(117 days)
K071824, K0010044
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various instabilities or deformities, which is a therapeutic purpose.
No
The device is described as an implantable system (screws, rods, plugs) used for immobilization and stabilization of spinal segments, which is a therapeutic function rather than a diagnostic one. Its intended use is to treat existing conditions or deformities, not to identify or diagnose them.
No
The device description explicitly states it is comprised of physical components like screws, plugs, rods, and connectors made of titanium alloy, indicating it is a hardware medical device.
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 "immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion." This describes a surgical implant used to treat structural issues in the spine.
- Device Description: The description details components like screws, rods, and connectors, which are typical of spinal fixation systems.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is an in vivo (within the body) implant.
N/A
Intended Use / Indications for Use
The Spine 360 Talon Spinal Fixation System is 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 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 (pseudoarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH
Device Description
The Talon Spinal Fixation System was cleared for use via K071824, and is comprised of polyaxial screws, locking plugs, spinal rods and rod to rod connectors. The Talon System can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Spine 360 proposes to add new smaller diameter (4.5mm) screws in various lengths, cannulated screws in various diameters and lengths, pedicle screw spacers as well as the minimally invasive surgical technique for use with the Spine 360 Talon Spinal System. The new components are based upon the same fundamental scientific technology and do not alter the indications for use as compared to the existing system.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were conducted:
- . Static Compression Bending and Torsion ASTM F1717-09
- Dynamic Compression Bending ASTM F1717-09
The Spine 360 Spinal Fixation System proposed additional 4.5 screws, cannulated screws and spacers demonstrated equivalence or better in compression bending performance and stiffness to the predicate device listed. The dynamic compression bending fatigue strength for the Spine 360 Spinal Fixation System had already demonstrated a greater endurance strength than predicates referenced.
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.
K071824, K0010044
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.
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
KIO2995
Image /page/0/Picture/1 description: The image shows a logo with the word "SPINE" in bold, sans-serif font. To the right of the word "SPINE" are the numbers "360" in a stylized font. The numbers are made up of concentric circles, giving them a three-dimensional appearance. The logo appears to be for a product or service related to spinal health or a 360-degree view of the spine.
FEB - 2 2011
510(k) SUMMARY
Spine 360 Talon Spinal System
Premarket Notification
SUBMITTED BY Spine 360 CONTACT PERSON 5000 Plaza on the Lake, Suite 305 Dave Lamb Austin, Texas 78746 Quality and Regulatory Affairs Phone: 512-364-6400 ext 5 Fax: 800-640-6045
ESTABLISHMENT REGISTRATION NUMBER 3005841736
DATE PREPARED October 1, 2010 COMMON NAME Spinal Fixation System PROPRIETARY NAME Talon Spinal Fixation System CLASSIFICATION NAME and product code CLASS II, MNI 888.3070 - Pedicle Screw Spinal System CLASS II, MNH 888.3070 - Pedicle Screw Spinal System PREDICATE DEVICE Talon Spinal Fixation System(K071824)
Acme System (K0010044)
The Spine 360 Talon Spinal Fixation System(K102995) is substantially equivalent to the above devices.
DEVICE DESCRIPTION
The Talon Spinal Fixation System was cleared for use via K071824, and is comprised of polyaxial screws, locking plugs, spinal rods and rod to rod connectors. The Talon System can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Spine 360 proposes to add new smaller diameter (4.5mm) screws in various lengths, cannulated screws in various diameters and lengths, pedicle screw spacers as well as the minimally invasive surgical technique for use with the Spine 360 Talon Spinal System. The new components are based upon the same fundamental scientific technology and do not alter the indications for use as compared to the existing system.
NONCLINICAL TEST SUMMARY
The following tests were conducted:
- . Static Compression Bending and Torsion ASTM F1717-09
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Image /page/1/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letters 'K1', followed by the numbers '02995'. The handwriting style appears casual, with some variation in the size and spacing of the characters.
Dynamic Compression Bending ASTM F1717-09 �
INTENDED USE
The intended use for the device is the same as the referenced system cleared K071824. The Spine 360 Talon Spinal Fixation System is 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 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 (pseudoarthrosis).
SUBSTANTIAL EQUIVALENCE
The Spine 360 Spinal Fixation System proposed additional 4.5 screws, cannulated screws and spacers demonstrated equivalence or better in compression bending performance and stiffness to the predicate device listed. The dynamic compression bending fatigue strength for the Spine 360 Spinal Fixation System had already demonstrated a greater endurance strength than predicates referenced.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Spine 360 Spinal Fixation System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.
CONCLUSIONS
The Spine 360 Spinal Fixation System including the smaller 4.5 screws, cannulated screws and spacers will provide stability greater than the tolerated thresholds in range of motion and stiffness limits of the human lumbar spine and will adequately stabilize a fusion site.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spine 360 % Mr. Dave Lamb Quality and Regulatory Affairs 5000 Plaza on the Lake, Suite 305 Austin, Texas 78746
FEB -- 2 201
Re: K102995
Trade/Device Name: Talon Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system * Regulatory Class: Class II Product Code: MNI, MNH Dated: December 16, 2010 Received: January 11, 2011
Dear Mr. Lamb:
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
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Page 2 - Mr. Dave Lamb
(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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
A. B. R. d.
for
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Spine 360 Talon Spinal System
Indications for Use:
The Spine 360 Talon Spinal System is 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 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 (pseudoarthrosis).
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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