(76 days)
Not Found
No
The summary describes a mechanical implant (washers and screws) for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
A therapeutic device is one that treats or cures a disease or condition. This device is intended to stabilize a bone graft and aid in spinal fusion, which is a supportive rather than a therapeutic function.
No
The device is an implant designed to stabilize bone grafts and provide temporary stabilization for spinal fusion, not to diagnose medical conditions.
No
The device description explicitly states it consists of "washers and bone screws," which are physical hardware components, not software.
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 Reliance Buttress Washer System is a temporary implant used to stabilize bone graft and augment spinal fusion. It is a physical device implanted into the body.
- Intended Use: The intended use clearly describes a surgical procedure involving the spine, not a laboratory test on a sample.
The information provided describes a surgical implant, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The Reliance Buttress Washer System is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Product codes
KWO, KWQ
Device Description
The Reliance Buttress Washer System is a temporary implant used to prevent bone graft extrusion. The Reliance Buttress Washer Systems consists of washers and bone screws. The Buttress Washer is also intended to provide stabilization and augment development of a solid spinal fusion. The Buttress Washer fixates to the anterior portion of the thoracolumbar vertebral body, The construct may be employed alone device or with other anterior, anterolateral, or posterior spinal systems made of compatible materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1-S1 (thoracolumbar vertebral body)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K970048, K994122, K041217, K021039, K040130, K061482
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
Bret M. Berry 2647 Cassowary Cir Sandy, UT 84092-7116 801-388-0700 Telephone: 801-294-0079 Fax:
Contact:
Bret M. Berry Member-Manager
Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Regulation Number: Product Code:
Anterior Lumbar Buttress System Reliance Buttress Washer System Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3060 KWO
Substantial Equivalence
The Reliance Buttress Washer is substantially equivalent to the legally marketed Synthes Titanium Locking Plate System (K970048), the Medtronic Sofamor Danek Bone Graft Washer (K994122, K041217), the DePuy BowTi Anterior Buttress Staple System (K021039), the SeaSpine Anterior Lumbar Buttress System (K040130), and the Altiva ALTES™Anterior Buttress Plating System (K061482). The Reliance Buttress Washer is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.
Device Description
The Reliance Buttress Washer System is a temporary implant used to prevent bone graft extrusion. The Reliance Buttress Washer Systems consists of washers and bone screws. The Buttress Washer is also intended to provide stabilization and augment development of a solid spinal fusion. The Buttress Washer fixates to the anterior portion of the thoracolumbar vertebral body, The construct may be employed alone device or with other anterior, anterolateral, or posterior spinal systems made of compatible materials.
Intended Use/Indications for Use
The Reliance Buttress Washer System is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
FEB 13 A
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
FEB 13 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Reliance Medical Systems, LLC % Mr. Bret M. Berry Member-Manager 2647 Cassowary Circle Sandy, UT 84092-7116
Re: K073349
Trade/Device Name: Reliance Buttress Washer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: Nov 21, 2007 Received: Dec 31, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Mr. Bret M. Barry
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark W. Millerson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: _Reliance Buttress Washer System
Indications for Use:
The Reliance Buttress Washer System is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
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)
Auban Muen
Division of General, Restorative, and Neurological Devices
510(k) Number K073349