(151 days)
Not Found
No
The 510(k) summary describes a mechanical spinal implant and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical testing, not algorithmic validation.
Yes
The device is intended to stabilize the spine as an aid to fusion and is indicated for conditions like Spondylolisthesis and Degenerative Disc Disease, which are therapeutic applications.
No
The device is a facet screw system intended to stabilize the spine as an aid to fusion, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it is comprised of "various sized single-use, non-sterile facet screws," which are physical hardware components made of titanium alloy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (facet screws) intended for stabilizing the spine during fusion surgery. This is a physical device used in the body, not a test performed on a sample from the body.
The information provided aligns with a medical device used for surgical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Resolute Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.
Product codes
MRW
Device Description
The Resolute Facet Screw System is comprised of various sized single-use, non-sterile facet screws that are designed to provide bilateral transfacet fixation of the lumbar facet joints. The system consists of titanium alloy (6AL-4v-EU per ASTM F136) screws in fully threaded and partially threaded designs, both of which are cannulated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L1 to 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)
Cantilever testing and engineering analysis was completed on the Resolute Facet Screw System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
5. 510(k) Summary
OCT 2 3 2012
Image /page/0/Picture/3 description: The image shows the logo for Neurostructures. The logo consists of a square divided into four smaller squares, with the top left square being solid black and the other three squares being grayscale. To the right of the square is the word "NEURO" in large, bold, sans-serif font, with the letters slightly spaced apart. Below "NEURO" is the word "STRUCTURES" in a smaller, sans-serif font, and above the "O" in "NEURO" is the trademark symbol.
| Submitter's Name: | NeuroStructures |
|---|---|
| Submitter's Address: | 63 Bovet Road, Suite 135 |
| San Mateo, CA 94402 | |
| Submitter's Telephone: | 800-352-6103 |
| Contact Name: | John Stephani |
| Date Summary was Prepared: | 18 May 2012 |
| Trade or Proprietary Name: | Resolute™ Facet Screw System |
| Common or Usual Name: | Screw, Fixation, Bone |
| Classification: | Unclassified |
| Product Codes: | MRW |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Device: | Spineology® Capture™ Facet Screw System (K092464) |
| NuVasive® Triad® Facet Screw System (K020411) |
Description of the Device Subject to Premarket Notification:
The Resolute Facet Screw System is comprised of various sized single-use, non-sterile facet screws that are designed to provide bilateral transfacet fixation of the lumbar facet joints. The system consists of titanium alloy (6AL-4v-EU per ASTM F136) screws in fully threaded and partially threaded designs, both of which are cannulated.
INDICATIONS FOR USE
The Resolute Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.
Resolute Facet Screw System
Pg lo82
1
Technical Characteristics
The Resolute Facet Screw System screws are manufactured from titanium alloy (6AL-4v-ELI per ASTM F136), similar to the referenced predicate devices. No new technical characteristics are being introduced with this product.
Performance Data
Cantilever testing and engineering analysis was completed on the Resolute Facet Screw System.
Conclusion
The overall technology characteristics and mechanical performance data lead to the conclusion that Resolute Facet Screw System is substantially equivalent to the predicate devices.
Resolute Facet Screw System
Pg 2002
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Neurostructures, LLC % Empirical Testing Corporation Ms. Meredith May, MS 4628 Northpark Drive Colorado Spring, Colorado 80918
Re: K121551
Trade/Device Name: Resolute Facet Screw System Regulatory Class: Unclassified Product Code: MRW Dated: September 06, 2012 Received: October 15, 2012
Dear Ms. May:
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.
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
OCT 23 2012
3
Page 2 – Ms. Meredith May, MS
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 Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.
Sincerely vours,
for
Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use Statement
Device Name: Resolute Facet Screw System
The Resolute Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
(Divisi Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
KIZISSI 510(k) Number_
Resolute Facet Screw System