(77 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a spinal fixation system, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Pedicular Fixation System" intended for "posterior, non-cervical fixation as an adjunct to fusion" for various spinal conditions, indicating its use in treating medical conditions to improve health.
No
This device is a surgical implant system intended for immobilization and stabilization of spinal segments, acting as an adjunct to fusion. It does not perform any diagnostic function.
No
The device description explicitly states it consists of physical components made of titanium alloy (screws, rods, connectors) and is intended for surgical implantation. This is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a surgical implant system (screws, rods, connectors) intended for posterior spinal fixation as an adjunct to fusion. This is a device used within the body during surgery, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to sample collection, analysis, or diagnostic testing.
Therefore, the Spineology Threshold™ V2 Pedicular Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Spineology Threshold™ V2 Pedicular Fixation 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
NKB
Device Description
The Spineology Threshold Pedicular Fixation System consists of solid standard and reduction screws (titanium alloy), curved and straight rods (titanium alloy), and adjustable ConneX Cross Connector and fixed Connex Rod Connector (titanium alloy) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Threshold solid standard and reductions screws are available with or without a 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 solid standard and reduction screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.
Spineology Connex Cross Connector devices are transversely-placed implants that are intended to connect the rod on one side of the spinal construct to the rod on the other side. These devices are manufactured from titanium alloy and are adjustable to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. ConneX Cross Connector devices are intended to be used with Spineology's Fortress™, Threshold V2™, and Palisade™ Pedicular Fixation Systems which are 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.
Spineology Connex Rod Connector devices are implants that are intended to connect two rods in a spinal construct. These devices are manufactured from titanium alloy and the components allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Connex Rod Connector devices are intended to be used with Spineology's Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems which are 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Non-Clinical Testing:
Bacterial endotoxin testing (BET) for all Threshold V2 devices was conducted in accordance with ANSI/AAMI ST-72:2011.
No new mechanical testing was required for Pedicle Screws, Pre-Bent Rods, and Set Screws, as they were previously cleared and not modified.
No new mechanical testing was required for Reduction Screws, as they are identical to previously cleared pedicle screws with the exception of integrated removable extension towers.
Mechanical testing was conducted on representative Straight Rod devices in accordance with FDA Guidance: Spinal System 510(k)s (2004) and applicable American Society for Testing and Materials (ASTM) standards, specifically ASTM F1717-15 for Static Compression Bending.
Mechanical testing was conducted on representative worst case ConneX Cross Connector and Connex Rod Connector devices in accordance with FDA Guidance: Spinal System 510(k)s (2004) and applicable American Society for Testing and Materials (ASTM) standards: ASTM F1717 (Static Compression Bending), ASTM F1798 (Flexural Grip), and ASTM F2193 (Static Cantilever Bending, Dynamic Compression Bending).
Key Metrics
Not Found
Predicate Device(s)
K161694, K143403, K160980, K123352, K152968, K120838
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.
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Image /page/0/Picture/2 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 circle is an abstract symbol resembling a stylized caduceus, with three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2017
Spineology Inc. Ms. Jacqueline A. Hauge Regulatory Affairs Manager 7800 3rd Street North. Suite 600 Saint Paul, Minnesota 55128
Re: K170255
Trade/Device Name: Threshold™ V2 Pedicular Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: January 26, 2017 Received: January 27, 2017
Dear Ms. Hauge:
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 of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (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,
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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Indications for Use
510(k) Number (if known) K170255
Device Name Threshold™ V2 Pedicular Fixation System
Indications for Use (Describe)
The Spineology Threshold™ V2 Pedicular Fixation 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.
| 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
Image /page/3/Picture/1 description: The image shows the word "Spineology" in a bold, sans-serif font. To the right of the word is a graphic of a cluster of purple dots, arranged in a circular pattern. The word "Spineology" is likely the name of a company or organization.
