(16 days)
No
The description focuses on the mechanical properties and design of a surgical screw system 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 "SI Fusion System" intended for "fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion," which are therapeutic actions to treat a medical condition.
No
Explanation: This device is described as a "SI Fusion System" and is intended for "fixation of sacroiliac joint disruptions" and "sacroiliac joint fusion." These are surgical and therapeutic interventions, not diagnostic ones. The device consists of screws, which are implants for structural support, not tools for identifying or assessing a condition.
No
The device description explicitly details physical components made of titanium alloy, including screws and instruments, which are hardware.
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 FIREBIRD SI Fusion System is a surgical implant (screws) and associated instruments used to fix and fuse the sacroiliac joint. It is a physical device implanted into the body.
- Intended Use: The intended use is for the surgical fixation and fusion of the sacroiliac joint, not for testing bodily samples.
The information provided clearly describes a surgical implant system, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes
OUR
Device Description
The FIREBIRD SI Fusion System (formally SambaScrew 3D SI Fusion System) is a temporary multiple component system consisting of non-sterile instruments, sterile 11mm and 12mm FIREBIRD SI Screws and non-sterile 9mm FIREBIRD SI Screws. The FIREBIRD SI Screws are manufactured from medical-grade titanium alloy (Ti-6AI-4V ELI) with lengths ranging from 25mm to 70mm.
The 11mm FIREBIRD SI Screw is a cannulated screw featuring multiple fenestrations along the shaft, with a tapered proximal end and dual-pitch threads. The 12mm FIREBIRD SI Scew is a cannulated screw featuring multiple fenestrations along the shaft, with a single pitch thread on the proximal and distal ends. The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The 9mm FIREBIRD SI Screw features multiple fenestrations along the shaft and maintains a single pitch thread along the proximal and distal ends of the screw.
The FIREBIRD SI Fusion System allows for packing of autograft and allograft materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sacroiliac joint
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
Mechanical testing consisting of Static and Dynamic cantilever beam Test, Static Torsion Test and Static Axial Pull-Off Test were conducted in accordance to ASTM F2193 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System and in accordance to ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws.
Specifically for 9mm FIREBIRD SI Screws:
- Static cantilever beam test per ASTM F2193-18a Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System.
- Dynamic cantilever beam test per ASTM F2193-18a Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System.
- Static torsion test per ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws.
- Static axial pullout test per ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws.
Key Metrics
Not Found
Predicate Device(s)
K183342 - SambaScrew 3D SI Fusion System
Reference Device(s)
K121148 - SAMBA Screw System
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 2, 2020
Orthofix Inc. Jacki Koch Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K200696
Trade/Device Name: FIREBIRD SI Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: March 16, 2020 Received: March 17, 2020
Dear Ms. Koch:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'Neill, MBE Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200696
Device Name FIREBIRD SI Fusion System
Indications for Use (Describe)
The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in bold, black letters. A small registration mark is visible to the upper right of the word "ORTHOFIX".
FIREBIRD SI Fusion System
510(k) SUMMARY
FIREBIRD SI Fusion System (Formally SambaScrew 3D SI Fusion System)
| 510(k) Owner Information | |
|---|---|
| Name: | |
| Address: | Orthofix Inc. |
| 3451 Plano Parkway | |
| Lewisville, TX 75056 | |
| Telephone Number: | |
| Fax Number: | |
| Email: | 214-937-2100 |
| 214-937-3322 | |
| jackikoch@orthofix.com | |
| Registration Number: | 2183449 |
| Contact Person: | Jacki Koch, Senior Regulatory Affairs Specialist |
| Date Prepared: | March 16, 2020 |
| Name of Device | |
| Trade Name / Proprietary | |
| Name: | FIREBIRD SI Fusion System |
| Common Name: | Sacroiliac Joint Fixation Bone Screw |
| Product Code: | OUR |
| Regulatory Classification: | Class II – 21 CFR § 888.3040 |
| Review Panel: | Orthopedic Device Panel |
| Primary Predicate: | K183342 - SambaScrew 3D SI Fusion System |
| Reference Device: | K121148 - SAMBA Screw System |
Reason for 510(k) Submission: Due to advancements in surgeon requests, Orthofix is submitting this Special 510(k) premarket notification for the addition of the following device below to the previously cleared SambaScrew 3D SI Fusion System (K183342) now branded as the FIREBIRD SI Fusion System:
- . Addition of new 9mm FIREBIRD SI Screws
Device Description
The FIREBIRD SI Fusion System (formally SambaScrew 3D SI Fusion System) is a temporary multiple component system consisting of non-sterile instruments, sterile 11mm and 12mm FIREBIRD SI Screws and non-sterile 9mm FIREBIRD SI Screws. The FIREBIRD SI Screws are manufactured from medical-grade titanium alloy (Ti-6AI-4V ELI) with lengths ranging from 25mm to 70mm.
