(110 days)
No
The summary describes a mechanical implant device and its intended use, with no mention of AI or ML technology.
Yes.
The device is a permanent implant intended for posterior surgical treatment to provide mechanical support and stability to the spine for conditions like spondylolisthesis, spondylolysis, pseudarthrosis, and degenerative disc disease. Its purpose is to alleviate symptoms and aid in achieving biological fusion, fitting the definition of a therapeutic device.
No
The provided text explicitly states that the SS Fenestrated Facet Screw System (FFS) is a permanent implant device intended to provide mechanical support and stability. It is used for "posterior surgical treatment" and as a "delivery system for bone graft," which are therapeutic and supportive functions, not diagnostic ones.
No
The device description explicitly states it is a "permanent implant device made from Cobalt Chrome Alloy" and describes its physical characteristics and intended surgical implantation, indicating it is a hardware device.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro).
- Device Description: The SS Fenestrated Facet Screw System is described as a "permanent implant device" made from Cobalt Chrome Alloy. It is surgically implanted inside the body to provide mechanical support and stability to the spine.
- Intended Use: The intended use is for "posterior surgical treatment" of specific spinal conditions. This involves a surgical procedure and implantation, not laboratory testing of samples.
The information clearly indicates this is a surgical implant device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The SS Fenestrated Facet Screw System (FFS) is indicated for the posterior surgical treatment at L1-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability. The system is intended for use with only autogenous bone graft material.
Product codes
MRW
Device Description
The SS Fenestrated Facet Screw System (FFS) is a permanent implant device made from Cobalt Chrome Alloy Per ASTM 1537. It is to be implanted from the posterior approach. The device is provided in one diameter and multiple lengths to accommodate the various anatomy of the spine. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved. The SS Fenestrated Facet Screw System is cannulated and fenestrated which allows it to be used as a delivery system for bone graft. The system is not to be used with bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L1-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)
Testing of the FFS to demonstrate substantial equivalence included static and dynamic 3-point bending, screw axial pullout, and torque to failure. The testing standards utilized were, ASTM F543-07 "Standard Specification and Test Methods For Metallic Medical Bone Screws", F2193-02, "Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System," and ASTM F1264-03 "Standard Specification and Test Methods for Intramedullary Fixation Devices."
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
Section 5 - 510(k) Summary or 510(k) Statement
| APPLICANT: | Spectrum Spine IP Holdings, LLC
Atlanta, GA | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Dr. James Robinson
3045 Paces Lake Court
Atlanta, GA 30339
Tel: (404) 550-1335 | OCT 2 8 2013 |
| Application Correspondent: | Ottie Pendleton, Spectrum Spine, LLC
Tel: 404-372-0389
Email: ottie@spectrumspine.com | |
| PROPOSED TRADE NAME: | SS Fenestrated Facet Screw System | |
| PREPARATION DATE: | 10/22/13 | |
| DEVICE CLASSIFICATION: | Unclassified | |
| CLASSIFICATION NAME: | System, Facet Screw Spinal Device | |
| PRODUCT CODE: | MRW | |
| DEVICE DESCRIPTION: | The SS Fenestrated Facet Screw System (FFS) is a permanent implant device made
from Cobalt Chrome Alloy Per ASTM 1537. It is to be implanted from the
posterior approach. The device is provided in one diameter and multiple lengths
to accommodate the various anatomy of the spine. The device is intended to
provide mechanical support and stability to the implanted level until biologic
fusion is achieved. The SS Fenestrated Facet Screw System is cannulated and
fenestrated which allows it to be used as a delivery system for bone graft. The
system is not to be used with bone cement. | |
| INDICATIONS FOR USE: | The SS Fenestrated Facet Screw System (FFS) is indicated for the posterior surgical
treatment at L1-S1 (inclusive) spinal levels for the following: Spondylolisthesis;
Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic;
Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies and/or
degenerative disease of the facets with instability. The system is intended for use
with only autogenous bone graft material. | |
| MATERIALS: | Medical grade Cobalt Chrome Alloy. | |
| PREDICATE DEVICES: | • Trans1 Facet Screw (K073515)
• X-Spine Systems Zygafix Spinal Facet Screw System (K123932) | |
| TECHNOLOGIC
CHARACTERISTICS: | The fundamental scientific principles and technological characteristics, including
the intended use, general design, and sizes of the devices are the same as, or similar
to, the predicate devices. | |
| PERFORMANCE DATA: | Testing of the FFS to demonstrate substantial equivalence included static and
dynamic 3-point bending, screw axial pullout, and torque to failure. The testing
standards utilized were, ASTM F543-07 "Standard Specification and Test Methods
for Metallic Medical Bone Screws", F2193-02, "Standard Specifications and Test | |
1
Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System," and ASTM F1264-03 "Standard Specification and Test Methods for Intrameduliary Fixation Devices."
The Spectrum Spine Fenestrated Facet Screw System (FFS) is substantially SAFETY & EFFECTIVENESS: equivalent to the predicate device (K073515). The devices have the same "Indications for Use", are available by prescription only, and are provided nonsterile for single-use only. The device has fenestrations to allow for the optional packing of bone graft similar to the predicate (K123932). The FFS system differs from the predicates in that the FFS is made from Cobalt Chrome alloy while the predicates are made from Titanium alloy. This differences does not negatively impact the overall safety and effectiveness of the device. Therefore it can be concluded that the FFS is both a safe and effective device and is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human figure with three flowing lines, positioned to the right. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2013
Spectrum Spine, LLC Mr. Ottie Pendleton 3045 Pacer Lake Court Atlanta, Georgia 30339
Re: K132126
Trade/Device Name: Spectrum Spine (SS) Fenestrated Facet Screw System Regulatory Class: Unclassified Product Code: MRW Dated: July 17, 2013 Received: August 1, 2013
Dear Mr. Pendleton:
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 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.
3
Page 2 - Mr. Ottie Pendleton
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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.
Ronald帮剑ean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use Statement
510(k) Number: K132126
Device Name: Spectrum Spine Fenestrated Facet Screw System
The SS Fenestrated Facet Screw System (FFS) is indicated for the posterior surgical treatment at L1-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability. The system is intended for use with only autogenous bone graft material.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × or Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald®ªøJean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132126