| Date Prepared: | April 11, 2017 |
|---|---|
| Submitter: | Spineology Inc. |
| 7800 3rd Street North | |
| Suite 600 | |
| Saint Paul, MN 55128 | |
| Establishment Registration Number: 2135156 | |
| Contact Person: | Jacqueline A. Hauge |
| Regulatory Affairs Manager | |
| Phone: 651.256.8534 | |
| Fax: 651.256.8505 | |
| Email: ihauge@spineology.com |
Device Name and Classification
| Trade Name: | Threshold™ V2 Pedicular Fixation System |
|---|---|
| Common Name: | Thoracolumbosacral Pedicle Screw System |
| Classification Name: | Orthosis, Spinal Pedicle Fixation |
| Product Codes: | NKB |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 888.3070 |
| Panel: | Orthopedic |
Predicate Devices
| Primary: | K161694 | Threshold™ Pedicular Fixation Systems (Spineology Inc.) |
|---|---|---|
| Additional: | K143403 | Threshold™ Pedicular Fixation System (Spineology Inc.) |
| K160980 | Threshold™ and Palisade™ Pedicular Fixation Systems (Spineology Inc.) | |
| K123352 | S4™ Spinal System (Aesculap Implant Systems, Inc.) | |
| K152968 | Arsenal™ Spinal Fixation System (Alphatec Spine, Inc.) | |
| K120838 | Synthes Matrix™ System (Synthes Spine) |
I. Purpose
The purpose of this submission is to obtain FDA clearance of Spineology's Threshold™ V2 Pedicular Fixation System.
II. Regulatory History
No prior submissions have been provided to FDA for the Threshold V2 Pedicular Fixation System.
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III. Device Description
Threshold™ V2 System A.
The Spineology Threshold Pedicular Fixation System consists of solid standard and reduction screws (titanium alloy), curved and straight rods (titanium alloy), and adjustable ConneX Cross Connector and fixed Connex Rod Connector (titanium alloy) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Threshold solid standard and reductions screws are available with or without a 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 solid standard and reduction screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.
B. ConneX™ Cross Connectors
Spineology Connex Cross Connector devices are transversely-placed implants that are intended to connect the rod on one side of the spinal construct to the rod on the other side. These devices are manufactured from titanium alloy and are adjustable to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. ConneX Cross Connector devices are intended to be used with Spineology's Fortress™, Threshold V2™, and Palisade™ Pedicular Fixation Systems which are 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.
C. ConneX™ Rod Connectors
Spineology Connex Rod Connector devices are implants that are intended to connect two rods in a spinal construct. These devices are manufactured from titanium alloy and the components allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Connex Rod Connector devices are intended to be used with Spineology's Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems which are 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.
IV. Indications for Use
The Spineology Threshold™ V2 Pedicular Fixation 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, and/or lordosis); tumor; pseudoarthrosis: and/or failed previous fusion.
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V. Comparison to Predicate
When compared to the predicate devices, the Threshold V2 Pedicular Fixation System has the same:
- Intended Use ●
- . Indications for Use
- . Fundamental Scientific Technology
VI. Non-Clinical Testing
Bacterial endotoxin testing (BET) for all Threshold V2 devices was conducted in accordance with ANSI/AAMI ST-72:2011.
A. Pedicle Screws, Pre-Bent Rods, and Set Screws
New mechanical testing was not required to establish the performance of Threshold V2 pedicle screws, pre-bent rods, and set screws. These devices were previously cleared under a separate 510(k) and have not been modified since their initial clearance.
B. Reduction Screws
New mechanical testing was not required to support the performance of Threshold V2 reduction screws. These screws are identical to previously cleared Threshold V2 pedicle screws with the exception of the integrated removable (non-implanted) extension towers on the tulip of the device.
C. Straight Rods
The following mechanical testing was conducted on representative Straight Rod devices in accordance with FDA Guidance: Spinal System 510(k)s (2004) and applicable American Society for Testing and Materials (ASTM) standards:
ASTM F1717-15
- · Static Compression Bending
D. ConneX™ Cross Connectors and ConneX™ Rod Connectors
The following mechanical testing was conducted on representative worst case ConneX Cross Connector and Connex Rod Connector devices in accordance with FDA Guidance: Spinal System 510(k)s (2004) and applicable American Society for Testing and Materials (ASTM) standards:
ASTM F1717
ASTM F1798 • Flexural Grip
ASTM F2193 · Static Cantilever Bending
- · Static Compression Bending • Dynamic Compression Bending
VII. Conclusion
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Threshold V2 Pedicular Fixation System has been shown to be substantially equivalent to the legally marketed predicate devices.
- Principle of Operation
- . Materials of Construction