(30 days)
Not Found
No
The 510(k) summary describes a mechanical pedicular fixation system and does not mention any AI or ML components or capabilities.
Yes.
The device is intended for posterior, non-cervical fixation as an adjunct to fusion for a variety of medical conditions affecting the spine, such as degenerative disc disease, spondylolisthesis, trauma, and spinal stenosis. Its purpose is to provide immobilization and stabilization of spinal segments, which are therapeutic actions.
No.
The device is a pedicular fixation system intended for posterior, non-cervical fixation to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It is a surgical implant, not a diagnostic tool.
No
The device description explicitly states the system consists of physical components like screws and rods made of titanium and cobalt chrome, which are hardware.
Based on the provided information, the Spineology Fortress™ Pedicular Fixation System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Spineology Fortress™ Pedicular Fixation System is described as a system of screws and rods intended for surgical implantation to stabilize the spine. This is a medical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Intended Use: The intended use clearly states it's for posterior, non-cervical fixation as an adjunct to fusion for various spinal conditions. This involves surgical intervention and implantation, not diagnostic testing of bodily samples.
Therefore, the Spineology Fortress™ Pedicular Fixation System falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spineology Fortress™ Pedicular Fixation System is intended for posterior, non-cervical fixation 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 and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI
Device Description
The Spineology Fortress™ Pedicular Fixation System consists of screws (titanium) and rods (cobalt chrome) to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Fortress System screws are available with or without hydroxyapatite coating. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile. The associated instruments are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical fixation; thoracic, lumbar, and sacral spine.
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)
Coating characterization/analyses were provided. The results of a risk analysis support a determination that the device is substantially equivalent to the identified predicate devices.
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.
Spineology Fortress Pedicle Screw System [K140010], Globus Beacon® Stabilization System [K121922]
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2015
Spineology, Incorporated Ms. Karen Roche Vice President, Operations & Technology 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128
Re: K152148
Trade/Device Name: Fortress™ Pedicular Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: July 31, 2015 Received: August 3, 2015
Dear Ms. Roche:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Karen Roche
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/Resourcesfor You/Industry/default.htm. 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
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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152148
Device Name Fortress™ Pedicular Fixation System
Indications for Use (Describe)
The Spineology Fortress™ Pedicular Fixation System is intended for posterior, non-cervical fixation 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 and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
| 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
2. 510(k) Summary
| Applicant: | Spineology Inc.
7800 3rd Street N., Suite 600
Saint Paul, MN 55128
Phone: 651-256-8500
Fax: 651-256-8505 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Roche |
| Date Prepared: | July 31, 2015 |
| Trade Name: | Fortress™ Pedicular Fixation System |
| Product
Classification
and Code: | Pedicle Screw Spinal System
Class III per 21 CFR 888.3070, Product Codes NKB, MNI, MNH |
| Predicate
Device(s): | Primary: Spineology Fortress Pedicle Screw System [K140010]
Additional: Globus Beacon® Stabilization System [K121922] |
| Device
Description: | The Spineology Fortress™ Pedicular Fixation System consists of screws
(titanium) and rods (cobalt chrome) to allow the surgeon to build an implant
system to fit the patient's anatomical and physiological requirements. The
Fortress System screws are available with or without hydroxyapatite
coating. The system is intended to provide immobilization and stabilization
of spinal segments in skeletally mature patients as an adjunct to fusion in
the treatment of acute and chronic instabilities or deformities of the thoracic,
lumbar, and sacral spine. The devices are provided sterile. The associated
instruments are provided non-sterile. |
| Intended Use: | The Spineology Fortress™ Pedicular Fixation System is intended for
posterior, non-cervical fixation 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 and/or lordosis); tumor;
pseudoarthrosis; and/or failed previous fusion. |
| Purpose of this
510(k): | The purpose of this submission is to request clearance for adding
hydroxyapatite (HA)-coated screws to the Fortress™ System. |
| Summary of
Technological
Characteristics: | The subject screws have a hydroxyapatite coating on the screw threads.
The base material, thread form, and screw sizes are the same as the
predicate devices. The technological characteristics remain the same as the
predicate devices with respect to intended use, indications for use, design,
fundamental technology, and operational principles. |
| Testing | Coating characterization/analyses were provided. The results of a risk
analysis support a determination that the device is substantially equivalent to
the identified predicate devices. |
| Conclusion: | The information submitted in this premarket notification supports a
determination that the Fortress™ Pedicular Fixation System is substantially
equivalent in technological characteristics and intended use to the predicate
devices. |