(147 days)
The SI-LOK™ Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
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.
This document describes the SI-LOK™ Sacroiliac Joint Fixation System, a medical device, and the basis for its clearance, which is substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria for a novel AI or diagnostic algorithm.
Therefore, many of the requested fields are not applicable to this type of device clearance. This submission does not involve an AI device or a diagnostic algorithm, but rather a mechanical fixation system.
Here's an analysis of the provided text with respect to your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Type of Test) | Reported Device Performance (Outcome) |
|---|---|
| Static cantilever bending | Conducted to demonstrate substantial equivalence to predicate devices. |
| Dynamic cantilever bending | Conducted to demonstrate substantial equivalence to predicate devices. |
| Screw insertion | Conducted to demonstrate substantial equivalence to predicate devices. |
| Screw pull-out | Conducted to demonstrate substantial equivalence to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The tests are mechanical, likely conducted in a lab setting rather than involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a mechanical device. "Ground truth" in the context of expert review of images or clinical outcomes is not relevant here. The "ground truth" for mechanical testing would be the physical properties and performance metrics measured according to established engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As this is mechanical testing, there is no adjudication of expert opinions.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study is not mentioned as this is a mechanical fixation system, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a mechanical fixation system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Mechanical Standards. For mechanical testing, the "ground truth" would be objective physical measurements against established engineering and material science standards (e.g., ASTM standards for titanium alloy properties, defined force limits for bending, pull-out, etc.). The document states the screws are made from titanium alloy "as specified in ASTM F136 and F1295" and HA coating "as specified in ASTM F1185," implying compliance with these mechanical and material standards.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set."
Summary of the Device and Study (as per the provided text):
The SI-LOK™ Sacroiliac Joint Fixation System is a mechanical device consisting of screws and washers designed for sacroiliac joint fusion. Its clearance (K112028) was based on demonstrating substantial equivalence to existing predicate devices (Synthes Cannulated Screw, DePuy Spine SIJF Cannulated Screw System, Zyga Technology Slmmetry Joint Fusion System).
The "study" that proves the device meets the acceptance criteria (substantial equivalence) involved mechanical testing, specifically:
- Static cantilever bending
- Dynamic cantilever bending
- Screw insertion
- Screw pull-out
These tests were performed to show that the SI-LOK™ system's performance is comparable to that of the already legally marketed predicate devices, in terms of indications, design, materials, and performance. The specific quantitative results of these tests and their comparison to the predicates are not detailed in this summary. The materials used (titanium alloy, HA coating) conform to established ASTM standards.
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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
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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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§ 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.