(29 days)
No
The summary describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is used to immobilize and stabilize spinal segments as an adjunct to fusion, treating conditions like DDD, spondylolisthesis, and fractures.
No
Explanation: The provided text describes the Gibralt Spinal System as a surgical implant designed to "promote fusion of the cervical spine, and the thoracic spine," and "immobilize and stabilize spinal segments as an adjunct to fusion." It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "top-loading spinal fixation system comprising a range of polyaxial screws, rods, hooks, and various connectors" and is manufactured from "titanium alloy per ASTM F136," indicating it is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Gibralt Spinal System is used to "promote fusion of the cervical spine, and the thoracic spine" and "provide stabilization to promote fusion following reduction of fracture/dislocation or trauma." This describes a surgical implant used directly on the patient's body for structural support and stabilization.
- Device Description: The device is described as a "top-loading spinal fixation system comprising a range of polyaxial screws, rods, hooks, and various connectors." These are all components of a surgical implant.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. The Gibralt Spinal System does not perform any such tests.
The device is a surgical implant used for spinal fixation and fusion, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.
The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.
This system can be used independently or in conjunction with Exactech 5.5mm or 6.0mm rod-based Thoraco-Lumbar Pedicle Screw Systems.
Product codes
KWP
Device Description
Gibralt Rod-to-Rod Cross Connectors represent a line extension to the Gibralt Spinal System. The Gibralt Spinal System is a top-loading spinal fixation system comprising a range of polyaxial screws, rods, hooks, and various connectors. Gibralt Spinal System devices are used by surgeons to immobilize and stabilize spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine.
As with other Gibralt System cross-connectors, Gibralt Rod-to-Rod Cross Connectors are designed to increase the rigidity of Gibralt Spinal System constructs. Gibralt Rod-to-Rod Cross Connectors can be used at any point along a Gibralt Spinal System rod, where previous cross connectors can only be used at connection points in a system construct. This line extension is proposed to provide surgeons with additional options for stabilizing and/or immobilizing spinal segments as an adjunct to spinal fusion.
Like all Gibralt Spinal System components, the proposed Gibralt Rod-to-Rod Cross Connectors are manufactured from titanium alloy per ASTM F136. All implantable Gibralt Spinal System components are provided non-sterile, and must be steam sterilized by the hospital prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, thoracic spine, (C3-T3)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons, hospital
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)
Bench Testing:
Mechanical properties for Gibralt Rod-to-Rod Cross Connectors were assessed per ASTM F1717-13:
- Static compression bending
- Dynamic compression bend strength
Substantial Equivalence Conclusion:
Detailed device comparison, bench testing, and engineering studies included or referenced in this submission demonstrate the proposed Gibralt Rod-to-Rod Cross Connectors are substantially equivalent to cleared predicate Gibralt Spinal System devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
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K140645 Page 1 of 2
Exactech® Gibralt® Rod-to-Rod Cross Connectors Special 510(k) - 510(k) Summary of Safety and Effectiveness
Sponsor: Exactech, Inc. 2320 N.W. 66th Court Gainesville, FL 32653
Phone: (352) 327-4762 (352) 378-2617 Fax:
FDA Establishment Number 1038671
Contact: Patrick Hughes Senior Regulatory Affairs Specialist
Date: March 12, 2014
Trade of Proprietary or Model Name(s): Exactech® Gibralt® Rod-to-Rod Cross Connectors
Common Name: Spinal Fixation System
Classification Name:
- 21 CFR 888.3050 Spinal interlaminal fixation orthosis, Class II, Product . Code: K WP - appliance, fixation, spinal interlaminal
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K110197 | Gibralt Spinal System | Exactech, Inc |
Indications for Use:
When intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.
The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.
This system can be used independently or in conjunction with Exactech 5.5mm or 6.0mm rod-based Thoraco-Lumbar Pedicle Screw Systems.
APR 1 1 2014
1
Exactech® Gibralt® Rod-to-Rod Cross Connectors Special 510(k) - 510(k) Summary of Safety and Effectiveness
Device Description:
Gibralt Rod-to-Rod Cross Connectors represent a line extension to the Gibralt Spinal System. The Gibralt Spinal System is a top-loading spinal fixation system comprising a range of polyaxial screws, rods, hooks, and various connectors. Gibralt Spinal System devices are used by surgeons to immobilize and stabilize spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine.
As with other Gibralt System cross-connectors, Gibralt Rod-to-Rod Cross Connectors are designed to increase the rigidity of Gibralt Spinal System constructs. Gibralt Rod-to-Rod Cross Connectors can be used at any point along a Gibralt Spinal System rod, where previous cross connectors can only be used at connection points in a system construct. This line extension is proposed to provide surgeons with additional options for stabilizing and/or immobilizing spinal segments as an adjunct to spinal fusion.
Like all Gibralt Spinal System components, the proposed Gibralt Rod-to-Rod Cross Connectors are manufactured from titanium alloy per ASTM F136. All implantable Gibralt Spinal System components are provided non-sterile, and must be steam sterilized by the hospital prior to use.
Bench Testing:
Mechanical properties for Gibralt Rod-to-Rod Cross Connectors were assessed per ASTM F1717-13:
- · Static compression bending
- · Dynamic compression bend strength
Substantial Equivalence Conclusion:
Detailed device comparison, bench testing, and engineering studies included or referenced in this submission demonstrate the proposed Gibralt Rod-to-Rod Cross Connectors are substantially equivalent to cleared predicate Gibralt Spinal System devices.
2
Image /page/2/Picture/0 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 a stylized symbol that resembles an abstract human figure embracing or protecting another form.
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
April 11, 2014
Exactech, Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K140645
Trade/Device Name: Exactech® Gibralt® Rod-to-Rod Cross Connectors Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: March 12, 2014 Received: March 13, 2014
Dear Mr. Hughes:
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. Patrick Hughes
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/Resourcesfor You/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/MedicalDeviccs/ResourcesforYou/Industrv/default.htm.
Sincerely yours.
Ronald R. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Gibralt Spinal System Rod-to-Rod Connectors
Indications for Use (Describe)
When intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, failed previous fusion and/or uniors. The hooks and rods are also intended to provide stabilization to promote fusion of fracturedislocation of trauma in the cervice/upper thoracic (C3-T3) spine.
The use of polyazial screws is limited to placement in T1-T3 in treating thoracic conditions only. "Polyaxial screws are not intended to be placed in the cervical spine.
This system can be used independently or in conjunction with Exacted Thorsco-Lumbar Pedicle Screw Systems.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE CONTRACT FOR FOR FOR FOR FOR USE ONLY PRODUCTION OF THE SERVED THE SERVED Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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