(29 days)
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as "intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of... instabilities of the thoracic, lumbar, and sacral spine," which is a therapeutic purpose.
No
The device, the TiLock2 Spinal System, is described as providing immobilization of spinal segments as an adjunct to fusion for treating various spinal instabilities. This indicates it is a therapeutic device used in treatment, not a diagnostic device used for identifying or characterizing a disease.
No
The device description clearly lists various hardware components such as screws, connectors, washers, hooks, and rods, indicating it is a physical implant system, not software.
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 TiLock Spinal System is for providing immobilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions. This is a surgical implant used directly on the patient's body.
- Device Description: The device description lists components like screws, rods, connectors, etc., which are all physical implants and surgical tools.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the human body to diagnose or monitor medical conditions. The TiLock Spinal System is a surgical implant used for structural support and stabilization within the body.
N/A
Intended Use / Indications for Use
The TiLock2 Spinal System is intended 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 of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis: spinal tumor; and failed previous fusion (pseudarthrosis).
Product codes
NKB, KWP
Device Description
The Genesys Spine TiLock2 Spinal System is offered in polyaxial screws (solid and cannulated) and monoaxial screws in various lengths and diameters, offset connectors, washers, hooks, rod-to-rod connectors, lock screws, crosslinks, and rods in various lengths and materials.
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
Not Required. There was no change to the cleared system implants or the manner in which they are used. The instrument additions mimic previously cleared instruments with minor alterations.
Key Metrics
Not Found
Predicate Device(s)
K152039, K100757, K103671, K122145
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
July 19, 2017
Genesys Spine Mr. William W. Sowers VP Quality & Regulatory 1250 Capital of Texas Highway South Building Three, Suite 600 Austin, Texas 78746
Re: K171838
Trade/Device Name: TiLock2 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: June 16, 2017 Received: June 20, 2017
Dear Mr. Sowers:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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) K171838
Device Name
TiLock2 Spinal System
Indications for Use (Describe)
The TiLock? Spinal System is intended 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 of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis: spinal tumor; and failed previous fusion (pseudarthrosis).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Submitter's Name: | Genesys Spine |
|---|---|
| Submitter's Address: | 1250 Capital of Texas Highway South |
| Building Three, Suite 600 | |
| Austin, Texas 78746 | |
| Submitter's Telephone: | 512-381-7080 |
| Submitter's Fax: | 800-817-4938 |
| Contact Name: | William W. Sowers |
| Date Summary was | |
| Prepared: | June 16, 2017 |
| Trade or Proprietary Name: | TiLock2 Spinal System |
| Common or Usual Name: | Spinal Fixation System |
| Classification Name: | Thoracolumbosacral Pedicle Screw System, |
| Spinal Interlaminal Fixation Orthosis | |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3070 – Thoracolumbosacral Pedicle Screw |
| System | |
| 21 CFR 888.3050 – Spinal Interlaminal Fixation Orthosis | |
| Product Codes: | NKB, KWP |
| Classification Panel: | Orthopedic Devices Panel |
| Legally Marketed | |
| (unmodified) devices to | |
| Which Substantial | |
| Equivalence is Claimed: | Primary Predicate: |
| TiLock2 Spinal System (Genesys Spine - K152039) | |
| Additional Predicate(s): | |
| TiLock Pedicle Screw System (Genesys Spine - K100757 / K103671) | |
| LANX Spinal Fixation System (LANX - K122145) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The intent of this Special 510(k) is threefold:
-
- To add the KWP product code to the system
-
- Clarify the system classification is now Class II in accordance with Docket No. FDA-2014-N-1205
-
- Add / revise system instrumentation
The Genesys Spine TiLock2 Spinal System is offered in polyaxial screws (solid and cannulated) and monoaxial screws in various lengths and diameters, offset connectors, washers, hooks, rod-to-rod connectors, lock screws, crosslinks, and rods in various lengths and materials.
4
INDICATIONS FOR USE
The TiLock 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 the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
TECHNICAL CHARACTERISTICS
The Genesys Spine TiLock- Spinal System is comprised of polyaxial screws (solid and cannulated) and monoaxial screws in various lengths and diameters, offset connectors, washers, hooks, rod-to-rod connectors, lock screws, crosslinks, and rods in various lengths. The TiLock System only allows the placement of 5.5mm titanium or cobalt chromium 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 TiLock- tulips are available in three (3) configurations: standard, break off and extended tab. The extended tab tulips are only assembled utilizing cannulated screws, as it is intended to facilitate screw insertion during minimally invasive procedures. The TiLock implantable components are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F136 and cobalt-chromium-molybdenum alloy per ASTM F1537.
The Genesys Spine TiLock2 Spinal System implants remain unchanged from their previously cleared configuration outlined in K100757, K103034, and K152039. As such no new testing or analysis is required. In addition, since all of the implants have been previously cleared they do not present any new risks to mechanical strength or performance. The devices in the TiLock' Spinal System are utilized in the same manner as the predicate devices.
PERFORMANCE DATA
Not Required. There was no change to the cleared system implants or the manner in which they are used. The instrument additions mimic previously cleared instruments with minor alterations.
CONCLUSION
The technology and characteristics of the TiLock2 Spinal System remains unchanged. Laminar hooks were previously cleared per K152039. This submission adds the KWP product code corresponding to spinal interlaminal fixation orthosis. The added system instrumentation are all derivatives of previously cleared system devices and do not add any new technology or novel characteristics. As a result, the modified TiLock Spinal System is considered substantially equivalent to the previous Genesys Spine TiLock / TiLock2 Systems (Genesys Spine - K100757 / K103671 / K152039) as well as the LANX Spinal Fixation System (K122145).