(108 days)
Not Found
No
The device description and intended use clearly describe a mechanical implant system for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML technology.
Yes
The device is described as "intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion (C2-C7)," acting as a "temporary stabilization" and addressing various medical conditions like degenerative disc disease, trauma, and tumors. Its purpose is to directly treat or mitigate these conditions and support the healing process.
No
Explanation: The device is an implantable system (anterior cervical plate and screws) for spinal fusion, which is used for treatment and stabilization, not for diagnosing medical conditions.
No
The device description clearly states that the system consists of bone plates, bone screws, and associated instruments, all of which are physical hardware components made of titanium alloy and stainless steel. There is no mention of software as a component of this 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 the device is for "anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a system of bone plates, screws, and instruments used for surgical implantation. These are physical devices used to stabilize the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used for structural support and stabilization within the body.
N/A
Intended Use / Indications for Use
The GSO ACP1 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion (C2-C7). The GSO ACP1 Anterior Cervical Plate System is intended for single use only.
The GSO ACP1 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with
- degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- spondylolisthesis
- trauma (including fractures)
- spinal stenosis
- tumors, deformity (defined as kyphosis, lordosis, or scoliosis)
- pseudarthroses, and/or failed previous fusions
WARNING: This device system is intended for anterior cervical interbody fusions only. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The ACPI Anterior Cervical Plate System consists of a variety of anterior cervical spinal bone plates and self-drilling / self-tapping bone screws for fixation of the vertebral body(s) of the cervical spine, using an anterior approach for the development of a cervical spinal fusion (C2-C7), and associated instruments. The bone screws form an interlocked construct on the vertebral bodies. The spinal bone plates include an integrated bone screw locking mechanism consisting of an integrated tab retained by a captive locking screw, covering a portion of the underlying bone screw head to prevent bone screw back-out. The bone screws are self-drilling / self-tapping, in various diameters and lengths, and are available in variable angle and fixed angle configurations. All implant components are ASTM standard, medical implant grade titanium alloy (Ti 6Al-4V ELI). The ACP1 system was designed to be compatible with common surgical instruments available in operating rooms equipped for spine surgery. The device specific instruments are considered to be Class II. The instruments are medical grade stainless steel, some have silicone rubber handles, and they are provided non-sterile. Stainless steel and titanium implant components must not be used together in a construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-C7)
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)
Mechanical testing to determine substantial equivalence to predicate devices was conducted according to ASTM F1717 including static compressive bending, static torsional stiffness, and dynamic axial compression bending.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K021461, K030866, K974885, K040844, K060025, K023133
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
JUL 25 2011
| 1. 510(k) Owner | Gold Standard Orthopaedics, LLC
1226 Rowan Street
Louisville, KY 40203
Contact Information:
Phone: 502-581-8770
Fax: 502-581-1704
Establishment Registration Number: 3006215390
Owner/Operator Number: 10023859 |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Applicant / Sponsor | Gold Standard Orthopaedics, LLC
1226 Rowan Street
Louisville, KY 40203
Contact Information:
Phone: 502-581-8770
Fax: 502-581-1704
Establishment Registration Number: 3006215390
Owner/Operator Number: 10023859 |
| 3. Contact Person | James Ritter
Aquila Consultants, LLC
3415 N. Old Farm Rd. E.
Warsaw, IN 46582
Phone: (574) 527-3256
Fax: (574) 267-7516 |
| 4. Device Proprietary Name | GSO ACP1 Anterior Cervical Plate System |
| 5. Device Common Name | Anterior cervical plate system |
| 6. Date Summary Prepared | March 29, 2011 |
| 7. Classification Name | Spinal intervertebral body fixation orthosis, 21 CFR 888.3060 |
| 8. Legally
Marketed
Predicate Device | The GSO ACP1 Anterior Cervical Plate System was shown to be
substantially equivalent in indications for use, design, mechanical
testing, and materials to other commercially available anterior cervical
plate systems cleared for distribution through the 510(k) process
including:
• Medtronic Sofamor Danek Atlantis Vision Anterior Cervical Plate,
510(k) Number K021461, cleared July 22, 2002
• Synthes Cervical Spine Locking Plate (CSLP), 510(k) Number
K030866 cleared for distribution on April 18, 2003
• Blackstone Medical Anterior Cervical Plate, 510(k)
Number
K974885 cleared for distribution on June 17, 1998
• Life Spine, LLC, NEOTM Cervical Plating System, 510(k) Number
K040844, cleared for distribution on July 23, 2004
• Spinal USA, Slimplicity Anterior Cervical Plate System, 510(k)
Number K060025, cleared for distribution on April 18, 2006
• EBI, L.P., VueLock Anterior Cervical Plate System, 510(k) Number
K023133, cleared for distribution on October 18, 2002 |
| 9. Device
Description | The ACPI Anterior Cervical Plate System consists of a variety of
anterior cervical spinal bone plates and self-drilling / self-tapping bone
screws for fixation of the vertebral body(s) of the cervical spine, using
an anterior approach for the development of a cervical spinal fusion
(C2-C7), and associated instruments. The bone screws form an
interlocked construct on the vertebral bodies. The spinal bone plates
include an integrated bone screw locking mechanism consisting of an
integrated tab retained by a captive locking screw, covering a portion
of the underlying bone screw head to prevent bone screw back-out.
