(111 days)
No
The summary describes a mechanical implant system for spinal fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a system for posterior, non-cervical fixation as an adjunct to fusion for multiple medical conditions, clearly indicating a therapeutic purpose.
No
The device description clearly states its purpose as an implant system for immobilization and stabilization of spinal segments, acting as an adjunct to fusion. It does not mention any diagnostic capabilities.
No
The device description explicitly states it consists of screws (titanium) and rods (cobalt chrome), which are hardware components. It also mentions associated instruments.
Based on the provided information, the Spineology Fortress™ Pedicle Screw System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of transfused blood, or to monitor therapeutic measures.
- Device Description and Intended Use: The Spineology Fortress™ Pedicle Screw System is a surgical implant system consisting of screws and rods. Its intended use is for posterior, non-cervical fixation as an adjunct to fusion in the spine. This involves physically implanting the device into the patient's body to provide structural support and stabilization.
- Lack of Specimen Examination: The description does not mention the device being used to examine any biological specimens (blood, tissue, etc.) outside of the body.
- Direct Patient Intervention: The device is directly implanted into the patient during surgery, which is a therapeutic intervention, not a diagnostic test performed on a specimen.
Therefore, the Spineology Fortress™ Pedicle Screw System falls under the category of a surgical implant or spinal fixation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Spineology Fortress™ Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients 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.
Product codes
MNI, MNH, NKB
Device Description
The Spineology Fortress™ Pedicle Screw 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 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 or non-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
non-cervical spine (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
Mechanical testing was performed as follows: flexural grip, torsional grip, and axial grip tests according to F1798-97(2008), axial pullout and torque to failure per ASTM F543-13, static torsion and static and dynamic compression bending according to ASTM F1717-13.
Key Metrics
Not Found
Predicate Device(s)
KBB EOS Pedicle Screw System (K082509), CD Horizon Spinal Fixation System from Medtronic Sofamor Danek (K132471)
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
APR 2 3 2014
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: | April 21, 2014 |
| Trade Name: | Spineology Fortress™ Pedicle Screw System |
| Product Classification
and Code: | Class III per 21 CFR 888.3070. Product Codes MNI. MNH, and NKB |
| Predicate Device(s): | KBB EOS Pedicle Screw System (K082509) and CD Horizon Spinal
Fixation System from Medtronic Sofamor Danek (most recent clearance is
K132471) |
| Device Description: | The Spineology Fortress™ Pedicle Screw 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 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 or non-sterile. The associated instruments are provided non-
sterile. |
| Intended Use: | The Spineology Fortress™ Pedicle Screw System is intended for posterior, non-
cervical fixation as an adjunct to fusion in skeletally mature patients 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): | New product. |
| Summary of
Technological
Characteristics: | The device is shown to be substantially equivalent to the intended use, materials,
configuration, and performance characteristics of the predicate products. |
| Testing | Mechanical testing was performed as follows: flexural grip, torsional grip, and
axial grip tests according to F1798-97(2008), axial pullout and torque to failure
per ASTM F543-13, static torsion and static and dynamic compression bending
according to ASTM F1717-13. |
| Conclusion: | The information submitted in this premarket notification supports a
determination that the devices subject to this submission are substantially
equivalent in technological characteristics and intended use to the predicate
devices. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2014
Spineology Incorporated Ms. Karen Roche Vice President, Operations & Technology 7800 Third Street North. Suite 600 Saint Paul, Minnesota 55128
Re: K140010
Trade/Device Name: Fortress™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: March 25, 2014 Received: March 26, 2014
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
2
Page 2 - Ms. Karen Roche
forth in the quality systems (QS) regulation (2) 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" (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 yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510{k} Number (if known) K140010
Device Name
Fortress Pedicle Screw system
Indications for Use (Describe)
The Spineology Fortress™ Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative discase (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)
2 Proscription 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)
James P. Bertram -S 2014.04.23 08:47:44 -04'00'
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