4
K200696 - Page 2 of 3
Image /page/4/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. The "®" symbol is located to the upper right of the "X" in "ORTHOFIX".
FIREBIRD SI Fusion System
The 11mm FIREBIRD SI Screw is a cannulated screw featuring multiple fenestrations along the shaft, with a tapered proximal end and dual-pitch threads. The 12mm FIREBIRD SI Scew is a cannulated screw featuring multiple fenestrations along the shaft, with a single pitch thread on the proximal and distal ends. The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The 9mm FIREBIRD SI Screw features multiple fenestrations along the shaft and maintains a single pitch thread along the proximal and distal ends of the screw.
The FIREBIRD SI Fusion System allows for packing of autograft and allograft materials.
Intended Use / Indications for Use
The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the FIREBIRD SI Fusion System are similar to the predicate (K183342 SambaScrew 3D SI Fusion System) in terms of intended use, indication for use and patient population. The subject 9mm FIREBIRD SI Screws are similar to the reference device (K121148 SAMBA Screw System) in terms of design and performance characteristics.
The technical characteristics of the subject device present no significant differences between the predicate and reference devices which would adversely affect the use of the product.
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
Mechanical testing consisting of Static and Dynamic cantilever beam Test. Static Torsion Test and Static Axial Pull-Off Test were conducted in accordance to ASTM F2193 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System and in accordance to ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws.
| Subject
| Device | Mechanical Testing | Appendix |
|---|---|---|
| Static cantilever beam test per | ||
| ASTM F2193-18a Standard | ||
| Specifications and Test Methods | ||
| for Components Used in the | ||
| Surgical Fixation of the Spinal | ||
| Skeletal System | Appendix B: Static Cantilever Beam Testing | |
| 10117508AA | ||
| 9mm | ||
| FIREBIRD | ||
| SI Screws | Dynamic cantilever beam test per | |
| ASTM F2193-18a Standard | ||
| Specifications and Test Methods | ||
| for Components Used in the | ||
| Surgical Fixation of the Spinal | ||
| Skeletal System | Appendix C: Dynamic Cantilever Beam | |
| Testing 10117509AA | ||
| Static torsion test per ASTM F543- | ||
| 17 Standard Specification and | ||
| Test Methods for Metallic Medical | ||
| Bone Screws | Appendix D: Static Torsion Testing | |
| 10117507AA |
Table 1: Mechanical Performance Testing
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Image /page/5/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. The "R" in "ORTHOFIX" has a registered trademark symbol next to it.
FIREBIRD SI Fusion System
| | Static axial pullout test per ASTM
F543-17 Standard Specification
and Test Methods for Metallic
Medical Bone Screws | Appendix E: Static Axial Pullout Testing
10117506AA |
| -- | ------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------- |
|---|
Conclusions
The addition of the 9mm FIREBIRD SI Screws to the previously cleared FIREBIRD SI Fusion System (formally known as SambaScrew 3D SI Fusion System) does not change the previously cleared (K183342) indications for use, intended use, contraindications, warnings or precautions. Furthermore, the surgical approach and implantation technique remains the same as previously cleared (K183342).
The performance and technological characteristics of the subject device are similar to the reference device (K121148) in terms of design, materials and performance characteristics.
There are no significant differences between the subject device, predicate device and reference device, which would adversely affect the use of the product.