(131 days)
Not Found
No
The device description and performance studies focus solely on the mechanical components and their physical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as providing "immobilization and stabilization of spinal segments" and is intended for treating various "instabilities or deformities" of the spine, which are therapeutic actions.
No
The device, the TIGER® Spine System, is a posterior spinal fixation system intended for immobilization and stabilization of spinal segments, as an adjunct to fusion. It consists of hardware components like pedicle screws and rods, and its purpose is therapeutic, not diagnostic.
No
The device description clearly states it is a "multiple component, posterior spinal fixation system which consists of pedicle screws, cannulated pedicle screws, posted pedicle screws, rods, crossconnectors, locking cap screws, hooks, and lateral offset connectors," all made from titanium alloy. This indicates a physical hardware device, not software only.
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 TIGER® Spine System is for "immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion." This describes a surgical implant used in vivo (within the body) to treat structural issues.
- Device Description: The device is described as a "multiple component, posterior spinal fixation system" consisting of physical components like screws, rods, and connectors made from titanium alloy. These are physical implants, not reagents, instruments, or software used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (blood, urine, tissue, etc.) to provide diagnostic information. The purpose is mechanical support and stabilization.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The TIGER® Spine System does not fit this description.
N/A
Intended Use / Indications for Use
The TIGER® Spine 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 (T)-S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history of and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
Product codes
MNI, MNH, NKB, KWP
Device Description
The TIGER® Spine System is a multiple component, posterior spinal fixation system which consists of pedicle screws, cannulated pedicle screws, posted pedicle screws, rods, crossconnectors, locking cap screws, hooks, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine (T)-S1/Ileum
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
The TIGER® Posted Spine System constructs were tested in static axial compression, static torsion, and dynamic axial compression per ASTM F1717-11a. The TIGER® Spine System Hook constructs were tested in static axial and torsion grip per ASTM F1798-97. The TIGER® Spine System Cannulated Screw constructs were tested in static axial compression, static torsion, and dynamic axial compression per ASTM F1717-11a.
Key Metrics
Not Found
Predicate Device(s)
K110321, K120696, K113058, K121728, K101070, K024348, K010576, K014137, K001357, K992333, K991721, K990303, K973683, K021170
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
510(K) SUMMARY
| Submitter's Name: | CoreLink, LLC |
|---|---|
| Submitter's Address: | 7606 Forsyth Blvd |
| Clayton, MO 63105 | |
| Submitter's Telephone: | 314-863-5401 |
| Submitter's Fax: | 636-680-5715 |
| Authorized Contact Name: | Meredith May, Authorized Contact Person |
| Contact's Telephone: | 719-337-7579 |
| Contact's Email: | MMay@EmpiricalTesting.com |
| Date Summary was | |
| Prepared: | 12-Apr-13 |
| Trade or Proprietary Name: | TIGER® Spine System |
| Common or Usual Name: | Orthosis, Spinal Pedicle Fixation |
| Orthosis, Spondylolisthesis Spinal Fixation | |
| Orthosis , Spinal Interlaminal Fixation | |
| Classification: | Class III per 21 CFR §888.3070 and §888.3050 |
| Product Codes: | MNI, MNH, NKB, KWP |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | TIGER® Spine System (K110321, K120696. K113058, |
| and K121728) | |
| Depuy Expedium Offset (K101070) | |
| Depuy Monarch (K024348 and K010576) | |
| EBI Omega 21 (K014137, K001357, K992333, K991721, | |
| K990303, and K973683) | |
| Medtronic Sofamor Danek TSRH-3D (K021170) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The TIGER® Spine System is a multiple component, posterior spinal fixation system which consists of pedicle screws, cannulated pedicle screws, posted pedicle screws, rods, crossconnectors, locking cap screws, hooks, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.
CHANGE FROM PREDICATE:
The purpose of this submission is to make modifications/additions to the components of the TIGER® Spine System cleared in K110321, K120696, K113058, and K121728. The standard
Tiger® Spine System Line Extension
1
construct is modified by the addition of hooks, cross-connectors, cannulated screws, and posted screws.
TECHNOLOGICAL CHARACTERISTICS:
The intended use and technological features of the modifications/additions to the components of the TIGER® Spine System do not substantially differ from the legally marketed predicate devices, which are the TIGER® Spine System (K110321. K120696, K113058, and K121728), Depuy Expedium Offset (K101070). Depuy Monarch (K024348 and K010576), EBI Omega 21 (K014137, K001357, K992333, K991721, K990303, and K973683), and Medtronic Sofamor Danek TSRH-3D (K021170). The predicate devices and the subject additions to the Tiger system are designed for posterior stabilization to provide immobilization and stabilization of spinal segments as an adjunct to fusion.
INDICATIONS FOR USE
The TIGER® Spine 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 (T)-S1/Ileum): degenerative disc discase (defined as discogenic back pain with degeneration of disc confirmed by history of and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment. fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
PERFORMANCE DATA
The TIGER® Posted Spine System constructs were tested in static axial compression, static torsion, and dynamic axial compression per ASTM F1717-11a. The TIGER® Spine System Hook constructs were tested in static axial and torsion grip per ASTM F1798-97. The TIGER® Spine System Cannulated Screw constructs were tested in static axial compression, static torsion, and dynamic axial compression per ASTM F1717-11a.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that TIGER® Spine System is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge at the bottom.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
CoreLink, LLC % Ms. Meredith May Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K131250
Trade/Device Name: TIGER® Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH. KWP Dated: July 18, 2013 Received: July 31, 2013
Dear Ms. May:
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 10 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 notc: 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 cither 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 complics 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
September 10, 2013
3
Page 2 - Ms. Meredith May
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours,
Mark N. Melkerson -S
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Device Name: TIGER® Spine System
510(k) Number: K131250
The TIGER® Spine 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 (T)-S VIlleum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history of and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scollosis, spinal tumor, and failed previous fusion (pscudoarthrosis).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510 (k) Number: Kl31250
Tiger® Spine System Line Extension