(106 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical implantation techniques of a pedicle screw system, with no mention of AI or ML.
No.
The device is a pedicle screw system intended for immobilization and stabilization of spinal segments as an adjunct to fusion, rather than directly providing a therapeutic effect itself.
No
The device is an implantable pedicle screw system used for stabilization of spinal segments, not for diagnosis. Fluoroscopy is mentioned as an imaging modality for implantation, not for diagnostic purposes.
No
The device description explicitly states it is comprised of physical components like screws, lock plugs, cross-links, tulips, and rods, which are hardware.
Based on the provided information, this device 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 safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The TiLock Pedicle Screw System is a surgical implant intended to provide immobilization and stabilization of spinal segments within the patient's body. It is used as an adjunct to fusion in the treatment of various spinal conditions.
- No Specimen Examination: The description does not mention the examination of any biological specimens (blood, tissue, etc.) outside of the body.
- Direct Patient Intervention: The device is directly implanted into the patient's spine.
Therefore, the TiLock Pedicle Screw System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The TiLock Pedicle Screw 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: degenerative disc disease (DDD) (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 failed previous fusion.
Product codes
NKB, MNI, MNH
Device Description
The Genesys Spine TiLock Pedicle Screw System is comprised of polyaxial screws (standard and cannulated) and monoaxial screws in various lengths and diameters, lock plugs, cross-links, tulips and rods in various lengths. The Til ock System only allows the placement of 5.5 mm titanium rods. The TiLock cannulated polyaxial screws may be implanted via a minimally invasive technique. Manual instrumentation for implantation of the system is available for both conventional and minimally invasive procedures. The minimally invasive procedure is performed using k-wire and fluoroscopy, which allows the implanting surgeon to employ two smaller incisions rather than a longer midline incision.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
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 non-clinical tests were conducted, the results of which demonstrate that the Genesys Spine Tillock Pedicle Screw System is substantially equivalent to the predicate(s):
- -Static and dynamic axial compression bending testing, conducted in accordance with ASTM F1717-04
- Static torsion testing, conducted in accordance with ASTM F1717-04 -
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K984578, K081252, K041801, K955348, K984350, K983904
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
JUL -1 2010
Genesys Spine Genesys Spine TiLock Pedicle Screw System
510(k) Summary of Safety and Effectiveness
SUBMITTED BY
Genesys Spine 1250 Capital of Texas Highway South Building Three, Suite 600 Austin, Texas 78746
ESTABLISHMENT REGISTRATION NUMBER
Pending
CONTACT PERSON
Primarv Josh Kaufmann Principal Genesys Spine Phone: 512-560-3446 Fax: 800-817-4938
SUBMISSION PREPARED BY Lisa Peterson
QA Consulting, Inc. Phone: 512-507-0746 Fax: 512-857-1278
DATE PREPARED
March 15, 2010
CLASSIFICATION NAME
NKB 888.3070 - Pedicle Screw Spinal System MNI 888.3070 - Pedicle Screw Spinal System MNH 888.3070 - Pedicle Screw Spinal System
COMMON NAME Spinal Fixation System
PROPRIETARY NAME TiLock Pedicle Screw System
DEVICE DESCRIPTION
The Genesys Spine TiLock Pedicle Screw System is comprised of polyaxial screws (standard and cannulated) and monoaxial screws in various lengths and diameters, lock plugs, cross-links, tulips and rods in various lengths. The Til ock System only allows the placement of 5.5 mm titanium rods.
1
The TiLock cannulated polyaxial screws may be implanted via a minimally invasive technique. Manual instrumentation for implantation of the system is available for both conventional and minimally invasive procedures. The minimally invasive procedure is performed using k-wire and fluoroscopy, which allows the implanting surgeon to employ two smaller incisions rather than a longer midline incision.
INDICATIONS:
The TiLock Pedicle Screw 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: degenerative disc disease (DDD) (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 failed previous fusion.
SUBSTANTIAL EQUIVALENCE AND TECHNOLOGICAL CHARACTERISTICS
The Genesys Spine TiLock System was determined to be substantially equivalent to the following predicate systems:
Interpore Cross Synergy Polyaxial (K984578) DePuy Spine Expedium (K081252, K041801) DePuy Spine Moss Miami (K955348) DePuv Spine VSP Spine System (K984350) US Surgical Rogozinski Spinal Rod System (K983904)
The subject and predicate device share the same intended use and material of manufacture. The subject and predicate device have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Mechanical test results demonstrate that the minor differences do not impact device performance as compared to the predicate.
DISCUSSION OF NON-CLINICAL AND CLINICAL DATA
The following non-clinical tests were conducted, the results of which demonstrate that the Genesys Spine Tillock Pedicle Screw System is substantially equivalent to the predicate(s):
- -Static and dynamic axial compression bending testing, conducted in accordance with ASTM F1717-04
- Static torsion testing, conducted in accordance with ASTM F1717-04 -
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by a serpent and topped with wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Genesys Spine % Mr. Josh Kaufmann 1250 Capital of Texas Highway South Building Three, Suite 600 Austin, Texas 78746
BUL-1 2010
Re: K100757
Trade/Device Name: TiLock Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: June 17, 2010 Received: June 18, 2010
Dear Mr. Kaufmann:
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 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.
3
Page 2 - Mr. Josh Kaufmann
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/CDRH/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, 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:
Genesys Spine TiLock Pedicle Screw System
Indications for Use:
The TiLock Pedicle Screw 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: degenerative disc disease (DDD) (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 failed previous fusion.
Prescription Use _ x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Qria Hia
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100757
1250 Canital of Texas Highway South Building Three, Suite 600 Austin. Texas 78746
Genesys Spine
Phone: 512-560-3446
Fax: 800-817-4938
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