(96 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system with no mention of software, image processing, AI, or ML. The performance studies are mechanical tests.
No.
The device is a pedicle screw system used for mechanical stabilization of the spine, not a therapeutic agent or device that directly treats disease or injury. It supports fusion, which is a surgical procedure.
No
This device is a spinal fixation system, which is a surgical implant designed to provide immobilization and stabilization of spinal segments, not to diagnose medical conditions.
No
The device description explicitly states it is composed of pedicle screws and rods, which are hardware components, and describes mechanical testing of these components.
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 PressON Pro Spinal Fixation System is a surgical implant used to provide immobilization and stabilization of spinal segments in the body as an adjunct to fusion.
- Device Description: The device is described as composed of pedicle screws and rods, which are physical implants.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
This device is a surgical implant used in vivo (within the living body), not a test performed in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The PressON Pro Spinal Fixation System is a posterical pedicle screw system 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 ve disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI
Device Description
The PressON Pro Spinal Fixation System is composed of pedicle screws and rods. These components can be assembled and implanted using associated instruments via a posterior approach into the pedicles of the noncervical vertebral bodies. Components are made from Ti-6A1-4V ELI (ASTM F-136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine; noncervical vertebral bodies
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)
Verification activities were performed, including mechanical testing as follows: axial load, A/P load, axial torsion, and flexion/extension load per ASTM F1798-13; and static torsion, static compression bending, and dynamic compression bending per ASTM F1717-14.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles a stylized human face or profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 28, 2016
Nexus Spine, LLC Jared Crocker President 2825 East Cottonwood Parkway, Suite 330 Salt Lake City, Utah 84121
Re: K160820
Trade/Device Name: PressON Pro Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: June 3, 2016 Received: June 7, 2016
Dear Mr. Crocker:
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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
PressON Pro Spinal Fixation System
Indications for Use (Describe)
The PressON Pro Spinal Fixation System is a posterical pedicle screw system 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 ve disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/0 description: The image shows the logo for Nexus Spine. The word "NEXUS" is written in a sans-serif font, with the "X" formed by two intersecting lines. The letters "NE" are in gray, while the "US" are in a light blue color. Below the word "NEXUS", the word "SPINE" is written in a smaller, sans-serif font, with each letter separated by a space.
510(k) Summary
| Submitter: | Nexus Spine LLC |
|---|---|
| Contact Person: | Mr. Jared Crocker, President |
| 2825 East Cottonwood Parkway Suite 330 | |
| Salt Lake City, UT 84121 | |
| Telephone: (801) 702-8592 | |
| Fax: (801) 702-8585 | |
| Date Prepared: | March 15, 2016 |
| Trade Name: | PressON Pro Spinal Fixation System |
| Classification, Name | |
| and Number: | Class III |
| Pedicle Screw Spinal System | |
| 21 CFR 888.3070 | |
| Product Code: | MNI, MNH and NKB |
| Predicate Device(s): | The subject device is substantially equivalent to the following devices: |
| PressON Pedicle Screw System (Primary Predicate) | |
| Marketed and distributed by Nexus Spine, LLC | |
| 510(K) Number: K133287 | |
| Expedium MOSS Miami Spinal System | |
| Marketed and distributed by Johnson & Johnson | |
| 510(K) Number K103490 | |
| Alpine Pedicle Screw System | |
| Marketed and distributed by Sanacor LLC | |
| 510(K) Number K090477 | |
| Device Description: | The PressON Pro Spinal Fixation System is composed of pedicle screws |
| and rods. These components can be assembled and implanted using | |
| associated instruments via a posterior approach into the pedicles of the | |
| noncervical vertebral bodies. Components are made from Ti-6A1-4V ELI | |
| (ASTM F-136). | |
| Intended Use: | The PressON Pro Spinal Fixation System is a posterior, non-cervical |
| pedicle screw system 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: degenerative disc disease (defined | |
| as back pain of discogenic origin with degeneration of the disc confirmed | |
| by history and radiographic studies), spondylolisthesis, fracture, dislocation | |
| scoliosis, kyphosis, lordosis, spinal tumor, and failed previous fusion | |
| (pseudarthrosis). | |
| Statement of | |
| Technological | |
| Comparison: | The PressON Pro Spinal Fixation System is substantially equivalent to |
| the above listed predicate devices in terms of materials, design, | |
| indications for use and operational principles. | |
| Performance Data: | Verification activities were performed, including mechanical testing as |
| follows: axial load, A/P load, axial torsion, and flexion/extension load per | |
| ASTM F1798-13; and static torsion, static compression bending, and | |
| dynamic compression bending per ASTM F1717-14. | |
| Conclusion: | Documentation provided demonstrates the PressON Pro Spinal Fixation |
| System is substantially equivalent to predicate devices. |
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Image /page/5/Picture/0 description: The image shows the logo for Nexus Spine. The word "NEXUS" is in gray and blue, with the "X" being a stylized design. Below the word "NEXUS" is the word "SPINE" in gray.