(147 days)
Not Found
No
The device description focuses on the mechanical components (screws, washers) and materials, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is described as a "Sacroiliac Joint Fixation System" intended for "sacroiliac joint fusion" and to "provide fixation of large bones and large bone fragments of the pelvis," which are therapeutic interventions.
No
The device is a fixation system for sacroiliac joint fusion, which is a treatment, not a diagnostic procedure.
No
The device description explicitly states it consists of screws and washers made from titanium alloy, which are physical hardware components.
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 SI-LOK™ Sacroiliac Joint Fixation System is a system of screws designed for surgical implantation to fix and fuse the sacroiliac joint. It is a physical implant used within the body, not a device used to test samples outside the body.
- Intended Use: The intended use is for sacroiliac joint fusion, a surgical procedure.
The information provided clearly describes a surgical implant, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The SI-LOK Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Product codes
HWC, OUR
Device Description
The SI-LOK Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac ioint fusion and to provide fixation of large bones and large bone fragments of the pelvis. The cannulated partially threaded or fully threaded screws contain a preassembled contouring washer, and are offered in various diameters and lengths to accommodate patient anatomy. Optional screws may be used for supplemental screw fixation.
The SI-LOK Sacroiliac Joint Fixation System screws and pre-assembled contouring washers are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws are available with or without hydroxyapatite (HA) coated, as specified in ASTM F1185.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint, pelvis
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)
Mechanical testing, including static and dynamic cantilever bending and screw insertion and pull-out were conducted to demonstrate substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K021932, K962011, K051296, K111801, K110512
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) SUMMARY: SI-LOK™ Sacroiliac Joint Fixation System
Company: Globus Medical 2560 General Armistead Avenue Audubon, PA 19403 (610) 930-1800
- Wendy S. Hills Contact: Project Manager, Regulatory Affairs
Date Prepared: July 13, 2011
Device Name: SI-LOK™ Sacroiliac Joint Fixation System
Classification: Per 21 CFR as follows: §888.3040: Smooth or threaded metallic bone fixation fastener Product Codes: HWC, OUR Regulatory Class: II, Panel Code: 87
Synthes Cannulated Screw (K021932) Predicate(s): SE date: September 6, 2002, re-evaluated April 7, 2011 Synthes Cannulated Screw (K962011) SE date: August 5, 1996 DePuy Spine SIJF Cannulated Screw System (K051296) SE date: August 26, 2005, re-evaluated April 7, 2011 Zyga Technology Slmmetry Joint Fusion System (K111801, K110512) SE date: July 21, 2011, March 23, 2011
Purpose:
The purpose of this submission is to request clearance for the SI-LOK™ Sacroiliac Joint Fixation System.
Device Description:
The SI-LOK™ Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac ioint fusion and to provide fixation of large bones and large bone fragments of the pelvis. The cannulated partially threaded or fully threaded screws contain a preassembled contouring washer, and are offered in various diameters and lengths to accommodate patient anatomy. Optional screws may be used for supplemental screw fixation.
The SI-LOK™ Sacroiliac Joint Fixation System screws and pre-assembled contouring washers are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws are available with or without hydroxyapatite (HA) coated, as specified in ASTM F1185.
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Indications for Use:
The SI-LOK™ Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Performance Data:
Mechanical testing, including static and dynamic cantilever bending and screw insertion and pull-out were conducted to demonstrate substantial equivalence to the predicate devices.
Basis for Substantial Equivalence:
The SI-LOK™ Sacroiliac Joint Fixation System is substantially equivalent to legally marketed predicate devices in terms of indications, design, materials, and performance.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Globus Medical % Ms. Wendy S. Hills Project Manager, Regulatory Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
DEC - 9 2011
Re: K112028
Trade/Device Name: SI-LOK™ Sacroiliac Joint Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, OUR Dated: December 1, 2011 Received: December 2, 2011
Dear Ms. Hills:
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. Wendy S. Hills
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,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: K112028 SI-LOK™ Sacroiliac Joint Fixation System Device Name:
OR
Indications:
The SI-LOK™ Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Prescription Use _ × (Per 21 CFR §801.109) Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ichal Ores fo mxm
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112028
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