(107 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is intended to treat various acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine as an adjunct to fusion, which qualifies it as a therapeutic device.
No
The device is a spinal fixation system intended to provide immobilization of spinal segments as an adjunct to fusion; it is not used to diagnose conditions.
No
The device description explicitly states it consists of physical components like screws, lock screws, rods, and instruments made from titanium and cobalt chrome alloys. It is a hardware-based spinal fixation system.
Based on the provided information, the Genesys Spine TiLock Modular Spinal System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for spinal fixation and fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, rods, and instruments used in surgery. It does not mention any reagents, assays, or procedures for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Genesys Spine TiLock Modular Spinal System is a medical device used in the body for structural support and stabilization.
N/A
Intended Use / Indications for Use
The Genesys Spine TiLock Modular Spinal System is intended for the following indications:
The Genesys Spine TiLock Modular Spinal System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and nonpedicle spinal fixation, to provide immobilization 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 racic, lumbar, and sacral spine: degenerative disc disease (DDD); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used for posterior non-cervical screw fixation in pediatric patients, Genesys Spine TiLock Modular Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Genesys Spine TiLock Modular Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
The Genesys Spine TiLock Modular Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Genesys Spine TiLock Modular Spinal System is also intended for the following indications: degenerative disc disease (DDD); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP, KWQ
Device Description
The Genesys Spine TiLock Modular Spinal System is a spinal system that consists of a variety screws, lock screws, rods and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The TiLock Modular Spinal System implants are manufactured from titanium alloy per ASTM F136 and F1472 and Cobalt Chrome per ASTM F1537.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
The over-the-wire procedure is performed using k-wires and fluoroscopy.
Anatomical Site
posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, skeletal segments in the thoracic, lumbar, and sacral spine, L5-S1 vertebral joint, L3 to sacrum
Indicated Patient Age Range
skeletally mature patients, pediatric 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)
Nonclinical testing was performed to demonstrate that the subject Genesys Spine TiLock Modular Spinal System is substantially equivalent to other predicate device. The following testing was performed:
- Static Compression Bending per ASTM F1717
- Dynamic Compression Bending per ASTM F1717
- Static Torsion per ASTM F1717
- Tulip Pull-off per ASTM F1798
The results demonstrate that the subject Genesys Spine TiLock Modular Spinal System is substantially equivalent to the predicate.
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.
K161914, K171838, K100757 / K103671, K142737
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.
Not Found
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
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November 30, 2017
Genesys Spine Mr. Brian J. Bergeron Vice President of Engineering 1250 Capital of Texas Highway South Building 3 Suite 600 Austin, Texas 78746
Re: K172469
Trade/Device Name: TiLock Modular Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: November 15, 2017 Received: November 21, 2017
Dear Mr. Bergeron:
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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@Ida.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172469
Device Name Genesys Spine TiLock Modular Spinal System
Indications for Use (Describe)
The Genesys Spine TiLock Modular Spinal System is intended for the following indications:
The Genesys Spine TiLock Modular Spinal System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and nonpedicle spinal fixation, to provide immobilization 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 racic, lumbar, and sacral spine: degenerative disc disease (DDD); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used for posterior non-cervical screw fixation in pediatric patients, Genesys Spine TiLock Modular Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Genesys Spine TiLock Modular Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
The Genesys Spine TiLock Modular Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Genesys Spine TiLock Modular Spinal System is also intended for the following indications: degenerative disc disease (DDD); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and 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
| Primary | Secondary | |
|---|---|---|
| Submitter's Name: | Genesys Spine | Genesys Spine |
| Submitter's Address: | 1250 Capital of Texas | |
| Highway South | 1250 Capital of Texas | |
| Highway South | ||
| Building Three, Suite 600 | ||
| Austin, Texas 78746 | Building Three, Suite 600 | |
| Austin, Texas 78746 | ||
| Submitter's Telephone: | 512-381-7071 | 512-381-7080 |
| Submitter's Fax: | 800-817-4938 | 800-817-4938 |
| Contact Name: | Brian J. Bergeron | William W. Sowers |
| Date Summary was | ||
| Prepared: | November 15, 2017 | |
| Trade or Proprietary Name: | Genesys Spine TiLock Modular Spinal System | |
| Common or Usual Name: | Spinal Fixation System | |
| Classification: | Class II per: | |
| 21 CFR 888.3050 – Spinal interlaminal fixation orthosis | ||
| 21 CFR 888.3060 – Spinal intervertebral body fixation | ||
| orthosis | ||
| 21 CFR 888.3070 – Thoracolumbosacral pedicle screw | ||
| system | ||
| Product Codes: | NKB, KWP, KWQ | |
| Classification Panel: | Orthopedic Devices Panel | |
| Legally Marketed | ||
| (unmodified) devices to | ||
| Which Substantial | ||
| Equivalence is Claimed: | Primary Predicate: | |
| TiLock² Spinal System (Genesys Spine - K161914) | ||
| Additional Predicate(s): | ||
| TiLock² Spinal System (Genesys Spine - K171838) | ||
| TiLock Pedicle Screw System (Genesys Spine - K100757 | ||
| / K103671) | ||
| MAS PLIF Fixation System (NuVasive - K142737) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine TiLock Modular Spinal System is a spinal system that consists of a variety screws, lock screws, rods and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The TiLock Modular Spinal System implants are manufactured from titanium alloy per ASTM F136 and F1472 and Cobalt Chrome per ASTM F1537.
4
INDICATIONS FOR USE
The Genesys Spine TiLock Modular Spinal System is intended for the following indications:
The Genesys Spine TiLock Modular Spinal System is intended for posterior, noncervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, 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 posterior thoracic, lumbar, and sacral spine: degenerative disc disease (DDD); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used for posterior non-cervical screw fixation in pediatric patients, Genesys Spine TiLock Modular Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Genesys Spine TiLock Modular Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
The Genesys Spine TiLock Modular Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Genesys Spine TiLock Modular Spinal System is also intended for the following indications: degenerative disc disease (DDD); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
TECHNICAL CHARACTERISTICS
The Genesys Spine TiLock Modular Spinal System is comprised of inter-changeable Tulip heads, polyaxial screws (solid and cannulated) in various lengths and diameters, lock screws, and rods in various lengths. The TiLock Modular cannulated polyaxial screws may be implanted via a conventional (open) technique or with an over-the-wire technique. Manual instrumentation for implantation of the system is available for both techniques. The over-the-wire procedure is performed using k-wires and fluoroscopy. The implantable components are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F136 and cobalt-chromium-molybdenum alloy per ASTM F1537.
5
PERFORMANCE DATA
Nonclinical testing was performed to demonstrate that the subject Genesys Spine TiLock Modular Spinal System is substantially equivalent to other predicate device. The following testing was performed:
- Static Compression Bending per ASTM F1717 ●
- o Dynamic Compression Bending per ASTM F1717
- Static Torsion per ASTM F1717 ●
- Tulip Pull-off per ASTM F1798 ●
The results demonstrate that the subject Genesys Spine TiLock Modular Spinal System is substantially equivalent to the predicate.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine TiLock Modular Spinal System is substantially equivalent to legally marketed predicate devices for its intended use.