(59 days)
No
The device description and performance studies focus solely on the mechanical properties and intended use of spinal implants (screws, rods, hooks, cross links, bolts, and rings). There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is described as providing "immobilization of the spine" and "sacroiliac joint fusion," which are therapeutic interventions aimed at treating medical conditions.
No
The device is described as a spinal fixation system, intended to provide immobilization and stabilization of the spine as an adjunct to fusion, which is a therapeutic rather than diagnostic function.
No
The device description explicitly details physical components made of titanium and cobalt-chrome alloys, such as screws, rods, hooks, and cross links, 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 fusion of the spine and sacroiliac joint. This is a therapeutic and structural function within the body.
- Device Description: The description details physical components like screws, rods, hooks, and cross links made from materials like titanium and cobalt-chrome. These are physical implants, not reagents or instruments used to test biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
- Performance Studies: The performance studies described are mechanical testing of the implants, not clinical or analytical performance studies typical for IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support and fusion within the body.
N/A
Intended Use / Indications for Use
The Pantheon Pedicle Screw System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). This system is intended for anterior/anteral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (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), tumor, pseudoarthrosis, and failed previous fusion.
The Pantheon Iliac Bolt Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes
NKB, KWP, KWQ, OUR
Device Description
The Pantheon Pedicle Screw Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, hooks, and cross links that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). Implant components are available in a variety of sizes so that constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with screws.
The Pantheon Iliac Bolt Fixation System has threaded screw implants with dual helix threads designed to be able to screw into pre-drilled bone in the sacrum. Implant components are available in a variety of sizes so that constructs may be assembled to suit the individual pathology and anatomy of the patient. Optional lag rings are also available.
Screws, rods, cross links, and other implant components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. Additionally, some rods may be manufactured from cobalt-chrome alloy (Co-Cr) conforming to ASTM F1537 or ISO 5832-12.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (the thoracic spine through the sacrum and in the ilium)
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)
Mechanical performance testing of the Pantheon Pedicle Screw and Iliac Bolt System was evaluated based on the Guidance for Industry and FDA Staff, Spinal System 510(k)s. The Pedicle Screw System was evaluated per ASTM F1717 and ASTM F1798. The Iliac Bolt Fixation System was evaluated per ASTM F2193 and ASTM F543. No clinical testing is being submitted with the 510(k). The results and analysis of the Pantheon Pedicle Screw and Iliac Bolt Fixation performance testing demonstrate that the subject and predicate devices are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Talon Spinal System (K102995)
Reference Device(s)
Outlet Sacroiliac Joint Fusion System (K181881)
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
July 26, 2024
Image /page/0/Picture/1 description: The image contains 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. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Pantheon Spinal % Daniel Johnson Regulatory Engineer DJJ Consulting LLC 425 Literary Rd Suite 401 Cleveland, Ohio 44113
Re: K241494
Trade/Device Name: Pantheon Pedicle Screw and Iliac Bolt Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ, OUR Dated: May 24, 2024 Received: May 28, 2024
Dear Daniel Johnson:
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
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2024.07.26
15:15:28 -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) K241494
Device Name
Pantheon Pedicle Screw and Iliac Bolt Fixation System
Indications for Use (Describe)
The Pantheon Pedicle Screw System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). This system is intended for anterior/anteral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (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), tumor, pseudoarthrosis, and failed previous fusion.
The Pantheon Iliac Bolt Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Pantheon Spinal. The logo consists of an orange circle with a smaller white circle inside, followed by the word "PANTHEON" in black, and the word "SPINAL" in orange below it. The logo is simple and modern, and the use of orange and black gives it a professional look.
Pedicle Screw & Iliac Bolt Fixation System 510(k) Summary
| Submitted By: | Pantheon Spinal
40132 Industrial Park Cir. Suite #101
Georgetown, TX 78626 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 07/26/2024 |
| Contact Person: | Daniel Johnson, Regulatory Consultant |
| Contact Telephone: | (216) 333-2127 |
| Device Trade Name: | Pedicle Screw and Iliac Bolt Fixation System |
| Common Name: | Pedicle Screw Spinal System |
| Classification Name: | Thoracolumbosacral Pedicle Screw System, Spinal Interlamina
Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis,
Smooth or Threaded Metallic Bone Fixation Fastener |
| Regulation Number: | 21 CFR Section 888.3070, 888.3050, 888.3060, 888.3040 |
| Reviewing Panel: | Orthopedic |
| Product Codes: | NKB, KWP, KWQ, OUR |
| Primary Predicate: | Talon Spinal System (K102995) |
| Reference Predicate: | Outlet Sacroiliac Joint Fusion System (K181881) |
Device Description:
The Pantheon Pedicle Screw Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, hooks, and cross links that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). Implant components are available in a variety of sizes so that constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with screws.
The Pantheon Iliac Bolt Fixation System has threaded screw implants with dual helix threads designed to be able to screw into pre-drilled bone in the sacrum. Implant components are available in a variety of sizes so that constructs may be assembled to suit the individual pathology and anatomy of the patient. Optional lag rings are also available.
Screws, rods, cross links, and other implant components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. Additionally, some rods may be manufactured from cobalt-chrome alloy (Co-Cr) conforming to ASTM F1537 or ISO 5832-12.
Indications for Use:
The Pantheon Pedicle Screw System is intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adiunct to fusion for procedures of the thoracic. lumbar, and sacral spine (T1-S1). This system is intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications:
4
Image /page/4/Picture/0 description: The image is a logo for Pantheon Spinal. The logo consists of an orange circular graphic on the left, followed by the word "PANTHEON" in black, and the word "SPINAL" in orange below it. The circular graphic appears to be a stylized representation of a spinal disc.
Pedicle Screw & Iliac Bolt Fixation System 510(k) Summary
degenerative disc disease (DDD) (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, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Pantheon Iliac Bolt Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Summary Statements:
The subject device indications are the same as the predicate device indications.
The subject and predicate devices have the same technological characteristics.
Mechanical performance testing of the Pantheon Pedicle Screw and Iliac Bolt System was evaluated based on the Guidance for Industry and FDA Staff, Spinal System 510(k)s. The Pedicle Screw System was evaluated per ASTM F1717 and ASTM F1798. The Iliac Bolt Fixation System was evaluated per ASTM F2193 and ASTM F543. No clinical testing is being submitted with the 510(k). The results and analysis of the Pantheon Pedicle Screw and Iliac Bolt Fixation performance testing demonstrate that the subject and predicate devices are substantially equivalent.
Conclusion: The subject device is substantially equivalent to the predicate devices.