(122 days)
Not Found
No
The 510(k) summary describes a mechanical implant (facet screw) and associated instrumentation for spinal fusion. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are biomechanical, not related to algorithmic performance.
Yes.
The device is indicated for the posterior surgical treatment of various spinal conditions (DDD, spondylolisthesis, spondylolysis, fracture, or failed previous fusion) and is intended to provide posterior fixation as an aid to fusion, thus restoring health or alleviating symptoms.
No
The device is described as a "facet screw device intended to provide posterior fixation as an aid to fusion" for surgical treatment. It is a physical implant used in treatment, not a device that analyzes data or provides a diagnosis.
No
The device description clearly states it is a "new facet screw device" and describes physical components made of titanium alloy, along with an instrumentation system for implantation. This indicates a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Gibralt Spine System Facet Screw is a physical implantable device (a screw) used in surgical procedures to provide fixation in the spine. It is not used to test samples from the body.
- Intended Use: The intended use is for posterior surgical treatment and fixation of the spine, not for diagnostic testing.
The provided information clearly describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Gibralt Spine System Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spondylolysis, fracture, or failed previous fusion.
Product codes
MRW
Device Description
The proposed Gibralt Spine System Facet Screw is a new facet screw device intended to provide posterior fixation as an aid to fusion. The Gibralt Spine System Facet Screw components are available in a variety of sizes and are manufactured from titanium alloy per ASTM F136.
The system components are provided non-sterile. The products must be steam sterilized by the hospital prior to use.
The Gibralt Spine System Facet Screw is provided with a complete instrumentation system to assist the surgeon in implantation according to a traditional open surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-S1 (inclusive) spinal levels
Indicated Patient Age Range
Not Found
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)
A biomechanical assessment comparing Gibralt Facet Screw mechanical performance to cited predicate devices.
The results of mechanical testing and analysis demonstrate the proposed device is substantially equivalent to cited predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073515, K092568, K083442, K061041, K012773, K071420
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
KIL2097
NOV 2 1 2011
Exactech® Gibralt" Spine System Facet Screw Traditional 510(k)
510(k) Summary
| Company: | Exactech ®, Inc
2320 NW 66th Court
Gainesville, FL 32653 |
|----------------------|------------------------------------------------------------------------------------------------------|
| Date: | October 5, 2011 |
| Contact Person: | Vladislava Zaitseva
Regulatory Affairs Specialist
Phone: (352) 377-1140
Fax: (352) 378-2617 |
| Proprietary Name: | Exactech® Gibralt™ Spine System Facet Screw |
| Common Name: | Facet screw spinal device |
| Classification Name: | Unclassified |
| Product Code: | MRW |
Legally Marketed Devices to Which Substantial Equivalence Is Claimed
- TranS1 Facet Screw (K073515) .
- Spartan S3 Facet System (K092568) ●
- Corridor Fixation System (K083442) .
- . US Spine Facet Fixation System (K061041)
- DePuy AcroMed Discovery Facet Screw (K012773)
- SpineFrontier Chameleon Fixation System (K071420) .
Device Description
The proposed Gibralt Spine System Facet Screw is a new facet screw device intended to provide posterior fixation as an aid to fusion. The Gibralt Spine System Facet Screw components are available in a variety of sizes and are manufactured from titanium alloy per ASTM F136.
The system components are provided non-sterile. The products must be steam sterilized by the hospital prior to use.
The Gibralt Spine System Facet Screw is provided with a complete instrumentation system to assist the surgeon in implantation according to a traditional open surgical procedure.
Indications for Use
The Gibralt Spine System Facet Screw is indicated for posterior surgical treatment at C2-$1 (inclusive) spinal levels for the following: DDD (neck pain of discogenic origin with
1
Exactech® Gibralt™ Spine System Facet Screw Traditional 510(k)
- A biomechanical assessment comparing Gibralt Facet Screw mechanical . performance to cited predicate devices.
The results of mechanical testing and analysis demonstrate the proposed device is substantially equivalent to cited predicates.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 2 1 2011
Exactech, Inc. % Ms. Vladislava Zaitseva 2320 N.W. 66th Court Gainesville, Florida 32653
Rc: K112097
Trade/Device Name: Gibralt Spine Systems Facet Screw Regulatory Class: Unclassified Product Code: MR W Dated: October 05, 2011 Received: October 12, 2011
Dear Ms. Zaitseva:
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
3
Page 2 - Ms. Vladislava Zaitseva
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.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Erin S. Keith
for Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exactech® Gibralt™ Spine System Facet Screw Traditional 510(k)
Indications for Use Statement
510(k) Number:
KII2097
Device Name: Exactech® Gibralt™ Spine System Facet Screw
INDICATIONS FOR USE:
The Gibralt Spine System Facet Screw is indicated for the posterior surgical treatment at C2- S1 (inclusive) spinal levels for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spondylolysis, fracture, or 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 - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Div/sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K112097 510(k) Number_