(85 days)
Not Found
No
The device description focuses on the mechanical components (screws, rods, hooks, connectors) of a spinal fixation system. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies are mechanical tests (ASTM F1717).
Yes.
The device is intended to promote fusion of the cervical spine and cervicothoracic junction, and is indicated for various medical conditions such as spondylolisthesis, spinal stenosis, and fracture/dislocation, which signifies its therapeutic purpose.
No
The device description and intended use indicate that this is a surgical implant system designed to promote spinal fusion and stabilization, not to diagnose a condition.
No
The device description explicitly details physical components made of Titanium alloy, such as rods, screws, and hooks, which are implanted in the spine. This indicates it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to promote fusion and provide stabilization in the cervical and cervicothoracic spine. This is a therapeutic device used in vivo (within the body).
- Device Description: The description details physical components like screws, rods, hooks, and connectors made of titanium alloy. These are all components of a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, the Reliance Posterior Cervical-Thoracic System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following:
· ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- spondylolisthesis
- · spinal stenosis
- fracture/dislocation
- · revision of previous cervical spine surgery
- tumors
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine. Pedicle screws are intended for placement only in T1-T3 as a means of anchoring the system.
Product codes
KWP, MNH, MNI
Device Description
The Reliance Posterior Cervical-Thoracic System contains posterior spinal attachment elements in a variety of configurations based upon rod diameter. These include a Titanium alloy based Ø3.5mm rod configuration, a Titanium alloy based Ø4.0mm rod configuration and a Titanium alloy based 04.5mm rod configuration. All configurations, regardless of rod size, are available in 03.5mm, 04.0mm, and 04.5mm major screw diameters. These screw diameters are offered in lengths ranging from 10mm to 20mm, with the 04.0mm, and 04.5mm available up to 50mm. All of these screws are available in both mono-axial options. The polyaxial screws in all of these configurations have an internal taper bushing that circumferentially grasps the rod when the device is locked. Additionally, both the mono-axial and poly-axial screws have a double lead thread.
In addition to the screw sizes mentioned above, reduction-tabbed screws are also available. The reduction-tabbed screws are available in all of the previously mentioned sizes. The Reliance Posterior Cervical-Thoracic System also offers a series of crosslink connectors. Furthermore, the Reliance Posterior Cervico-Thoracic System includes a series of hooks for attaching to the posterior elements of the cervico-thoracic spine. All of the components discussed above are " fabricated from Titanium alloy and should not be used with implants of different materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and cervicothoracic junction (C1-T3), upper thoracic spine (T1-T3)
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)
The Reliance Posterior Cervical-Thoracic System has undergone Non-Clinical Testing including Static Compressive, Static Torsion, Dynamic Compressive and Dynamic Torsion in accordance with ASTM F1717. The Reliance Posterior Cervical-Thoracic System is substantially equivalent to the predicate devices. Additionally, the Reliance Cervical Plate System is substantially equivalent to the predicate devices in terms of sterilization and biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003780, K092295, K083073, K052201
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
K122-292
page 1 of 2
OCT 2 4 2012
510(k) Summary
08 October 2012
Reliance Medical Systems, LLC PO Box 1693 Bountiful, UT 84010 Telephone: 801-295-3280 Fax: 801-294-0079
Bret M. Berry Contact: Member-Manager
Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name:
Spinal Fixation Device Reliance Posterior Cervical-Thoracic System Spinal Interlaminal Fixation Orthosis (per 21 CFR 888.3050) KWP, MNH, MNI
Product Code:
Substantial Equivalence
The Reliance Posterior Cervical-Thoracic System is substantially equivalent to the legally marketed Medtronic Vertex Reconstruction System (K003780), Pioneer Surgical Posterior Cervical Thoracic System (K092295), the Theken Atoll Cervico-Thoracic System (K083073), and the Alphatec Solanas Posterior Stabilization System (K052201). The Reliance Posterior Cervical-Thoracic System is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and strength.
Device Description
The Reliance Posterior Cervical-Thoracic System contains posterior spinal attachment elements in a variety of configurations based upon rod diameter. These include a Titanium alloy based Ø3.5mm rod configuration, a Titanium alloy based Ø4.0mm rod configuration and a Titanium alloy based 04.5mm rod configuration. All configurations, regardless of rod size, are available in 03.5mm, 04.0mm, and 04.5mm major screw diameters. These screw diameters are offered in lengths ranging from 10mm to 20mm, with the 04.0mm, and 04.5mm available up to 50mm. All of these screws are available in both mono-axial options. The polyaxial screws in all of these configurations have an internal taper bushing that circumferentially grasps the rod when the device is locked. Additionally, both the mono-axial and poly-axial screws have a double lead thread.
In addition to the screw sizes mentioned above, reduction-tabbed screws are also available. The reduction-tabbed screws are available in all of the previously mentioned sizes. The Reliance Posterior Cervical-Thoracic System also offers a series of crosslink connectors. Furthermore, the Reliance Posterior Cervical-Thoracic System includes a series of hooks for attaching to the posterior elements of the cervico-thoracic spine. All of the components discussed above are " fabricated from Titanium alloy and should not be used with implants of different materials.
Intended Use/Indications for Use
Page 21 of 35
1
page 2 of 2.
The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following:
· ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- spondylolisthesis
- · spinal stenosis
- fracture/dislocation
- · revision of previous cervical spine surgery
- tumors
The use of the polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine. Pedicle screws are intended for placement only in T1-T3 as a means of anchoring the system.
Performance Data and Substantial Equivalence
The Reliance Posterior Cervical-Thoracic System has undergone Non-Clinical Testing including Static Compressive, Static Torsion, Dynamic Compressive and Dynamic Torsion in accordance with ASTM F1717. The Reliance Posterior Cervical-Thoracic System is substantially equivalent to the predicate devices. Additionally, the Reliance Cervical Plate System is substantially equivalent to the predicate devices in terms of sterilization and biocompatibility.
2
Image /page/2/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 abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Reliance Medical Systems, LLC % Mr. Bret M. Berry Member-Manager 545 West 500 South, Suite 100 Bountiful, Utah 84010
Re: K122292
Trade/Device Name: Reliance Posterior Cervical-Thoracic System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNH, MNI Dated: October 09, 2012 Received: October 10, 2012
Dear Mr. Berry:
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
OCT
24 2012
3
Page 2 - Mr. Bret M. Berry
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,
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K122292
Device Name: Reliance Posterior Cervical-Thoracic System
Indications for Use:
The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following: · ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- spondylolisthesis
- · spinal stenosis
- · fracture/dislocation
- · revision of previous cervical spine surgery
- tumors
The use of the mini polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine. Pedicle screws are intended for placement only in T1-T3 as a means of anchoring the system.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Page / of /
Sign-Off) Vision of Surgical, Orthopedic, /and Restorative Devices
K122292 510(k) Number_
Page 18 of 234