(25 days)
Not Found
No
The summary describes a mechanical pedicular fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for posterior, non-cervical fixation as an adjunct to fusion for various indications such as degenerative disc disease and spondylolisthesis, and its purpose is to provide immobilization and stabilization of spinal segments. These functions align with the definition of a therapeutic device which aims to treat or alleviate a medical condition.
No
This device is a surgical fixation system used as an adjunct to fusion for treating spinal instabilities and deformities. It is not designed to diagnose medical conditions, but rather to stabilize them.
No
The device description explicitly states it consists of "cannulated and solid titanium alloy screws and rods," which are physical hardware 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 device is for "posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients." This describes a surgical implant used to stabilize the spine.
- Device Description: The description details "cannulated and solid titanium alloy screws and rods" used to build an implant system. This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
- Performance Studies: The performance studies described are mechanical testing of the implant's properties and bacterial endotoxin testing, which are relevant to the safety and efficacy of a surgical implant, not a diagnostic test.
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 stabilization.
N/A
Intended Use / Indications for Use
The Threshold™ 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); turnor; pseudoarthrosis; and/ or failed previous fusion.
Product codes
NKB, MNI, MNH
Device Description
Spineology's Threshold Pedicular Fixation System consists of cannulated and solid titanium alloy screws and rods to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Threshold cannulated and solid 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 cannulated and solid screws can be placed in the pedicles in a variety of trajectories ranging from 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.
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)
Non-Clinical Testing:
Testing was not required to support the addition of uncoated and HA-coated Threshold solid pedicle screws. Spineology's risk analysis, a finite element analysis (FEA), and previous mechanical testing conducted on the predicate devices is sufficient to demonstrate the substantial equivalence of the uncoated and HA-coated Threshold solid pedicle screws to the predicate devices.
The previous mechanical testing was performed in accordance with:
- ASTM F1798-97 Standard Guide for Evaluating Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- ASTM F543-13 Standard Specification and Test Methods for Metallic Medical bone Screws
- ASTM F1717-13 Standard Specification and Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Bacterial Endotoxin testing (BET), also known as the Limulus amebocyte lysate (LAL) test, was performed per ANSI/AAMI/ST72 to a limit of
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2016
Spineology Incorporated Ms. Jacqueline Hauge Regulatory Affairs Manager 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128-5455
Re: K161694
Trade/Device Name: Threshold" 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: June 17, 2016 Received: June 20, 2016
Dear Ms. Hauge:
This letter corrects our substantially equivalent letter of July 15, 2016.
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-related adverse events) (21 CFR Part 803); good manufacturing practice requirements as
1
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/Resourcesfor You/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,
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) K161694
Device Name Threshold™ Pedicular Fixation System
Indications for Use (Describe)
The Threshold™ 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); turnor; 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
| Date Prepared: | July 8, 2016 |
|---|---|
| ---------------- | -------------- |
Submitter:
Spineology Inc. 7800 3rd Street North Suite 600 Saint Paul, MN 55128 Establishment Registration Number: 2135156
| Contact Person: | Jacqueline A. Hauge |
|---|---|
| Regulatory Affairs Manger | |
| Phone: | 651.256.8534 |
| Fax: | 651.256.8505 |
| Email: | jhauge@spineology.com |
Device Name and Classification
| Trade Name: | Threshold™ Pedicular Fixation System |
|---|---|
| Common Name: | Pedicle Screw System |
| Classification Name: | Orthosis, Spinal Pedicle Fixation |
| Product Codes: | NKB, MNI, MNH |
| Regulatory Class: | NKB: Class III MNI, MNH: Class II |
| Regulation Number: | NKB: 888.3070(b)(2) MNI, MNH: 888.3070(b)(1) |
| Panel: | Orthopedic |
Predicate Devices
| Primary: | K143403 | Threshold™ Pedicular Fixation System |
|---|---|---|
| Additional: | K140010 | Fortress™ Pedicle Screw System |
| K160980 | Threshold™ Pedicular Fixation System | |
| K152148 | Fortress™ Pedicle Screw System |
Purpose
Obtain 510(k) clearance for the addition of uncoated and hydroxyapatite (HA) coated Threshold solid pedicle screws to Spineology's Threshold Pedicular Fixation System.
Device Description
Spineology's Threshold Pedicular Fixation System consists of cannulated and solid titanium alloy screws and rods to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Threshold cannulated and solid 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 cannulated and solid screws can be placed in the pedicles in a variety of trajectories ranging from 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.
4
Indications for Use
The Threshold 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.
Comparison to Predicate
When compared to the predicate devices, uncoated and HA-coated Threshold solid pedicle screws have the same:
- Intended Use
- Indications for Use
- Fundamental Scientific Technology
- Principle of Operation ●
- . Biological Safety
- Biological Safety
- Base Materials
- Size Offering
- Hydroxyapatite (HA) Coating ●
Non-Clinical Testing
Testing was not required to support the addition of uncoated and HA-coated Threshold solid pedicle screws. Spineology's risk analysis, a finite element analysis (FEA), and previous mechanical testing conducted on the predicate devices is sufficient to demonstrate the substantial equivalence of the uncoated and HA-coated Threshold solid pedicle screws to the predicate devices.
The previous mechanical testing was performed in accordance with:
- ASTM F1798-97 Standard Guide for Evaluating Static and Fatigue Properties of ● Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- Standard Specification and Test Methods for Metallic Medical bone ● ASTM F543-13 Screws
- Standard Specification and Test Methods for Spinal Implant Constructs . ASTM F1717-13 in a Vertebrectomy Model
Bacterial Endotoxin testing (BET), also known as the Limulus amebocyte lysate (LAL) test, was performed per ANSI/AAMI/ST72 to a limit of