(79 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its performance testing, with no mention of AI or ML.
Yes
The device is intended for supplemental fixation in various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, tumor) to achieve fusion and pain relief, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The device is a posterior, non-pedicle supplemental fixation device for spinal fusion, not a diagnostic tool.
No
The device description explicitly states that the system includes "various sizes of Titanium plate constructs" and "instrumentation for implantation," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "posterior, non-pedicle supplemental fixation device" for spinal fusion. This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details titanium plate constructs and instrumentation for implantation. This further confirms it's a physical device for surgical use.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The StabiLink™ MIS Spinal Fixation System is a posterior, non-pedicle supplemental fixation device. intended for use at a single level in the non-cervical spine (TI-S1). It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); tumor. It is not intended for stand-alone use.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The Stabilink™ MIS Spinal Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion. The system is implanted via a posterior approach to the spine. The StabiLink™ MIS Spinal Fixation System includes various sizes of Titanium plate constructs. There is instrumentation for implantation and a sterilization tray for steam sterilization. The implants are non-sterile and single use. The instrumentation is non-sterile and reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1)
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 StabiLink MIS Spinal Fixation System was tested to the ASTM F1717 standard as recognized by FDA as appropriate for characterization of posterior non-cervical non-pedicle systems. Testing included static and dynamic axial compression bending, and static and dynamic torsion. These tests were identified in "FDA Guidance for Industry and Staff - Spinal System 510(k)s", Dated May 3, 2004. Further guidance and discussion with FDA personnel led to additional requested testing for static tension testing using foam blocks, and dissociation testing using a modification of ASTM F1798 which tests the resistance to lateral loading of the component interconnection mechanisms. The ASTM F1717 tests were completed as direct comparison tests with the predicate devices. The results from the direct comparison demonstrate substantial equivalence for the static and dynamic axial compression bending, static and dynamic torsion, and the static tension testing. Dissociation testing was also completed.
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.
K071877, K083581, K090252, K100935, K103091, K121940, K032037
Reference Device(s):
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
§ 888.3050 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
DEC 2 1 2012
Southern Spine LLC Traditional 510(k) - Southern Spine - StabiLink™ MIS Spinal Fixation System
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.
| Submitted By: | Southern Spine LLC |
|---|---|
| 487 Cherry Street - Third Street Tower | |
| Macon, GA 31201 | |
| Phone: (478) 745-0000 | |
| Fax: (478) 744-9996 |
Julie Stephens, President/Consultant Contact Person: Regulatory Resources Group, Inc.
Date Submitted: November 29, 2012
Device Name and Classification:
| Trade/Proprietary Name: | StabiLink™ MIS Spinal Fixation System |
|---|---|
| Common Name: | Appliance, Fixation, Spinal Interlaminal |
| Classification Name: | Spinal interlaminal fixation orthosis |
| Product Code: | KWP |
Legally Marketed Predicate Device:
Lanx, Inc. - Lanx Spinal Fixation System (Includes Lanx Aspen and LPlate Systems) -510(k) # K071877 (Initial Aspen); K083581; K090252; K100935 (Initial LPlate); K103091; K121940
- Medtronic Sofamor Danek, Inc. CD HORIZON® Spinous Process Plate (Also called Spire™) - 510(k) # K032037
Device Description:
The Stabilink™ MIS Spinal Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion. The system is implanted via a posterior approach to the spine. The StabiLink™ MIS Spinal Fixation System includes various sizes of Titanium plate constructs. There is instrumentation for implantation and a sterilization tray for steam sterilization. The implants are non-sterile and single use. The instrumentation is non-sterile and reusable.
Indications for Use:
The StabiLink™ MIS Spinal Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-araphic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); tumor. It is not intended for stand-alone use.
1
Southern Spine LLC Traditional 510(k) - Southern Spine - StabiLink™ MIS Spinal Fixation System
510(k) SUMMARY
Similarities and Differences to the Predicate Devices:
Similarities
The StabiLink™ MIS Spinal Fixation System like the predicate devices uses a two piece construct that fits over the spinous process. All three devices use a sliding type mechanism between the two pieces which are then compressed into the bone and the construct is locked with a set screw. The same materials, same performance standards, and the same indications for use are used in the StabiLink and the predicate devices.
Differences
There are slight differences in the StabiLink when compared against the predicates. The StabiLink and the Spire both have four fixation spikes on each wing (two wings on each side piece of the plate construct) while the Lanx plates have three spikes on each wing. The StabiLink and Lanx have conical shaped fixation spikes while the Spire has pyramid shaped fixation spikes.
Summary of Testing:
The StabiLink MIS Spinal Fixation System was tested to the ASTM F1717 standard as recognized by FDA as appropriate for characterization of posterior non-cervical non-pedicle systems. Testing included static and dynamic axial compression bending, and static and dynamic torsion. These tests were identified in "FDA Guidance for Industry and Staff - Spinal System 510(k)s", Dated May 3, 2004. Further guidance and discussion with FDA personnel led to additional requested testing for static tension testing using foam blocks, and dissociation testing using a modification of ASTM F1798 which tests the resistance to lateral loading of the component interconnection mechanisms. The ASTM F1717 tests were completed as direct comparison tests with the predicate devices. The results from the direct comparison demonstrate substantial equivalence for the static and dynamic axial compression bending, static and dynamic torsion, and the static tension testing. Dissociation testing was also completed.
Substantial Equivalence Conclusions:
The StabiLink MIS Spinal Fixation System has the same intended use and indications for use, and the same or very similar technological characteristics and principles of operation as the predicate systems. The minor differences do not raise any issues of safety or effectiveness. Testing results support the determination of substantial equivalence with the results demonstrating that the StabiLink has equivalent or in some cases better results than the . predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines extending upwards, representing growth and vitality.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2012
Southern Spine, LLC % Ms. Julie Stephens President/Consultant 111 Laurel Ridge Drive Alpharetta, Georgia 30004
Re: K123093
Trade/Device Name: Southern Spine - StabiLink™ MIS Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: November 29, 2012 Received: November 30, 2012 ·
Dear Ms. Stephens:
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
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Page 2 - Ms. Julie Stephens
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson . Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Southern Spine - StabiLink™ MIS Spinal Fixation System
Indications for Use:
The StabiLink™ MIS Spinal Fixation System is a posterior, non-pedicle supplemental fixation device. intended for use at a single level in the non-cervical spine (TI-S1). It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); tumor. It is not intended for stand-alone use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123093
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