(225 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "posterior, non-pedicle supplemental fixation device" intended for "achieving supplemental fusion" in the spine for conditions like degenerative disc disease, spondylolisthesis, trauma, and tumor, which directly addresses medical conditions to restore function or alleviate symptoms.
No
The SureFix Interspinous Fusion System is a supplemental fixation device intended for surgical implantation to promote fusion, not to diagnose medical conditions.
No
The device description explicitly states it is a family of posterior, non-pedicle, supplemental fixation devices manufactured from Titanium alloy, which are physical hardware implants.
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.
- SureFix System Function: The SureFix Interspinous Fusion System is a surgical implant designed to be placed directly into the spine to aid in fusion. It is a physical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test.
- Device Description: The description details a physical implant made of titanium alloy, not a reagent, instrument, or kit used for testing samples.
The information provided describes a surgical implant, which falls under the category of medical devices, but specifically not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SureFix Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The SureFix Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
Product codes
PEK
Device Description
The JG Spine SureFix Interspinous Fusion System device is a family of posterior, non-pedicle, supplemental fixation devices that are manufactured from Titanium alloy (per ASTM F136). More specifically, these devices are interspinous process implants that are offered in a variety of diameters and lengths and are clamped to two consecutive non-cervical spinous processes. The system is to be implanted from the posterior approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1 inclusive)
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 SureFix Interspinous Fusion System to demonstrate substantial equivalence included construct static compression bending, static torsion and dynamic compression bending according to ASTM F1717-11, and component level testing according to ASTM F543-07.
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
§ 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
.
Section 5 - 510(k) Summary
.
| APPLICANT: | JG Spine, LLC |
|---|---|
| Contact Person: | Greg Smith, Manager |
| 309 N Sea Lake Lane | |
| Ponte Vedra Beach, FL 32082 | |
| Tel: (904) 509-6030 | |
| Application Correspondent: | Kapstone Medical, LLC |
| 100 E. South Main St. | |
| P.O. Box 1458 | |
| Waxhaw, NC 28173 | |
| Contact Person: | John Kapitan, President, Kapstone Medical LLC |
| Tel: (704) 843-7852 | |
| Fax: (704) 831-5316 | |
| Email: jkapitan@kapstonemedical.com | |
| AUG 09 2013 | |
| PROPOSED TRADE NAME: | SureFix Interspinous Fusion System |
| PREPARATION DATE: | 08/08/13 |
| DEVICE CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Spinal Interlaminal Fixation Orthosis |
| REGULATION NUMBER: | 888.3050 |
| PRODUCT CODE: | PEK |
| DEVICE DESCRIPTION: | The JG Spine SureFix Interspinous Fusion System device is a family of posterior, |
| non-pedicle, supplemental fixation devices that are manufactured from Titanium | |
| alloy (per ASTM F136). More specifically, these devices are interspinous process | |
| implants that are offered in a variety of diameters and lengths and are clamped to | |
| two consecutive non-cervical spinous processes. The system is to be implanted | |
| from the posterior approach. | |
| INDICATIONS FOR USE: | The SureFix Interspinous Fusion System is a posterior, non-pedicle supplemental |
| fixation device, intended for use at a single level in the non-cervical spine (T1-S1 | |
| inclusive). It is intended for plate fixation/attachment to spinous processes for the | |
| purpose of achieving supplemental fusion in the following conditions: | |
| degenerative disc disease (defined as back pain of discogenic origin with | |
| degeneration of the disc confirmed by history and radiographic studies); | |
| spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The SureFix | |
| Interspinous Fusion System is intended for use with bone graft material, and not | |
| for stand-alone use. | |
| MATERIALS: | Medical grade Titanium alloy. |
| PREDICATE DEVICES: | Lanx Spinal System (K100935) |
| Axle Interspinous Fusion System (K101471) | |
| TECHNOLOGIC | |
| CHARACTERISTICS: | The fundamental scientific principles and technological characteristics of the |
| SureFix Interspinous Fusion System, including the intended use, general design, | |
| and sizes of the devices are the same as, or similar to, the predicate devices listed |
1
above.
Testing of the SureFix Interspinous Fusion System to demonstrate substantial PERFORMANCE DATA: equivalence included construct static compression bending, static torsion and dynamic compression bending according to ASTM F1717-11, and component level testing according to ASTM F543-07. SAFETY & EFFECTIVENESS: The JG Spine SureFix Interspinous Fusion System is substantially equivalent to the predicate Lanx device (K100935) and X-Spine device (K101471). The devices have the same "Indications for Use", share similar technological characteristics, are
CONCLUSION:
available by prescription only, and are provided non-sterile for single-use only. Materials of manufacture are also similar. Performance testing has shown that the SureFix Interspinous Fusion System is substantially equivalent to the predicate devices.
The SureFix Interspinous Fusion System is both a safe and effective device and is substantially equivalent to the predicate devices based on testing and comparison.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 9, 2013
JG Spine, LLC John Kapitan 100 E. South Main St. Waxhaw, NC 28173 US
Re: K124014
Trade/Device Name: SureFix Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: July 8, 2013 Received: July 12, 2013
Dear Mr. Kapitan:
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);
3
Page 2 - Mr. John Kapitan
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.htmfor 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.
Mark N. Melkerson -S
Mark N. Melkerson Division Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use Statement
Device Name: SureFix Interspinous Fusion System
The SureFix Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The SureFix Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
× Over-The-Counter Use __ Prescription Use _____________________________________________________________________________________________________________________________________________________________ or
(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)
Colin O'Neill
for RPJ
(Division Sign-Off) Division or Orthopedic Devices 510(k) Number: K124014