(170 days)
Not Found
No
The summary describes a mechanical bone fixation device and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to provide fixation of large bones and promote fusion in the treatment of degenerative sacroiliitis or sacroiliac joint disruptions, which are conditions requiring medical treatment.
No
This device is described as a "fixation device" intended to provide stability to the sacroiliac joint, promote fusion, and is used in the treatment of specific conditions. It is a therapeutic device, not one that gathers information about a patient's health status to diagnose a condition.
No
The device description clearly states it is a "partially threaded, fully cannulated, bone fixation device" and describes its physical components and mechanical properties, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "fixation of large bones, including the sacrum and ilium" and is used as an "adjunct to sacroiliac joint fusion." This describes a surgical implant used to stabilize bones.
- Device Description: The description details a "partially threaded, fully cannulated, bone fixation device" with features designed for securing it in bone and providing compression. This is consistent with a surgical implant.
- Lack of IVD Characteristics: An IVD is a medical device 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. It is a physical implant.
The information provided describes a surgical device used for bone fixation, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The SICONUS™ SI Joint Fixation System is intended to provide fixation of large bones, including the sacrum and ilium. It is intended for use in skeletally mature patients as an adjunct to sacroiliac joint fusion in the treatment of degenerative sacroiliitis, or sacroiliac joint disruptions.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The Camber Spine Technologies Siconus™ SI Joint Fixation System is a partially threaded, fully cannulated, bone fixation device that has a threaded distal end with a buttress-style profile in order to secure the device in cancellous bone. The proximal head of the device has a conical shape that provides axial compression of the bones across the sacroiliac joint in order to promote fusion. The head of the device also contains a tapered that allows the device to advance into hard cortical bone by displacing material, while also maintaining compression and preventing movement of the device. The proximal head and distal thread is connected by a smooth shaft. In the large version of the device, this shaft contains a slot along the axis to permit packing with bone graft to facilitate fusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacrum and ilium (Sacroiliac joint)
Indicated Patient Age Range
skeletally mature patients
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 tests performed indicate that the Siconus™ SI Joint Fixation System performs equally or better as compared to the predicate devices. Testing included static torsion, static bending, dynamic bending, and screw thread pullout per ASTM F2193-02 and ASTM F543-07. The results of these tests demonstrate that the subject device is equivalent or exceeds the acceptance criteria defined by equivalent tests performed on the predicate devices.
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.
Xtant (X-Spine) Silex™ SI Joint Fusion System (K123702), Synthes Cannulated Screw (K021932), Zyga SImmetry Sacroiliac Joint Fusion System (K102907)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 888.3040 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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures in profile facing right. The figures are stacked vertically, suggesting a sense of community and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 18, 2017
Camber Spine Technologies % Mr. Justin Eggleton Senior Director, Spine Regulatory Affairs MCRA, LLC 1331 H St NW, 12th Fl Washington, District of Columbia 20005
Re: K162121
Trade/Device Name: Siconus™ SI Joint Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: January 11, 2017 Received: January 13, 2017
Dear Mr. Eggleton:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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/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 Industry and Consumer Education 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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162121
Device Name Camber Spine Technologies SICONUSTM SI Joint Fixation System
Indications for Use (Describe)
The SICONUS™ SI Joint Fixation System is intended to provide fixation of large bones, including the sacrum and ilium. It is intended for use in skeletally mature patients as an adjunct to sacroiliac joint fusion in the treatment of degenerative sacroiliitis, or sacroiliac joint disruptions.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
| Trade Name | Siconus™ SI Joint Fixation System |
|---|---|
| Common Name | SI Joint Screw System / SI Joint Fixation System |
| Manufacturer | Camber Spine Technologies |
| 418 E. Lancaster Ave. | |
| Wayne, PA 19087 | |
| Contact | Justin Eggleton |
| Senior Director, Spine Regulatory Affairs | |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| jeggleton@mcra.com | |
| Prepared By | Mr. Damian Heinz, PE |
| Senior Principal Engineer | |
| Institute of Musculoskeletal Science and Education | |
| 418 E. Lancaster Ave. | |
| Wayne, PA 19087 | |
| Phone: 484.420.4286 x307 | |
| Fax: 484.318.8031 | |
| Date Prepared | January 17, 2017 |
| Device Class | Class II |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| Classification Number | 21 CFR §888.3040 |
| Classification Panel: | Orthopedic |
| Product Code | OUR |
| Reason for 510(k) | New Device |
| Predicate Device | Xtant (X-Spine) Silex™ SI Joint Fusion System (K123702) |
| Synthes Cannulated Screw (K021932) | |
| Zyga SImmetry Sacroiliac Joint Fusion System (K102907) |
Indications:
The Siconus™ SI Fixation System is intended to provide fixation and stabilization of large bones, including the sacrum and ilium. It is intended for use in skeletally mature patients as an adjunct
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to sacroiliac joint fusion in the treatment of the degenerative sacroiliitis, or sacroiliac joint disruptions.
Device Description:
The Camber Spine Technologies Siconus™ SI Joint Fixation System is a partially threaded, fully cannulated, bone fixation device that has a threaded distal end with a buttress-style profile in order to secure the device in cancellous bone. The proximal head of the device has a conical shape that provides axial compression of the bones across the sacroiliac joint in order to promote fusion. The head of the device also contains a tapered that allows the device to advance into hard cortical bone by displacing material, while also maintaining compression and preventing movement of the device. The proximal head and distal thread is connected by a smooth shaft. In the large version of the device, this shaft contains a slot along the axis to permit packing with bone graft to facilitate fusion.
Predicate Device:
The predicate devices selected for this 510(k) are the X-spine Silex™ SI Joint Fusion System (K123702), Synthes Cannulated Screw (K021932), and Zyga SImmetry Sacroiliac Joint Fusion System (K102907). The subject Siconus™ SI Fixation device is substantially equivalent to the predicate devices with respect to indications, intended use, design, function, and performance.
Substantial Equivalence:
The Siconus™ SI Joint Fixation System is considered to be equivalent in safety and effectiveness (i.e., "substantially equivalent") as the predicates, the X-spine Silex™ Sl Joint Fusion System (K123702), Synthes Cannulated Screw (K021932), and Zyga SImmetry Sacroiliac Joint Fusion System (K102907). All systems utilize comparable surgical techniques. All systems include implants and instruments that are manufactured using biocompatible materials with a long history of use in orthopedic surgery.
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Performance Testing:
Mechanical tests performed indicate that the Siconus™ SI Joint Fixation System performs equally or better as compared to the predicate devices. Testing included static torsion, static bending, dynamic bending, and screw thread pullout per ASTM F2193-02 and ASTM F543-07. The results of these tests demonstrate that the subject device is equivalent or exceeds the acceptance criteria defined by equivalent tests performed on the predicate devices.
Conclusion:
Camber Spine Technologies has provided sufficient information to demonstrate the Siconus™ SI Joint Fixation System is substantially equivalent to the predicate X-Spine Silex™ Sacroiliac Fusion Device (K123702), Synthes Cannulated Screw (K021932), and Zyga SImmetry Sacroiliac Joint Fusion System (K102907) with respect to indications, intended use, design, function, and performance.