(117 days)
No
The device description focuses on mechanical components for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended to immobilize and stabilize spinal segments as an adjunct to fusion for various conditions, which aligns with the definition of a therapeutic device designed to treat or manage a medical condition.
No
Explanation: The GSO PCT Spinal System is described as an implantable mechanical system (rods, screws, hooks, and connecting components) intended for immobilization and stabilization of spinal segments as an adjunct to fusion. Its purpose is to physically support the spine and promote healing, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it consists of rods, screws, hooks, and connecting components made from titanium, which are physical hardware implants.
Based on the provided information, the GSO PCT Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- GSO PCT Spinal System Function: The GSO PCT Spinal System is a surgical implant designed to provide mechanical support and stabilization to the spine as an adjunct to fusion. It is physically implanted into the patient's body.
- Intended Use: The intended use clearly states it's for "immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion." This is a therapeutic and structural function, not a diagnostic one performed on a specimen outside the body.
- Device Description: The description details rods, screws, hooks, and connecting components made of titanium, which are all physical implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the GSO PCT Spinal System falls under the category of a surgical implant or spinal fixation system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GSO PCT Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO PCT Spinal System should be removed after fusion.
The GSO PCT Spinal System is intended to promote fusion of the cervical spine and cervico-thoracic junction (C1-T3), and is indicated for the following:
- Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture or dislocation
- Revision of previous cervical or cervico-throracic spine surgery
- Tumors
The use of multi-axial pedicle screws is limited to placement in the upper thoracic spine (T1-T3) for the purpose of anchoring the construct. The multi-axial pedicle screws are not intended to be placed in the cervical spine.
Product codes
KWP
Device Description
The GSO PCT Spinal System consists of rods, screws, hooks, and connecting components that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are attached to the spine posteriorly by means of screws and/or hooks joined with rods. Cross connector components are used to attach two rods in parallel. The GSO PCT Spinal System can be installed with any suitable instrumentation.
The GSO PCT Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136. Devices are available in various diameters, lengths and sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and cervico-thoracic junction (C1-T3), upper thoracic spine (T1-T3)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing conducted according to ASTM F1717 demonstrates that the GSO PCT Spinal System has sufficient strength for its intended use.
Clinical testing was not necessary to demonstrate the substantial equivalence of the GSO PCT Spinal System to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K080828, K033961, K080143, K032394, K070966
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.
0
K091359
| 1. | Applicant/Sponsor: | Gold Standard Orthopaedics, LLC.
1226 Rowan St.
Louisville, KY 40203 |
|----|-----------------------|----------------------------------------------------------------------------------|
| 2. | Contact Person: | David Baughman
President
David06@Baughmangroup.com
Phone (502) 581-8770 |
| 3. | Proprietary Name: | GSO PCT Spinal System |
| 4. | Common Name: | Posterior Spinal Implants |
| 5. | Classification Names: | 21 CFR 888.3050 - Spinal interlaminal fixation
orthosis |
510/K) SIIMMARY
SFP - 2 2009
Legally Marketed Devices to which Substantial Equivalence is claimed: 6.
- . Mountaineer OCT Spinal System - Depuy Spine, Inc. (14080828)
- . Altius OCT System - Interpore Cross International (K033961)
- . OASYS System - Stryker Spine (K080143, K032394)
- . GS1 Spinal System - Gold Standard Orthopaedics, LLC (K070966)
7. . Device Description:
The GSO PCT Spinal System consists of rods, screws, hooks, and connecting components that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are attached to the spine posteriorly by means of screws and/or hooks joined with rods. Cross connector components are used to attach two rods in parallel. The GSO PCT Spinal System can be installed with any suitable instrumentation.
The GSO PCT Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136. Devices are available in various diameters, lengths and sizes.
8-Intended Use:
The GSO PCT Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO PCT Spinal System should be removed after fusion.
1
In all cases, instrumentation must be at least 1 cm from any major vessel.
-
ੇ. Indications:
The GSO PCT Spinal System is intended to promote fusion of the cervical spine and cervico-thoracic junction (C1-T3), and is indicated for the following: -
Degenerative disc disease (as defined by neck pain of discogenic origin with 1 degeneration of the disc confirmed by history and radiographic studies)
-
- Spondylolisthesis
-
- Spinal stenosis
-
- Fracture or dislocation
-
- Revision of previous cervical or cervico-throracic spine surgery
-
- Tumors
The use of multi-axial pedicle screws is limited to placement in the upper thoracic spine (T1-T3) for the purpose of anchoring the construct. The multi-axial pedicle screws are not intended to be placed in the cervical spine.
-
- Summary of Technologies/Substantial Equivalence:
The GSO PCT Spinal System has a similar indications and design and is manufactured from the same materials as the Mountaineer OCT Spinal System -Depuy Spine, Inc. (K080828), the Altius OCT System - Interpore Cross International (K033961), and the OASYS System -- Stryker Spine (K080143, K032394)
- Summary of Technologies/Substantial Equivalence:
11. Non-Clinical Testing:
Mechanical testing conducted according to ASTM F1717 demonstrates that the GSO PCT Spinal System has sufficient strength for its intended use.
12. Clinical Testing:
র্বা
Clinical testing was not necessary to demonstrate the substantial equivalence of the GSO PCT Spinal System to the predicate devices.
page 2 of 2
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Gold Standard Orthopaedics; LLC % Mr. David Baughman President 1226 Rowan Street Louisville, Kentucky 40203
SEP - 2 2009
Re: K091359
Trade/Device Name: GSO PCT Spinal System
Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: August 23, 2009 Received: August 27, 2009
Dear Mr. Baughman:
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.
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. J
3
Page 2 - Mr. David Baughman
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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Barbara Buehrig
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2. INDICATIONS FOR USE
510(k) Number (if known): K091359
Device Name: GSO PCT Spinal System
Indications for Use:
The GSO PCT Spinal System is intended to promote fusion of the cervical spine and cervico-thoracic junction (C1-T3), and is indicated for the following:
-
- Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis ri
-
- Spinal stenosis
- Fracture or dislocation 4.
- Revision of previous cervical or cervico-throracic spine surgery 5.
- (. Tumors
The use of multi-axial pedicle screws is limited to placement in the upper thoracic spine (T1-T3) for the purpose of anchoring the construct. The multi-axial pedicle screws are not intended to be placed in the cervical spine.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Karen S. Bury for AKS MXM
(Division Sign-Off)
Division of Surgical
Page _ 1 of _ 1
Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K091359