Siconus SI Joint Fixation System

K162121 · Camber Spine Technologies · OUR · Jan 18, 2017 · Orthopedic

Device Facts

• Record ID: K162121
• Device Name: Siconus SI Joint Fixation System
• Applicant: Camber Spine Technologies
• Product Code: OUR · Orthopedic
• Decision Date: Jan 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Siconus™ SI Joint Fixation System is a partially threaded, fully cannulated metallic bone fixation device; features threaded distal end with buttress-style profile for cancellous bone fixation; proximal head has conical shape for axial compression across sacroiliac joint; smooth shaft connects head and distal thread; large version includes axial slot for bone graft packing to facilitate fusion. Used by orthopedic surgeons in clinical/surgical settings to stabilize sacroiliac joint; device provides mechanical fixation to promote fusion; benefits patient by stabilizing joint and treating degenerative sacroiliitis or disruptions.

Clinical Evidence

Bench testing only. Mechanical testing included static torsion, static bending, dynamic bending, and screw thread pullout per ASTM F2193-02 and ASTM F543-07. Results demonstrate performance equivalent to or exceeding predicate acceptance criteria.

Technological Characteristics

Partially threaded, fully cannulated metallic bone fixation fastener. Features buttress-style distal thread, conical proximal head, and smooth shaft (with axial slot in large version). Materials are biocompatible orthopedic-grade metals. Testing performed per ASTM F2193-02 and ASTM F543-07.

Indications for Use

Indicated for skeletally mature patients requiring fixation/stabilization of sacrum and ilium as an adjunct to sacroiliac joint fusion for degenerative sacroiliitis or sacroiliac joint disruptions.

Regulatory Classification

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.

Predicate Devices

• Xtant (X-Spine) Silex™ SI Joint Fusion System (K123702)
• Synthes Cannulated Screw (K021932)
• Zyga SImmetry Sacroiliac Joint Fusion System (K102907)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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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# 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: [phone] |
| | [e-mail] |
| Prepared By | Mr. Damian Heinz, PE |
| | Senior Principal Engineer |
| | Institute of Musculoskeletal Science and Education |
| | 418 E. Lancaster Ave. |
| | Wayne, PA 19087 |
| | Phone: [phone] x307 |
| | Fax: [phone] |
| 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.