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and from
Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537.
Various sizes of these implants are available. |
| Indications for
Use: | The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-
M™ Spinal System are intended to provide immobilization and stabilization
of spinal segments in skeletally mature patients as an adjunct to fusion in |
4
the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used for posterior non-cervical screw fixation in pediatric patients, the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are indicated as an adjunct to fusion to treat: adolescent idiopathic scoliosis, progressive spinal deformities (i.e., scoliosis, kyphosis, lordosis) including infantile and juvenile idiopathic scoliosis, or neuromuscular scoliosis, and congenital scoliosis, spondylolisthesis, spondylolysis, pseudarthrosis, failed prior fusion, and fracture caused by tumor and/or trauma in pediatric patients.
Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
When used as an anterolateral thoracolumbar system, the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are intended for anterolateral screw (with staples) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
- Performance Data: Non-clinical testing was performed to demonstrate that the subject Statera™ Spinal System, and Statera-M™ Spinal System are substantially equivalent to the predicate device. The following testing was performed in accordance with the ASTM F1717:
- Static compression bending
- Dynamic compression bending
- Static Torsion
The nonclinical tests demonstrate that the Statera™ Spinal System, and Statera-M™ Spinal System are substantially equivalent to the legally marketed predicate devices.
For the remaining subject devices, submission is only transferring name of a system that has already been cleared under K222415. As those subject devices are identical to the predicate devices, no performance testing is required.
Predicate Device: Primary predicate: Dio Medical - Rexious Spinal Fixation System (K222415) Additional predicates: Globus Medical - Revere Stabilization System (K133350)
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- Substantial The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are substantially equivalent to the predicate device, Equivalence: the Dio Medical - Rexious Spinal Fixation System. The Subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. There are no technological differences between the Subject device and its predicate devices. Thus, the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are substantially equivalent to the predicates.
- The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-Conclusion: M™ Spinal System have the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. Thus, the subject devices are substantially equivalent to the predicate devices.