The bone screws are self-drilling / self-tapping, in various diameters
and lengths, and are available in variable angle and fixed angle
configurations. All implant components are ASTM standard, medical
implant grade titanium alloy (Ti 6Al-4V ELI). The ACP1 system was
designed to be compatible with common surgical instruments available
in operating rooms equipped for spine surgery. The device specific
instruments are considered to be Class II. The instruments are medical
grade stainless steel, some have silicone rubber handles, and they are
provided non-sterile.
Stainless steel and titanium implant components must not be used
together in a construct. |
| 10. Intended Use | The GSO ACP1 Anterior Cervical Plate System is intended for anterior
interbody screw fixation of the cervical spine during the development
of a cervical spinal fusion (C2-C7). The GSO ACP1 Anterior Cervical
Plate System is intended for single use only. |
| 11. Indications | The GSO ACP1 Anterior Cervical Plate System is intended for anterior
interbody screw fixation of the cervical spine (C2-C7). The system is
indicated for use in the temporary stabilization of the anterior spine
during the development of cervical spinal fusions in patients with
degenerative disc disease (as defined by neck pain of discogenic origin
with degeneration of the disc confirmed by patient history and
radiographic studies), spondylolisthesis, trauma (including fractures),
spinal stenosis, tumors, deformity (defined as kyphosis, lordosis, or
scoliosis), pseudarthroses, and/or failed previous fusions.
WARNING: This device system is intended for anterior cervical
interbody fusions only. This device is not approved for screw
attachment to the posterior elements (pedicles) of the cervical, thoracic,
or lumbar spine. |
| 12. Summary of
Technologies and
Substantial
Equivalence | The GSO ACP1 Anterior Cervical Plate System is substantially
equivalent in indications for use, design, and materials to other
commercially available anterior cervical plate systems cleared for
distribution through the 510(k) process including: the Medtronic
Sofamor Danek Atlantis Vision Anterior Cervical Plate, 510(k)
Number K021461, cleared July 22, 2002, the Synthes Cervical Spine
Locking Plate (CSLP), 510(k) Number K030866 cleared for
distribution on April 18, 2003, and the Blackstone Medical Anterior
Cervical Plate, 510(k) Number K974885 cleared for distribution on
June 17, 1998, the Life Spine, LLC NEO™ Cervical Plating System,
510(k) Number K040844, cleared for distribution on July 23, 2004, the
Spinal USA Simplicity Anterior Cervical Plate System, 510(k) Number
K060025, cleared for distribution on April 18, 2006, and the EBI
VueLock™ Anterior Cervical Plate System, 510(k) Number K02313,
cleared for distribution on October 18, 2002. |
| 13. Non-Clinical
Testing | Mechanical testing to determine substantial equivalence to predicate
devices was conducted according to ASTM F1717 including static
compressive bending, static torsional stiffness, and dynamic axial
compression bending. |
| 14. Clinical
Testing | Clinical testing was not necessary to demonstrate the substantial
equivalence of the GSO ACP1 Anterior Cervical Plate System to the
Medtronic Sofamor Danek Atlantis Anterior Cervical Plate, the
Synthes Cervical Spine Locking Plate (CSLP), the Blackstone Medical
Anterior Cervical Plate, the Life Spine, LLC NEO™ Cervical Plating
System, the Spinal USA Simplicity Anterior Cervical Plate System,
and the EBI VueLock™ Anterior Cervical Plate System. |
3. 510(k) Summary
1
2
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an eagle-like symbol with three stylized lines representing the wings and body. The symbol is black and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Gold Standard Orthopaedics, LLC % Aquila Consultants, LLC Mr. James Ritter 3415 North Old Farm Road East Warsaw, Indiana 46582
JUL 25 2011
Re: K110990
Trade/Device Name: GSO ACP1 Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis . Regulatory Class: Class II Product Code: K.WQ Dated: June 08, 2011 Received: June 13, 2011
Dear Mr. Ritter:
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 deternination that your device complies with other requirements of the Act
4
Page 2 - Mr. James Ritter
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.
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/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 Biornetrics/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,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
2. Indications for Use Statement
Device Name: GSO ACP1 Anterior Cervical Plate System
Indications For Use:
The GSO ACP1 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with
- · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · spondylolisthesis
- · trauma (including fractures)
- · spinal stenosis
- · tumors, deformity (defined as kyphosis, lordosis, or scoliosis)
- · pseudarthroses, and/or failed previous fusions
WARNING: This device system is intended for anterior cervical interbody fusions only. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar 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)
Page 1 of 1
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
KII0990 510(k) Number_